A randomised controlled trial of a mitochondrial therapeutic target for bipolar depression: mitochondrial agents, N-acetylcysteine, and placebo.
Identifieur interne : 000B63 ( Main/Exploration ); précédent : 000B62; suivant : 000B64A randomised controlled trial of a mitochondrial therapeutic target for bipolar depression: mitochondrial agents, N-acetylcysteine, and placebo.
Auteurs : Michael Berk [Australie] ; Alyna Turner [Australie] ; Gin S. Malhi [Australie] ; Chee H. Ng [Australie] ; Susan M. Cotton [Australie] ; Seetal Dodd [Australie] ; Yuval Samuni [Australie] ; Michelle Tanious [Australie] ; Claire Mcaulay [Australie] ; Nathan Dowling [Australie] ; Jerome Sarris [Australie] ; Lauren Owen [Royaume-Uni] ; Astrid Waterdrinker [Australie] ; Deidre Smith [Australie] ; Olivia M. Dean [Australie]Source :
- BMC medicine [ 1741-7015 ] ; 2019.
Descripteurs français
- KwdFr :
- Acétylcystéine (usage thérapeutique), Adulte (MeSH), Adulte d'âge moyen (MeSH), Association thérapeutique (méthodes), Compléments alimentaires (MeSH), Femelle (MeSH), Humains (MeSH), Mitochondries (effets des médicaments et des substances chimiques), Mâle (MeSH), Méthode en double aveugle (MeSH), Résultat thérapeutique (MeSH), Trouble bipolaire (traitement médicamenteux).
- MESH :
- effets des médicaments et des substances chimiques : Mitochondries.
- méthodes : Association thérapeutique.
- traitement médicamenteux : Trouble bipolaire.
- usage thérapeutique : Acétylcystéine.
- Adulte, Adulte d'âge moyen, Compléments alimentaires, Femelle, Humains, Mâle, Méthode en double aveugle, Résultat thérapeutique.
English descriptors
- KwdEn :
- MESH :
- chemical , therapeutic use : Acetylcysteine.
- drug effects : Mitochondria.
- drug therapy : Bipolar Disorder.
- methods : Combined Modality Therapy.
- Adult, Dietary Supplements, Double-Blind Method, Female, Humans, Male, Middle Aged, Treatment Outcome.
Abstract
BACKGROUND
A phasic dysregulation of mitochondrial bioenergetics may operate in bipolar disorder, increased in mania and decreased in depression. We aimed to examine efficacy of two add-on treatments in bipolar depression: N-acetylcysteine (NAC) and NAC with a combination of nutraceutical agents that may increase mitochondrial biogenesis.
METHODS
A three-arm 16-week, double-blind, randomised, placebo-controlled trial, adjunctive to usual treatment, was conducted. Participants (n = 181) with bipolar disorder and current depressive symptoms were randomised to 2000 mg/day NAC (n = 59), 2000 mg/day NAC with the combination nutraceutical treatment (CT, n = 61), or placebo (n = 61). The primary outcome was change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to week 16. Young Mania Rating Scale, Clinical Global Impression (CGI)-Improvement and CGI-Severity scales, Patient Global Impression scale, Social and Occupational Functioning Assessment Scale (SOFAS), Longitudinal Interval Follow-Up Evaluation - Range of Impaired Functioning Tool (LIFE-RIFT), and Quality of Life Enjoyment, and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) were secondary outcomes.
RESULTS
One hundred forty-eight participants had post-randomisation data and were analysed (NAC = 52, CT = 47, Placebo = 49). No between-group differences were found for the rate of change between baseline and 16 weeks on any of the clinical and functioning variables. Improvements in MADRS, BDRS, SOFAS, and LIFE-RIFT scores from baseline to the week 20 post-discontinuation visit were significantly greater in the CT group compared to those in the placebo. At week 20, the CGI-I was significantly lower in the CT group versus placebo. Gastrointestinal symptoms were significantly greater in the NAC than in the placebo group.
CONCLUSIONS
These overall negative results, with no significant differences between groups detected at the primary outcome but some positive secondary signals, suggest either delayed benefit of the combination or an improvement of symptoms on withdrawal which warrants further exploration regarding the composition, mechanisms, and application of mitochondrial agents in illnesses characterised by mitochondrial dysfunction.
TRIAL REGISTRATION
ANZCTR ( ACTRN12612000830897 ).
DOI: 10.1186/s12916-019-1257-1
PubMed: 30678686
PubMed Central: PMC6346513
Affiliations:
- Australie, Royaume-Uni
- Nouvelle-Galles du Sud, Victoria (État)
- Melbourne, Sydney
- Université de Melbourne, Université de Sydney
Links toward previous steps (curation, corpus...)
Le document en format XML
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Box 291, Geelong, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>IMPACT Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, P.O. 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Ng</name><affiliation wicri:level="4"><nlm:affiliation>Department of Psychiatry, University of Melbourne, the Melbourne Clinic, 130 Church St Richmond, Melbourne, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Psychiatry, University of Melbourne, the Melbourne Clinic, 130 Church St Richmond, Melbourne, VIC</wicri:regionArea><orgName type="university">Université de Melbourne</orgName><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Cotton, Susan M" sort="Cotton, Susan M" uniqKey="Cotton S" first="Susan M" last="Cotton">Susan M. Cotton</name><affiliation wicri:level="1"><nlm:affiliation>Orygen, The National Centre of Excellence in Youth Mental Health, 35 Poplar Rd, Parkville, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Orygen, The National Centre of Excellence in Youth Mental Health, 35 Poplar Rd, Parkville, VIC</wicri:regionArea><wicri:noRegion>VIC</wicri:noRegion></affiliation><affiliation wicri:level="4"><nlm:affiliation>Centre for Youth Mental Health, The University of Melbourne, 35 Poplar Rd, Parkville, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Centre for Youth Mental Health, The University of Melbourne, 35 Poplar Rd, Parkville, VIC</wicri:regionArea><orgName type="university">Université de Melbourne</orgName><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Dodd, Seetal" sort="Dodd, Seetal" uniqKey="Dodd S" first="Seetal" last="Dodd">Seetal Dodd</name><affiliation wicri:level="1"><nlm:affiliation>IMPACT Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, P.O. Box 291, Geelong, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>IMPACT Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, P.O. Box 291, Geelong, VIC</wicri:regionArea><wicri:noRegion>VIC</wicri:noRegion></affiliation><affiliation wicri:level="4"><nlm:affiliation>Department of Psychiatry, University of Melbourne, Royal Melbourne Hospital, Level 1 North, Main Block, Parkville, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Psychiatry, University of Melbourne, Royal Melbourne Hospital, Level 1 North, Main Block, Parkville, VIC</wicri:regionArea><orgName type="university">Université de Melbourne</orgName><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation><affiliation wicri:level="4"><nlm:affiliation>Centre for Youth Mental Health, The University of Melbourne, 35 Poplar Rd, Parkville, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Centre for Youth Mental Health, The University of Melbourne, 35 Poplar Rd, Parkville, VIC</wicri:regionArea><orgName type="university">Université de Melbourne</orgName><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Samuni, Yuval" sort="Samuni, Yuval" uniqKey="Samuni Y" first="Yuval" last="Samuni">Yuval Samuni</name><affiliation wicri:level="1"><nlm:affiliation>IMPACT Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, P.O. Box 291, Geelong, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>IMPACT Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, P.O. Box 291, Geelong, VIC</wicri:regionArea><wicri:noRegion>VIC</wicri:noRegion></affiliation></author><author><name sortKey="Tanious, Michelle" sort="Tanious, Michelle" uniqKey="Tanious M" first="Michelle" last="Tanious">Michelle Tanious</name><affiliation wicri:level="1"><nlm:affiliation>CADE Clinic, Royal North Shore Hospital, Northern Sydney Local Health District, St Leonards, NSW, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>CADE Clinic, Royal North Shore Hospital, Northern Sydney Local Health District, St Leonards, NSW</wicri:regionArea><wicri:noRegion>NSW</wicri:noRegion></affiliation></author><author><name sortKey="Mcaulay, Claire" sort="Mcaulay, Claire" uniqKey="Mcaulay C" first="Claire" last="Mcaulay">Claire Mcaulay</name><affiliation wicri:level="1"><nlm:affiliation>CADE Clinic, Royal North Shore Hospital, Northern Sydney Local Health District, St Leonards, NSW, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>CADE Clinic, Royal North Shore Hospital, Northern Sydney Local Health District, St Leonards, NSW</wicri:regionArea><wicri:noRegion>NSW</wicri:noRegion></affiliation></author><author><name sortKey="Dowling, Nathan" sort="Dowling, Nathan" uniqKey="Dowling N" first="Nathan" last="Dowling">Nathan Dowling</name><affiliation wicri:level="4"><nlm:affiliation>Department of Psychiatry, University of Melbourne, the Melbourne Clinic, 130 Church St Richmond, Melbourne, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Psychiatry, University of Melbourne, the Melbourne Clinic, 130 Church St Richmond, Melbourne, VIC</wicri:regionArea><orgName type="university">Université de Melbourne</orgName><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Sarris, Jerome" sort="Sarris, Jerome" uniqKey="Sarris J" first="Jerome" last="Sarris">Jerome Sarris</name><affiliation wicri:level="4"><nlm:affiliation>Department of Psychiatry, University of Melbourne, the Melbourne Clinic, 130 Church St Richmond, Melbourne, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Psychiatry, University of Melbourne, the Melbourne Clinic, 130 Church St Richmond, Melbourne, VIC</wicri:regionArea><orgName type="university">Université de Melbourne</orgName><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation><affiliation wicri:level="1"><nlm:affiliation>NICM, School of Health and Science, Western Sydney University, Campbelltown, NSW, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>NICM, School of Health and Science, Western Sydney University, Campbelltown, NSW</wicri:regionArea><wicri:noRegion>NSW</wicri:noRegion></affiliation></author><author><name sortKey="Owen, Lauren" sort="Owen, Lauren" uniqKey="Owen L" first="Lauren" last="Owen">Lauren Owen</name><affiliation wicri:level="1"><nlm:affiliation>School of Psychology, University of Central Lancashire, Preston, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>School of Psychology, University of Central Lancashire, Preston</wicri:regionArea><wicri:noRegion>Preston</wicri:noRegion></affiliation></author><author><name sortKey="Waterdrinker, Astrid" sort="Waterdrinker, Astrid" uniqKey="Waterdrinker A" first="Astrid" last="Waterdrinker">Astrid Waterdrinker</name><affiliation wicri:level="1"><nlm:affiliation>Melbourne Health, 300 Grattan St, Melbourne, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Melbourne Health, 300 Grattan St, Melbourne, VIC</wicri:regionArea><wicri:noRegion>VIC</wicri:noRegion></affiliation></author><author><name sortKey="Smith, Deidre" sort="Smith, Deidre" uniqKey="Smith D" first="Deidre" last="Smith">Deidre Smith</name><affiliation wicri:level="4"><nlm:affiliation>Department of Psychiatry, University of Melbourne, the Melbourne Clinic, 130 Church St Richmond, Melbourne, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Psychiatry, University of Melbourne, the Melbourne Clinic, 130 Church St Richmond, Melbourne, VIC</wicri:regionArea><orgName type="university">Université de Melbourne</orgName><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Dean, Olivia M" sort="Dean, Olivia M" uniqKey="Dean O" first="Olivia M" last="Dean">Olivia M. Dean</name><affiliation wicri:level="1"><nlm:affiliation>IMPACT Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, P.O. Box 291, Geelong, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>IMPACT Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, P.O. Box 291, Geelong, VIC</wicri:regionArea><wicri:noRegion>VIC</wicri:noRegion></affiliation><affiliation wicri:level="4"><nlm:affiliation>Department of Psychiatry, University of Melbourne, Royal Melbourne Hospital, Level 1 North, Main Block, Parkville, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Psychiatry, University of Melbourne, Royal Melbourne Hospital, Level 1 North, Main Block, Parkville, VIC</wicri:regionArea><orgName type="university">Université de Melbourne</orgName><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation><affiliation wicri:level="4"><nlm:affiliation>Florey Institute for Neuroscience and Mental Health, University of Melbourne, Kenneth Myer Building, 30 Royal Parade, Parkville, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Florey Institute for Neuroscience and Mental Health, University of Melbourne, Kenneth Myer Building, 30 Royal Parade, Parkville, VIC</wicri:regionArea><orgName type="university">Université de Melbourne</orgName><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2019">2019</date><idno type="RBID">pubmed:30678686</idno><idno type="pmid">30678686</idno><idno type="doi">10.1186/s12916-019-1257-1</idno><idno type="pmc">PMC6346513</idno><idno type="wicri:Area/Main/Corpus">000A67</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000A67</idno><idno type="wicri:Area/Main/Curation">000A67</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Curation">000A67</idno><idno type="wicri:Area/Main/Exploration">000A67</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">A randomised controlled trial of a mitochondrial therapeutic target for bipolar depression: mitochondrial agents, N-acetylcysteine, and placebo.</title><author><name sortKey="Berk, Michael" sort="Berk, Michael" uniqKey="Berk M" first="Michael" last="Berk">Michael Berk</name><affiliation wicri:level="1"><nlm:affiliation>IMPACT Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, P.O. Box 291, Geelong, VIC, Australia. mikebe@barwonhealth.org.au.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>IMPACT Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, P.O. Box 291, Geelong, VIC</wicri:regionArea><wicri:noRegion>VIC</wicri:noRegion></affiliation><affiliation wicri:level="4"><nlm:affiliation>Department of Psychiatry, University of Melbourne, Royal Melbourne Hospital, Level 1 North, Main Block, Parkville, VIC, Australia. mikebe@barwonhealth.org.au.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Psychiatry, University of Melbourne, Royal Melbourne Hospital, Level 1 North, Main Block, Parkville, VIC</wicri:regionArea><orgName type="university">Université de Melbourne</orgName><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation><affiliation wicri:level="4"><nlm:affiliation>Florey Institute for Neuroscience and Mental Health, University of Melbourne, Kenneth Myer Building, 30 Royal Parade, Parkville, VIC, Australia. mikebe@barwonhealth.org.au.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Florey Institute for Neuroscience and Mental Health, University of Melbourne, Kenneth Myer Building, 30 Royal Parade, Parkville, VIC</wicri:regionArea><orgName type="university">Université de Melbourne</orgName><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation><affiliation wicri:level="1"><nlm:affiliation>Orygen, The National Centre of Excellence in Youth Mental Health, 35 Poplar Rd, Parkville, VIC, Australia. mikebe@barwonhealth.org.au.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Orygen, The National Centre of Excellence in Youth Mental Health, 35 Poplar Rd, Parkville, VIC</wicri:regionArea><wicri:noRegion>VIC</wicri:noRegion></affiliation></author><author><name sortKey="Turner, Alyna" sort="Turner, Alyna" uniqKey="Turner A" first="Alyna" last="Turner">Alyna Turner</name><affiliation wicri:level="1"><nlm:affiliation>IMPACT Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, P.O. Box 291, Geelong, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>IMPACT Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, P.O. Box 291, Geelong, VIC</wicri:regionArea><wicri:noRegion>VIC</wicri:noRegion></affiliation><affiliation wicri:level="4"><nlm:affiliation>Department of Psychiatry, University of Melbourne, Royal Melbourne Hospital, Level 1 North, Main Block, Parkville, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Psychiatry, University of Melbourne, Royal Melbourne Hospital, Level 1 North, Main Block, Parkville, VIC</wicri:regionArea><orgName type="university">Université de Melbourne</orgName><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation><affiliation wicri:level="1"><nlm:affiliation>School of Medicine and Public Health, Faculty of Health and Medicine, the University of Newcastle, Callaghan, NSW, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>School of Medicine and Public Health, Faculty of Health and Medicine, the University of Newcastle, Callaghan, NSW</wicri:regionArea><wicri:noRegion>NSW</wicri:noRegion></affiliation></author><author><name sortKey="Malhi, Gin S" sort="Malhi, Gin S" uniqKey="Malhi G" first="Gin S" last="Malhi">Gin S. Malhi</name><affiliation wicri:level="1"><nlm:affiliation>CADE Clinic, Royal North Shore Hospital, Northern Sydney Local Health District, St Leonards, NSW, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>CADE Clinic, Royal North Shore Hospital, Northern Sydney Local Health District, St Leonards, NSW</wicri:regionArea><wicri:noRegion>NSW</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:affiliation>Academic Department of Psychiatry, Kolling Institute, Northern Sydney Local Health District, St Leonards, NSW, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Academic Department of Psychiatry, Kolling Institute, Northern Sydney Local Health District, St Leonards, NSW</wicri:regionArea><wicri:noRegion>NSW</wicri:noRegion></affiliation><affiliation wicri:level="4"><nlm:affiliation>ARCHI, Sydney Medical School Northern, University of Sydney, Sydney, NSW, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>ARCHI, Sydney Medical School Northern, University of Sydney, Sydney, NSW</wicri:regionArea><orgName type="university">Université de Sydney</orgName><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation></author><author><name sortKey="Ng, Chee H" sort="Ng, Chee H" uniqKey="Ng C" first="Chee H" last="Ng">Chee H. Ng</name><affiliation wicri:level="4"><nlm:affiliation>Department of Psychiatry, University of Melbourne, the Melbourne Clinic, 130 Church St Richmond, Melbourne, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Psychiatry, University of Melbourne, the Melbourne Clinic, 130 Church St Richmond, Melbourne, VIC</wicri:regionArea><orgName type="university">Université de Melbourne</orgName><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Cotton, Susan M" sort="Cotton, Susan M" uniqKey="Cotton S" first="Susan M" last="Cotton">Susan M. Cotton</name><affiliation wicri:level="1"><nlm:affiliation>Orygen, The National Centre of Excellence in Youth Mental Health, 35 Poplar Rd, Parkville, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Orygen, The National Centre of Excellence in Youth Mental Health, 35 Poplar Rd, Parkville, VIC</wicri:regionArea><wicri:noRegion>VIC</wicri:noRegion></affiliation><affiliation wicri:level="4"><nlm:affiliation>Centre for Youth Mental Health, The University of Melbourne, 35 Poplar Rd, Parkville, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Centre for Youth Mental Health, The University of Melbourne, 35 Poplar Rd, Parkville, VIC</wicri:regionArea><orgName type="university">Université de Melbourne</orgName><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Dodd, Seetal" sort="Dodd, Seetal" uniqKey="Dodd S" first="Seetal" last="Dodd">Seetal Dodd</name><affiliation wicri:level="1"><nlm:affiliation>IMPACT Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, P.O. Box 291, Geelong, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>IMPACT Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, P.O. Box 291, Geelong, VIC</wicri:regionArea><wicri:noRegion>VIC</wicri:noRegion></affiliation><affiliation wicri:level="4"><nlm:affiliation>Department of Psychiatry, University of Melbourne, Royal Melbourne Hospital, Level 1 North, Main Block, Parkville, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Psychiatry, University of Melbourne, Royal Melbourne Hospital, Level 1 North, Main Block, Parkville, VIC</wicri:regionArea><orgName type="university">Université de Melbourne</orgName><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation><affiliation wicri:level="4"><nlm:affiliation>Centre for Youth Mental Health, The University of Melbourne, 35 Poplar Rd, Parkville, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Centre for Youth Mental Health, The University of Melbourne, 35 Poplar Rd, Parkville, VIC</wicri:regionArea><orgName type="university">Université de Melbourne</orgName><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Samuni, Yuval" sort="Samuni, Yuval" uniqKey="Samuni Y" first="Yuval" last="Samuni">Yuval Samuni</name><affiliation wicri:level="1"><nlm:affiliation>IMPACT Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, P.O. Box 291, Geelong, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>IMPACT Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, P.O. Box 291, Geelong, VIC</wicri:regionArea><wicri:noRegion>VIC</wicri:noRegion></affiliation></author><author><name sortKey="Tanious, Michelle" sort="Tanious, Michelle" uniqKey="Tanious M" first="Michelle" last="Tanious">Michelle Tanious</name><affiliation wicri:level="1"><nlm:affiliation>CADE Clinic, Royal North Shore Hospital, Northern Sydney Local Health District, St Leonards, NSW, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>CADE Clinic, Royal North Shore Hospital, Northern Sydney Local Health District, St Leonards, NSW</wicri:regionArea><wicri:noRegion>NSW</wicri:noRegion></affiliation></author><author><name sortKey="Mcaulay, Claire" sort="Mcaulay, Claire" uniqKey="Mcaulay C" first="Claire" last="Mcaulay">Claire Mcaulay</name><affiliation wicri:level="1"><nlm:affiliation>CADE Clinic, Royal North Shore Hospital, Northern Sydney Local Health District, St Leonards, NSW, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>CADE Clinic, Royal North Shore Hospital, Northern Sydney Local Health District, St Leonards, NSW</wicri:regionArea><wicri:noRegion>NSW</wicri:noRegion></affiliation></author><author><name sortKey="Dowling, Nathan" sort="Dowling, Nathan" uniqKey="Dowling N" first="Nathan" last="Dowling">Nathan Dowling</name><affiliation wicri:level="4"><nlm:affiliation>Department of Psychiatry, University of Melbourne, the Melbourne Clinic, 130 Church St Richmond, Melbourne, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Psychiatry, University of Melbourne, the Melbourne Clinic, 130 Church St Richmond, Melbourne, VIC</wicri:regionArea><orgName type="university">Université de Melbourne</orgName><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Sarris, Jerome" sort="Sarris, Jerome" uniqKey="Sarris J" first="Jerome" last="Sarris">Jerome Sarris</name><affiliation wicri:level="4"><nlm:affiliation>Department of Psychiatry, University of Melbourne, the Melbourne Clinic, 130 Church St Richmond, Melbourne, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Psychiatry, University of Melbourne, the Melbourne Clinic, 130 Church St Richmond, Melbourne, VIC</wicri:regionArea><orgName type="university">Université de Melbourne</orgName><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation><affiliation wicri:level="1"><nlm:affiliation>NICM, School of Health and Science, Western Sydney University, Campbelltown, NSW, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>NICM, School of Health and Science, Western Sydney University, Campbelltown, NSW</wicri:regionArea><wicri:noRegion>NSW</wicri:noRegion></affiliation></author><author><name sortKey="Owen, Lauren" sort="Owen, Lauren" uniqKey="Owen L" first="Lauren" last="Owen">Lauren Owen</name><affiliation wicri:level="1"><nlm:affiliation>School of Psychology, University of Central Lancashire, Preston, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>School of Psychology, University of Central Lancashire, Preston</wicri:regionArea><wicri:noRegion>Preston</wicri:noRegion></affiliation></author><author><name sortKey="Waterdrinker, Astrid" sort="Waterdrinker, Astrid" uniqKey="Waterdrinker A" first="Astrid" last="Waterdrinker">Astrid Waterdrinker</name><affiliation wicri:level="1"><nlm:affiliation>Melbourne Health, 300 Grattan St, Melbourne, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Melbourne Health, 300 Grattan St, Melbourne, VIC</wicri:regionArea><wicri:noRegion>VIC</wicri:noRegion></affiliation></author><author><name sortKey="Smith, Deidre" sort="Smith, Deidre" uniqKey="Smith D" first="Deidre" last="Smith">Deidre Smith</name><affiliation wicri:level="4"><nlm:affiliation>Department of Psychiatry, University of Melbourne, the Melbourne Clinic, 130 Church St Richmond, Melbourne, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Psychiatry, University of Melbourne, the Melbourne Clinic, 130 Church St Richmond, Melbourne, VIC</wicri:regionArea><orgName type="university">Université de Melbourne</orgName><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Dean, Olivia M" sort="Dean, Olivia M" uniqKey="Dean O" first="Olivia M" last="Dean">Olivia M. Dean</name><affiliation wicri:level="1"><nlm:affiliation>IMPACT Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, P.O. Box 291, Geelong, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>IMPACT Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, P.O. Box 291, Geelong, VIC</wicri:regionArea><wicri:noRegion>VIC</wicri:noRegion></affiliation><affiliation wicri:level="4"><nlm:affiliation>Department of Psychiatry, University of Melbourne, Royal Melbourne Hospital, Level 1 North, Main Block, Parkville, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Psychiatry, University of Melbourne, Royal Melbourne Hospital, Level 1 North, Main Block, Parkville, VIC</wicri:regionArea><orgName type="university">Université de Melbourne</orgName><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation><affiliation wicri:level="4"><nlm:affiliation>Florey Institute for Neuroscience and Mental Health, University of Melbourne, Kenneth Myer Building, 30 Royal Parade, Parkville, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Florey Institute for Neuroscience and Mental Health, University of Melbourne, Kenneth Myer Building, 30 Royal Parade, Parkville, VIC</wicri:regionArea><orgName type="university">Université de Melbourne</orgName><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author></analytic><series><title level="j">BMC medicine</title><idno type="eISSN">1741-7015</idno><imprint><date when="2019" type="published">2019</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Acetylcysteine (therapeutic use)</term><term>Adult (MeSH)</term><term>Bipolar Disorder (drug therapy)</term><term>Combined Modality Therapy (methods)</term><term>Dietary Supplements (MeSH)</term><term>Double-Blind Method (MeSH)</term><term>Female (MeSH)</term><term>Humans (MeSH)</term><term>Male (MeSH)</term><term>Middle Aged (MeSH)</term><term>Mitochondria (drug effects)</term><term>Treatment Outcome (MeSH)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Acétylcystéine (usage thérapeutique)</term><term>Adulte (MeSH)</term><term>Adulte d'âge moyen (MeSH)</term><term>Association thérapeutique (méthodes)</term><term>Compléments alimentaires (MeSH)</term><term>Femelle (MeSH)</term><term>Humains (MeSH)</term><term>Mitochondries (effets des médicaments et des substances chimiques)</term><term>Mâle (MeSH)</term><term>Méthode en double aveugle (MeSH)</term><term>Résultat thérapeutique (MeSH)</term><term>Trouble bipolaire (traitement médicamenteux)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Acetylcysteine</term></keywords><keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Mitochondria</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Bipolar Disorder</term></keywords><keywords scheme="MESH" qualifier="effets des médicaments et des substances chimiques" xml:lang="fr"><term>Mitochondries</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Combined Modality Therapy</term></keywords><keywords scheme="MESH" qualifier="méthodes" xml:lang="fr"><term>Association thérapeutique</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Trouble bipolaire</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Acétylcystéine</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Dietary Supplements</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Compléments alimentaires</term><term>Femelle</term><term>Humains</term><term>Mâle</term><term>Méthode en double aveugle</term><term>Résultat thérapeutique</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b></p><p>A phasic dysregulation of mitochondrial bioenergetics may operate in bipolar disorder, increased in mania and decreased in depression. We aimed to examine efficacy of two add-on treatments in bipolar depression: N-acetylcysteine (NAC) and NAC with a combination of nutraceutical agents that may increase mitochondrial biogenesis.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>A three-arm 16-week, double-blind, randomised, placebo-controlled trial, adjunctive to usual treatment, was conducted. Participants (n = 181) with bipolar disorder and current depressive symptoms were randomised to 2000 mg/day NAC (n = 59), 2000 mg/day NAC with the combination nutraceutical treatment (CT, n = 61), or placebo (n = 61). The primary outcome was change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to week 16. Young Mania Rating Scale, Clinical Global Impression (CGI)-Improvement and CGI-Severity scales, Patient Global Impression scale, Social and Occupational Functioning Assessment Scale (SOFAS), Longitudinal Interval Follow-Up Evaluation - Range of Impaired Functioning Tool (LIFE-RIFT), and Quality of Life Enjoyment, and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) were secondary outcomes.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>One hundred forty-eight participants had post-randomisation data and were analysed (NAC = 52, CT = 47, Placebo = 49). No between-group differences were found for the rate of change between baseline and 16 weeks on any of the clinical and functioning variables. Improvements in MADRS, BDRS, SOFAS, and LIFE-RIFT scores from baseline to the week 20 post-discontinuation visit were significantly greater in the CT group compared to those in the placebo. At week 20, the CGI-I was significantly lower in the CT group versus placebo. Gastrointestinal symptoms were significantly greater in the NAC than in the placebo group.</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b></p><p>These overall negative results, with no significant differences between groups detected at the primary outcome but some positive secondary signals, suggest either delayed benefit of the combination or an improvement of symptoms on withdrawal which warrants further exploration regarding the composition, mechanisms, and application of mitochondrial agents in illnesses characterised by mitochondrial dysfunction.</p></div><div type="abstract" xml:lang="en"><p><b>TRIAL REGISTRATION</b></p><p>ANZCTR ( ACTRN12612000830897 ).</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" IndexingMethod="Curated" Owner="NLM"><PMID Version="1">30678686</PMID><DateCompleted><Year>2019</Year><Month>06</Month><Day>17</Day></DateCompleted><DateRevised><Year>2020</Year><Month>03</Month><Day>09</Day></DateRevised><Article PubModel="Electronic"><Journal><ISSN IssnType="Electronic">1741-7015</ISSN><JournalIssue CitedMedium="Internet"><Volume>17</Volume><Issue>1</Issue><PubDate><Year>2019</Year><Month>01</Month><Day>25</Day></PubDate></JournalIssue><Title>BMC medicine</Title><ISOAbbreviation>BMC Med</ISOAbbreviation></Journal><ArticleTitle>A randomised controlled trial of a mitochondrial therapeutic target for bipolar depression: mitochondrial agents, N-acetylcysteine, and placebo.</ArticleTitle><Pagination><MedlinePgn>18</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1186/s12916-019-1257-1</ELocationID><Abstract><AbstractText Label="BACKGROUND">A phasic dysregulation of mitochondrial bioenergetics may operate in bipolar disorder, increased in mania and decreased in depression. We aimed to examine efficacy of two add-on treatments in bipolar depression: N-acetylcysteine (NAC) and NAC with a combination of nutraceutical agents that may increase mitochondrial biogenesis.</AbstractText><AbstractText Label="METHODS">A three-arm 16-week, double-blind, randomised, placebo-controlled trial, adjunctive to usual treatment, was conducted. Participants (n = 181) with bipolar disorder and current depressive symptoms were randomised to 2000 mg/day NAC (n = 59), 2000 mg/day NAC with the combination nutraceutical treatment (CT, n = 61), or placebo (n = 61). The primary outcome was change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to week 16. Young Mania Rating Scale, Clinical Global Impression (CGI)-Improvement and CGI-Severity scales, Patient Global Impression scale, Social and Occupational Functioning Assessment Scale (SOFAS), Longitudinal Interval Follow-Up Evaluation - Range of Impaired Functioning Tool (LIFE-RIFT), and Quality of Life Enjoyment, and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) were secondary outcomes.</AbstractText><AbstractText Label="RESULTS">One hundred forty-eight participants had post-randomisation data and were analysed (NAC = 52, CT = 47, Placebo = 49). No between-group differences were found for the rate of change between baseline and 16 weeks on any of the clinical and functioning variables. Improvements in MADRS, BDRS, SOFAS, and LIFE-RIFT scores from baseline to the week 20 post-discontinuation visit were significantly greater in the CT group compared to those in the placebo. At week 20, the CGI-I was significantly lower in the CT group versus placebo. Gastrointestinal symptoms were significantly greater in the NAC than in the placebo group.</AbstractText><AbstractText Label="CONCLUSIONS">These overall negative results, with no significant differences between groups detected at the primary outcome but some positive secondary signals, suggest either delayed benefit of the combination or an improvement of symptoms on withdrawal which warrants further exploration regarding the composition, mechanisms, and application of mitochondrial agents in illnesses characterised by mitochondrial dysfunction.</AbstractText><AbstractText Label="TRIAL REGISTRATION">ANZCTR ( ACTRN12612000830897 ).</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Berk</LastName><ForeName>Michael</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>IMPACT Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, P.O. Box 291, Geelong, VIC, Australia. mikebe@barwonhealth.org.au.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Psychiatry, University of Melbourne, Royal Melbourne Hospital, Level 1 North, Main Block, Parkville, VIC, Australia. mikebe@barwonhealth.org.au.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Florey Institute for Neuroscience and Mental Health, University of Melbourne, Kenneth Myer Building, 30 Royal Parade, Parkville, VIC, Australia. mikebe@barwonhealth.org.au.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Orygen, The National Centre of Excellence in Youth Mental Health, 35 Poplar Rd, Parkville, VIC, Australia. mikebe@barwonhealth.org.au.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Turner</LastName><ForeName>Alyna</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>IMPACT Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, P.O. Box 291, Geelong, VIC, Australia.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Psychiatry, University of Melbourne, Royal Melbourne Hospital, Level 1 North, Main Block, Parkville, VIC, Australia.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>School of Medicine and Public Health, Faculty of Health and Medicine, the University of Newcastle, Callaghan, NSW, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Malhi</LastName><ForeName>Gin S</ForeName><Initials>GS</Initials><AffiliationInfo><Affiliation>CADE Clinic, Royal North Shore Hospital, Northern Sydney Local Health District, St Leonards, NSW, Australia.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Academic Department of Psychiatry, Kolling Institute, Northern Sydney Local Health District, St Leonards, NSW, Australia.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>ARCHI, Sydney Medical School Northern, University of Sydney, Sydney, NSW, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ng</LastName><ForeName>Chee H</ForeName><Initials>CH</Initials><AffiliationInfo><Affiliation>Department of Psychiatry, University of Melbourne, the Melbourne Clinic, 130 Church St Richmond, Melbourne, VIC, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Cotton</LastName><ForeName>Susan M</ForeName><Initials>SM</Initials><AffiliationInfo><Affiliation>Orygen, The National Centre of Excellence in Youth Mental Health, 35 Poplar Rd, Parkville, VIC, Australia.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Centre for Youth Mental Health, The University of Melbourne, 35 Poplar Rd, Parkville, VIC, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dodd</LastName><ForeName>Seetal</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>IMPACT Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, P.O. Box 291, Geelong, VIC, Australia.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Psychiatry, University of Melbourne, Royal Melbourne Hospital, Level 1 North, Main Block, Parkville, VIC, Australia.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Centre for Youth Mental Health, The University of Melbourne, 35 Poplar Rd, Parkville, VIC, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Samuni</LastName><ForeName>Yuval</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>IMPACT Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, P.O. Box 291, Geelong, VIC, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Tanious</LastName><ForeName>Michelle</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>CADE Clinic, Royal North Shore Hospital, Northern Sydney Local Health District, St Leonards, NSW, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>McAulay</LastName><ForeName>Claire</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>CADE Clinic, Royal North Shore Hospital, Northern Sydney Local Health District, St Leonards, NSW, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dowling</LastName><ForeName>Nathan</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Department of Psychiatry, University of Melbourne, the Melbourne Clinic, 130 Church St Richmond, Melbourne, VIC, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sarris</LastName><ForeName>Jerome</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Department of Psychiatry, University of Melbourne, the Melbourne Clinic, 130 Church St Richmond, Melbourne, VIC, Australia.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>NICM, School of Health and Science, Western Sydney University, Campbelltown, NSW, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Owen</LastName><ForeName>Lauren</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>School of Psychology, University of Central Lancashire, Preston, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Waterdrinker</LastName><ForeName>Astrid</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Melbourne Health, 300 Grattan St, Melbourne, VIC, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Smith</LastName><ForeName>Deidre</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Department of Psychiatry, University of Melbourne, the Melbourne Clinic, 130 Church St Richmond, Melbourne, VIC, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dean</LastName><ForeName>Olivia M</ForeName><Initials>OM</Initials><AffiliationInfo><Affiliation>IMPACT Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, P.O. Box 291, Geelong, VIC, Australia.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Psychiatry, University of Melbourne, Royal Melbourne Hospital, Level 1 North, Main Block, Parkville, VIC, Australia.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Florey Institute for Neuroscience and Mental Health, University of Melbourne, Kenneth Myer Building, 30 Royal Parade, Parkville, VIC, Australia.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ANZCTR</DataBankName><AccessionNumberList><AccessionNumber>ACTRN12612000830897</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2019</Year><Month>01</Month><Day>25</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>BMC Med</MedlineTA><NlmUniqueID>101190723</NlmUniqueID><ISSNLinking>1741-7015</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>WYQ7N0BPYC</RegistryNumber><NameOfSubstance UI="D000111">Acetylcysteine</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="ErratumIn"><RefSource>BMC Med. 2019 Feb 17;17(1):35</RefSource><PMID Version="1">30771791</PMID></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName UI="D000111" MajorTopicYN="N">Acetylcysteine</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D001714" MajorTopicYN="N">Bipolar Disorder</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D003131" MajorTopicYN="N">Combined Modality Therapy</DescriptorName><QualifierName UI="Q000379" MajorTopicYN="Y">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D019587" MajorTopicYN="Y">Dietary Supplements</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008928" MajorTopicYN="N">Mitochondria</DescriptorName><QualifierName UI="Q000187" MajorTopicYN="Y">drug effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="Y">Adjunctive</Keyword><Keyword MajorTopicYN="Y">Bipolar disorder</Keyword><Keyword MajorTopicYN="Y">Depression</Keyword><Keyword MajorTopicYN="Y">Mitochondria</Keyword><Keyword MajorTopicYN="Y">Nutraceutical</Keyword><Keyword MajorTopicYN="Y">Oxidative stress</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2018</Year><Month>08</Month><Day>14</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2019</Year><Month>01</Month><Day>09</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2019</Year><Month>1</Month><Day>26</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate 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IdType="pubmed">27736051</ArticleId></ArticleIdList></Reference></ReferenceList></PubmedData></pubmed><affiliations><list><country><li>Australie</li><li>Royaume-Uni</li></country><region><li>Nouvelle-Galles du Sud</li><li>Victoria (État)</li></region><settlement><li>Melbourne</li><li>Sydney</li></settlement><orgName><li>Université de Melbourne</li><li>Université de Sydney</li></orgName></list><tree><country name="Australie"><noRegion><name sortKey="Berk, Michael" sort="Berk, Michael" uniqKey="Berk M" first="Michael" last="Berk">Michael Berk</name></noRegion><name sortKey="Berk, Michael" sort="Berk, Michael" uniqKey="Berk M" first="Michael" last="Berk">Michael Berk</name><name sortKey="Berk, Michael" sort="Berk, Michael" uniqKey="Berk M" first="Michael" last="Berk">Michael Berk</name><name sortKey="Berk, Michael" sort="Berk, Michael" uniqKey="Berk M" first="Michael" last="Berk">Michael Berk</name><name sortKey="Cotton, Susan M" sort="Cotton, Susan M" uniqKey="Cotton S" first="Susan M" last="Cotton">Susan M. 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Dean</name><name sortKey="Dodd, Seetal" sort="Dodd, Seetal" uniqKey="Dodd S" first="Seetal" last="Dodd">Seetal Dodd</name><name sortKey="Dodd, Seetal" sort="Dodd, Seetal" uniqKey="Dodd S" first="Seetal" last="Dodd">Seetal Dodd</name><name sortKey="Dodd, Seetal" sort="Dodd, Seetal" uniqKey="Dodd S" first="Seetal" last="Dodd">Seetal Dodd</name><name sortKey="Dowling, Nathan" sort="Dowling, Nathan" uniqKey="Dowling N" first="Nathan" last="Dowling">Nathan Dowling</name><name sortKey="Malhi, Gin S" sort="Malhi, Gin S" uniqKey="Malhi G" first="Gin S" last="Malhi">Gin S. Malhi</name><name sortKey="Malhi, Gin S" sort="Malhi, Gin S" uniqKey="Malhi G" first="Gin S" last="Malhi">Gin S. Malhi</name><name sortKey="Malhi, Gin S" sort="Malhi, Gin S" uniqKey="Malhi G" first="Gin S" last="Malhi">Gin S. 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Ng</name><name sortKey="Samuni, Yuval" sort="Samuni, Yuval" uniqKey="Samuni Y" first="Yuval" last="Samuni">Yuval Samuni</name><name sortKey="Sarris, Jerome" sort="Sarris, Jerome" uniqKey="Sarris J" first="Jerome" last="Sarris">Jerome Sarris</name><name sortKey="Sarris, Jerome" sort="Sarris, Jerome" uniqKey="Sarris J" first="Jerome" last="Sarris">Jerome Sarris</name><name sortKey="Smith, Deidre" sort="Smith, Deidre" uniqKey="Smith D" first="Deidre" last="Smith">Deidre Smith</name><name sortKey="Tanious, Michelle" sort="Tanious, Michelle" uniqKey="Tanious M" first="Michelle" last="Tanious">Michelle Tanious</name><name sortKey="Turner, Alyna" sort="Turner, Alyna" uniqKey="Turner A" first="Alyna" last="Turner">Alyna Turner</name><name sortKey="Turner, Alyna" sort="Turner, Alyna" uniqKey="Turner A" first="Alyna" last="Turner">Alyna Turner</name><name sortKey="Turner, Alyna" sort="Turner, Alyna" uniqKey="Turner A" first="Alyna" last="Turner">Alyna Turner</name><name sortKey="Waterdrinker, Astrid" sort="Waterdrinker, Astrid" uniqKey="Waterdrinker A" first="Astrid" last="Waterdrinker">Astrid Waterdrinker</name></country><country name="Royaume-Uni"><noRegion><name sortKey="Owen, Lauren" sort="Owen, Lauren" uniqKey="Owen L" first="Lauren" last="Owen">Lauren Owen</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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