PoplarV1, Main, Exploration, bibRecord, 002017

The addition of fluoxetine to cognitive behavioural therapy for youth depression (YoDA-C): study protocol for a randomised control trial.

Identifieur interne : 002017 ( Main/Exploration ); précédent : 002016; suivant : 002018

The addition of fluoxetine to cognitive behavioural therapy for youth depression (YoDA-C): study protocol for a randomised control trial.

Auteurs : Christopher G. Davey [Australie] ; Andrew M. Chanen ; Sue M. Cotton ; Sarah E. Hetrick ; Melissa J. Kerr ; Michael Berk ; Olivia M. Dean ; Kally Yuen ; Mark Phelan ; Aswin Ratheesh ; Miriam R. Sch Fer ; G Paul Amminger ; Alexandra G. Parker ; Danijela Piskulic ; Susy Harrigan ; Andrew J. Mackinnon ; Ben J. Harrison ; Patrick D. Mcgorry

Source :

Trials [ 1745-6215 ] ; 2014.

RBID : pubmed:25370185

Descripteurs français

KwdFr :
- Adolescent (MeSH), Adulte (MeSH), Antidépresseurs de seconde génération (effets indésirables), Antidépresseurs de seconde génération (usage thérapeutique), Association thérapeutique (MeSH), Comportement de l'adolescent (effets des médicaments et des substances chimiques), Facteurs temps (MeSH), Facteurs âges (MeSH), Femelle (MeSH), Fluoxétine (effets indésirables), Fluoxétine (usage thérapeutique), Humains (MeSH), Inhibiteurs de la capture de la sérotonine (effets indésirables), Inhibiteurs de la capture de la sérotonine (usage thérapeutique), Jeune adulte (MeSH), Mâle (MeSH), Méthode en double aveugle (MeSH), Plan de recherche (MeSH), Protocoles cliniques (MeSH), Qualité de vie (MeSH), Résultat thérapeutique (MeSH), Thérapie cognitive (MeSH), Trouble dépressif majeur (diagnostic), Trouble dépressif majeur (psychologie), Trouble dépressif majeur (thérapie), Valeur prédictive des tests (MeSH), Victoria (MeSH), Échelles d'évaluation en psychiatrie (MeSH).
MESH :
- diagnostic : Trouble dépressif majeur.
- effets des médicaments et des substances chimiques : Comportement de l'adolescent.
- effets indésirables : Antidépresseurs de seconde génération, Fluoxétine, Inhibiteurs de la capture de la sérotonine.
- psychologie : Trouble dépressif majeur.
- thérapie : Trouble dépressif majeur.
- usage thérapeutique : Antidépresseurs de seconde génération, Fluoxétine, Inhibiteurs de la capture de la sérotonine.
- Adolescent, Adulte, Association thérapeutique, Facteurs temps, Facteurs âges, Femelle, Humains, Jeune adulte, Mâle, Méthode en double aveugle, Plan de recherche, Protocoles cliniques, Qualité de vie, Résultat thérapeutique, Thérapie cognitive, Valeur prédictive des tests, Victoria, Échelles d'évaluation en psychiatrie.

English descriptors

KwdEn :
- Adolescent (MeSH), Adolescent Behavior (drug effects), Adult (MeSH), Age Factors (MeSH), Antidepressive Agents, Second-Generation (adverse effects), Antidepressive Agents, Second-Generation (therapeutic use), Clinical Protocols (MeSH), Cognitive Behavioral Therapy (MeSH), Combined Modality Therapy (MeSH), Depressive Disorder, Major (diagnosis), Depressive Disorder, Major (psychology), Depressive Disorder, Major (therapy), Double-Blind Method (MeSH), Female (MeSH), Fluoxetine (adverse effects), Fluoxetine (therapeutic use), Humans (MeSH), Male (MeSH), Predictive Value of Tests (MeSH), Psychiatric Status Rating Scales (MeSH), Quality of Life (MeSH), Research Design (MeSH), Serotonin Uptake Inhibitors (adverse effects), Serotonin Uptake Inhibitors (therapeutic use), Time Factors (MeSH), Treatment Outcome (MeSH), Victoria (MeSH), Young Adult (MeSH).
MESH :
- chemical , adverse effects : Antidepressive Agents, Second-Generation, Fluoxetine, Serotonin Uptake Inhibitors.
- diagnosis : Depressive Disorder, Major.
- drug effects : Adolescent Behavior.
- psychology : Depressive Disorder, Major.
- chemical , therapeutic use : Antidepressive Agents, Second-Generation, Fluoxetine, Serotonin Uptake Inhibitors.
- therapy : Depressive Disorder, Major.
- Adolescent, Adult, Age Factors, Clinical Protocols, Cognitive Behavioral Therapy, Combined Modality Therapy, Double-Blind Method, Female, Humans, Male, Predictive Value of Tests, Psychiatric Status Rating Scales, Quality of Life, Research Design, Time Factors, Treatment Outcome, Victoria, Young Adult.

Abstract

BACKGROUND

The aim of the Youth Depression Alleviation-Combined Treatment (YoDA-C) study is to determine whether antidepressant medication should be started as a first-line treatment for youth depression delivered concurrently with psychotherapy. Doubts about the use of medication have been raised by meta-analyses in which the efficacy and safety of antidepressants in young people have been questioned, and subsequent treatment guidelines for youth depression have provided only qualified support.

METHODS/DESIGN

YoDA-C is a double-blind, randomised controlled trial funded by the Australian government's National Health and Medical Research Council. Participants between the ages of 15 and 25 years with moderate to severe major depressive disorder will be randomised to receive either (1) cognitive behavioural therapy (CBT) and fluoxetine or (2) CBT and placebo. The treatment duration will be 12 weeks, and follow-up will be conducted at 26 weeks. The primary outcome measure is change in the Montgomery-Åsberg Depression Rating Scale (MADRS) after 12 weeks of treatment. The MADRS will be administered at baseline and at weeks 4, 8, 12 and 26. Secondary outcome measures will address additional clinical outcomes, functioning, quality of life and safety.

TRIAL REGISTRATION

Australian and New Zealand Clinical Trials Registry ID: ACTRN12612001281886 (registered on 11 December 2012).

DOI: 10.1186/1745-6215-15-425
PubMed: 25370185
PubMed Central: PMC4230740

Affiliations:

Australie

Links toward previous steps (curation, corpus...)

to stream Main, to step Corpus: 001F41
to stream Main, to step Curation: 001F41

Le document en format XML

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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adolescent (MeSH)</term>
<term>Adolescent Behavior (drug effects)</term>
<term>Adult (MeSH)</term>
<term>Age Factors (MeSH)</term>
<term>Antidepressive Agents, Second-Generation (adverse effects)</term>
<term>Antidepressive Agents, Second-Generation (therapeutic use)</term>
<term>Clinical Protocols (MeSH)</term>
<term>Cognitive Behavioral Therapy (MeSH)</term>
<term>Combined Modality Therapy (MeSH)</term>
<term>Depressive Disorder, Major (diagnosis)</term>
<term>Depressive Disorder, Major (psychology)</term>
<term>Depressive Disorder, Major (therapy)</term>
<term>Double-Blind Method (MeSH)</term>
<term>Female (MeSH)</term>
<term>Fluoxetine (adverse effects)</term>
<term>Fluoxetine (therapeutic use)</term>
<term>Humans (MeSH)</term>
<term>Male (MeSH)</term>
<term>Predictive Value of Tests (MeSH)</term>
<term>Psychiatric Status Rating Scales (MeSH)</term>
<term>Quality of Life (MeSH)</term>
<term>Research Design (MeSH)</term>
<term>Serotonin Uptake Inhibitors (adverse effects)</term>
<term>Serotonin Uptake Inhibitors (therapeutic use)</term>
<term>Time Factors (MeSH)</term>
<term>Treatment Outcome (MeSH)</term>
<term>Victoria (MeSH)</term>
<term>Young Adult (MeSH)</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Adolescent (MeSH)</term>
<term>Adulte (MeSH)</term>
<term>Antidépresseurs de seconde génération (effets indésirables)</term>
<term>Antidépresseurs de seconde génération (usage thérapeutique)</term>
<term>Association thérapeutique (MeSH)</term>
<term>Comportement de l'adolescent (effets des médicaments et des substances chimiques)</term>
<term>Facteurs temps (MeSH)</term>
<term>Facteurs âges (MeSH)</term>
<term>Femelle (MeSH)</term>
<term>Fluoxétine (effets indésirables)</term>
<term>Fluoxétine (usage thérapeutique)</term>
<term>Humains (MeSH)</term>
<term>Inhibiteurs de la capture de la sérotonine (effets indésirables)</term>
<term>Inhibiteurs de la capture de la sérotonine (usage thérapeutique)</term>
<term>Jeune adulte (MeSH)</term>
<term>Mâle (MeSH)</term>
<term>Méthode en double aveugle (MeSH)</term>
<term>Plan de recherche (MeSH)</term>
<term>Protocoles cliniques (MeSH)</term>
<term>Qualité de vie (MeSH)</term>
<term>Résultat thérapeutique (MeSH)</term>
<term>Thérapie cognitive (MeSH)</term>
<term>Trouble dépressif majeur (diagnostic)</term>
<term>Trouble dépressif majeur (psychologie)</term>
<term>Trouble dépressif majeur (thérapie)</term>
<term>Valeur prédictive des tests (MeSH)</term>
<term>Victoria (MeSH)</term>
<term>Échelles d'évaluation en psychiatrie (MeSH)</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antidepressive Agents, Second-Generation</term>
<term>Fluoxetine</term>
<term>Serotonin Uptake Inhibitors</term>
</keywords>
<keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Depressive Disorder, Major</term>
</keywords>
<keywords scheme="MESH" qualifier="diagnostic" xml:lang="fr"><term>Trouble dépressif majeur</term>
</keywords>
<keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Adolescent Behavior</term>
</keywords>
<keywords scheme="MESH" qualifier="effets des médicaments et des substances chimiques" xml:lang="fr"><term>Comportement de l'adolescent</term>
</keywords>
<keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Antidépresseurs de seconde génération</term>
<term>Fluoxétine</term>
<term>Inhibiteurs de la capture de la sérotonine</term>
</keywords>
<keywords scheme="MESH" qualifier="psychologie" xml:lang="fr"><term>Trouble dépressif majeur</term>
</keywords>
<keywords scheme="MESH" qualifier="psychology" xml:lang="en"><term>Depressive Disorder, Major</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antidepressive Agents, Second-Generation</term>
<term>Fluoxetine</term>
<term>Serotonin Uptake Inhibitors</term>
</keywords>
<keywords scheme="MESH" qualifier="therapy" xml:lang="en"><term>Depressive Disorder, Major</term>
</keywords>
<keywords scheme="MESH" qualifier="thérapie" xml:lang="fr"><term>Trouble dépressif majeur</term>
</keywords>
<keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Antidépresseurs de seconde génération</term>
<term>Fluoxétine</term>
<term>Inhibiteurs de la capture de la sérotonine</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adolescent</term>
<term>Adult</term>
<term>Age Factors</term>
<term>Clinical Protocols</term>
<term>Cognitive Behavioral Therapy</term>
<term>Combined Modality Therapy</term>
<term>Double-Blind Method</term>
<term>Female</term>
<term>Humans</term>
<term>Male</term>
<term>Predictive Value of Tests</term>
<term>Psychiatric Status Rating Scales</term>
<term>Quality of Life</term>
<term>Research Design</term>
<term>Time Factors</term>
<term>Treatment Outcome</term>
<term>Victoria</term>
<term>Young Adult</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Adolescent</term>
<term>Adulte</term>
<term>Association thérapeutique</term>
<term>Facteurs temps</term>
<term>Facteurs âges</term>
<term>Femelle</term>
<term>Humains</term>
<term>Jeune adulte</term>
<term>Mâle</term>
<term>Méthode en double aveugle</term>
<term>Plan de recherche</term>
<term>Protocoles cliniques</term>
<term>Qualité de vie</term>
<term>Résultat thérapeutique</term>
<term>Thérapie cognitive</term>
<term>Valeur prédictive des tests</term>
<term>Victoria</term>
<term>Échelles d'évaluation en psychiatrie</term>
</keywords>
</textClass>
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<front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b>
</p>
<p>The aim of the Youth Depression Alleviation-Combined Treatment (YoDA-C) study is to determine whether antidepressant medication should be started as a first-line treatment for youth depression delivered concurrently with psychotherapy. Doubts about the use of medication have been raised by meta-analyses in which the efficacy and safety of antidepressants in young people have been questioned, and subsequent treatment guidelines for youth depression have provided only qualified support.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>METHODS/DESIGN</b>
</p>
<p>YoDA-C is a double-blind, randomised controlled trial funded by the Australian government's National Health and Medical Research Council. Participants between the ages of 15 and 25 years with moderate to severe major depressive disorder will be randomised to receive either (1) cognitive behavioural therapy (CBT) and fluoxetine or (2) CBT and placebo. The treatment duration will be 12 weeks, and follow-up will be conducted at 26 weeks. The primary outcome measure is change in the Montgomery-Åsberg Depression Rating Scale (MADRS) after 12 weeks of treatment. The MADRS will be administered at baseline and at weeks 4, 8, 12 and 26. Secondary outcome measures will address additional clinical outcomes, functioning, quality of life and safety.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>TRIAL REGISTRATION</b>
</p>
<p>Australian and New Zealand Clinical Trials Registry ID: ACTRN12612001281886 (registered on 11 December 2012).</p>
</div>
</front>
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<DateCompleted><Year>2015</Year>
<Month>07</Month>
<Day>08</Day>
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<DateRevised><Year>2018</Year>
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<Day>02</Day>
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<Month>Nov</Month>
<Day>04</Day>
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<Title>Trials</Title>
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<ArticleTitle>The addition of fluoxetine to cognitive behavioural therapy for youth depression (YoDA-C): study protocol for a randomised control trial.</ArticleTitle>
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<ELocationID EIdType="doi" ValidYN="Y">10.1186/1745-6215-15-425</ELocationID>
<Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">The aim of the Youth Depression Alleviation-Combined Treatment (YoDA-C) study is to determine whether antidepressant medication should be started as a first-line treatment for youth depression delivered concurrently with psychotherapy. Doubts about the use of medication have been raised by meta-analyses in which the efficacy and safety of antidepressants in young people have been questioned, and subsequent treatment guidelines for youth depression have provided only qualified support.</AbstractText>
<AbstractText Label="METHODS/DESIGN" NlmCategory="METHODS">YoDA-C is a double-blind, randomised controlled trial funded by the Australian government's National Health and Medical Research Council. Participants between the ages of 15 and 25 years with moderate to severe major depressive disorder will be randomised to receive either (1) cognitive behavioural therapy (CBT) and fluoxetine or (2) CBT and placebo. The treatment duration will be 12 weeks, and follow-up will be conducted at 26 weeks. The primary outcome measure is change in the Montgomery-Åsberg Depression Rating Scale (MADRS) after 12 weeks of treatment. The MADRS will be administered at baseline and at weeks 4, 8, 12 and 26. Secondary outcome measures will address additional clinical outcomes, functioning, quality of life and safety.</AbstractText>
<AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND">Australian and New Zealand Clinical Trials Registry ID: ACTRN12612001281886 (registered on 11 December 2012).</AbstractText>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Davey</LastName>
<ForeName>Christopher G</ForeName>
<Initials>CG</Initials>
<AffiliationInfo><Affiliation>Orygen, The National Centre of Excellence in Youth Mental Health, 35 Poplar Road, Parkville, VIC 3052, Australia. c.davey@unimelb.edu.au.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Chanen</LastName>
<ForeName>Andrew M</ForeName>
<Initials>AM</Initials>
</Author>
<Author ValidYN="Y"><LastName>Cotton</LastName>
<ForeName>Sue M</ForeName>
<Initials>SM</Initials>
</Author>
<Author ValidYN="Y"><LastName>Hetrick</LastName>
<ForeName>Sarah E</ForeName>
<Initials>SE</Initials>
</Author>
<Author ValidYN="Y"><LastName>Kerr</LastName>
<ForeName>Melissa J</ForeName>
<Initials>MJ</Initials>
</Author>
<Author ValidYN="Y"><LastName>Berk</LastName>
<ForeName>Michael</ForeName>
<Initials>M</Initials>
</Author>
<Author ValidYN="Y"><LastName>Dean</LastName>
<ForeName>Olivia M</ForeName>
<Initials>OM</Initials>
</Author>
<Author ValidYN="Y"><LastName>Yuen</LastName>
<ForeName>Kally</ForeName>
<Initials>K</Initials>
</Author>
<Author ValidYN="Y"><LastName>Phelan</LastName>
<ForeName>Mark</ForeName>
<Initials>M</Initials>
</Author>
<Author ValidYN="Y"><LastName>Ratheesh</LastName>
<ForeName>Aswin</ForeName>
<Initials>A</Initials>
</Author>
<Author ValidYN="Y"><LastName>Schäfer</LastName>
<ForeName>Miriam R</ForeName>
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The addition of fluoxetine to cognitive behavioural therapy for youth depression (YoDA-C): study protocol for a randomised control trial.

The addition of fluoxetine to cognitive behavioural therapy for youth depression (YoDA-C): study protocol for a randomised control trial.

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