Effects of levomilnacipran extended-release on major depressive disorder patients with cognitive impairments: post-hoc analysis of a phase III study
Identifieur interne : 000373 ( Main/Exploration ); précédent : 000372; suivant : 000374Effects of levomilnacipran extended-release on major depressive disorder patients with cognitive impairments: post-hoc analysis of a phase III study
Auteurs : Keith A. Wesnes [Royaume-Uni, Australie] ; Carl Gommoll [États-Unis] ; Changzheng Chen [États-Unis] ; Angelo Sambunaris [Géorgie (pays)] ; Roger S. Mcintyre [Canada] ; Philip D. Harvey [États-Unis]Source :
- International Clinical Psychopharmacology [ 0268-1315 ] ; 2016.
Abstract
Performance-based cognitive data were collected using the Cognitive Drug Research System in a study of levomilnacipran extended-release (ER) 40–120 mg/day (NCT01034462) in adults with major depressive disorder. These data were analyzed post-hoc to explore the relationship between cognitive measures, depression symptoms (Montgomery–Åsberg Depression Rating Scale, MADRS), and self-reported psychosocial functioning (Sheehan Disability Scale; SDS). Changes from baseline were analyzed in the intent-to-treat population and subgroups with impaired attention, as indicated by baseline Cognitive Drug Research System scores for Power of Attention and Continuity of Attention. Path analyses evaluated the direct and indirect effects of levomilnacipran ER on SDS total score change. Significantly greater improvements were observed for levomilnacipran ER versus placebo for Power of Attention, Continuity of Attention, MADRS, and SDS score changes; the mean differences were larger in the impaired subgroups than in the overall intent-to-treat population. Path analyses showed that the majority of SDS total score improvement (≥50%) was attributable to an indirect treatment effect through MADRS total score change; some direct effect of levomilnacipran ER on SDS total score improvement was also observed. In adults with major depressive disorder, levomilnacipran ER effectively improved measures of depression and cognition, which contributed toward reductions in self-reported functional impairment.
Url:
DOI: 10.1097/YIC.0000000000000157
PubMed: 27861191
PubMed Central: 5265686
Affiliations:
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Mcintyre</name><affiliation wicri:level="1"><nlm:aff id="aff7">Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, Ontario, Canada</nlm:aff><country xml:lang="fr">Canada</country><wicri:regionArea>Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, Ontario</wicri:regionArea><wicri:noRegion>Ontario</wicri:noRegion></affiliation></author><author><name sortKey="Harvey, Philip D" sort="Harvey, Philip D" uniqKey="Harvey P" first="Philip D." last="Harvey">Philip D. Harvey</name><affiliation wicri:level="2"><nlm:aff id="aff6">Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, Florida, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, Florida</wicri:regionArea><placeName><region type="state">Floride</region></placeName></affiliation></author></analytic><series><title level="j">International Clinical Psychopharmacology</title><idno type="ISSN">0268-1315</idno><idno type="eISSN">1473-5857</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>Performance-based cognitive data were collected using the Cognitive Drug Research System in a study of levomilnacipran extended-release (ER) 40–120 mg/day (NCT01034462) in adults with major depressive disorder. These data were analyzed post-hoc to explore the relationship between cognitive measures, depression symptoms (Montgomery–Åsberg Depression Rating Scale, MADRS), and self-reported psychosocial functioning (Sheehan Disability Scale; SDS). Changes from baseline were analyzed in the intent-to-treat population and subgroups with impaired attention, as indicated by baseline Cognitive Drug Research System scores for Power of Attention and Continuity of Attention. Path analyses evaluated the direct and indirect effects of levomilnacipran ER on SDS total score change. Significantly greater improvements were observed for levomilnacipran ER versus placebo for Power of Attention, Continuity of Attention, MADRS, and SDS score changes; the mean differences were larger in the impaired subgroups than in the overall intent-to-treat population. Path analyses showed that the majority of SDS total score improvement (≥50%) was attributable to an indirect treatment effect through MADRS total score change; some direct effect of levomilnacipran ER on SDS total score improvement was also observed. In adults with major depressive disorder, levomilnacipran ER effectively improved measures of depression and cognition, which contributed toward reductions in self-reported functional impairment.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Al Sukhni, M" uniqKey="Al Sukhni M">M Al-Sukhni</name></author><author><name sortKey="Maruschak, Na" uniqKey="Maruschak N">NA Maruschak</name></author><author><name sortKey="Mcintyre, Rs" uniqKey="Mcintyre R">RS Mcintyre</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Baune, Bt" uniqKey="Baune B">BT Baune</name></author><author><name sortKey="Renger, L" uniqKey="Renger L">L Renger</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Baune, Bt" uniqKey="Baune B">BT Baune</name></author><author><name sortKey="Miller, R" uniqKey="Miller R">R Miller</name></author><author><name sortKey="Mcafoose, J" 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Harvey</name></country><country name="Géorgie (pays)"><noRegion><name sortKey="Sambunaris, Angelo" sort="Sambunaris, Angelo" uniqKey="Sambunaris A" first="Angelo" last="Sambunaris">Angelo Sambunaris</name></noRegion></country><country name="Canada"><noRegion><name sortKey="Mcintyre, Roger S" sort="Mcintyre, Roger S" uniqKey="Mcintyre R" first="Roger S." last="Mcintyre">Roger S. Mcintyre</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Canada/explor/ParkinsonCanadaV1/Data/Main/Exploration
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 000373 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd -nk 000373 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Wicri/Canada
|area= ParkinsonCanadaV1
|flux= Main
|étape= Exploration
|type= RBID
|clé= PMC:5265686
|texte= Effects of levomilnacipran extended-release on major depressive disorder patients with cognitive impairments: post-hoc analysis of a phase III study
}}
Pour générer des pages wiki
HfdIndexSelect -h $EXPLOR_AREA/Data/Main/Exploration/RBID.i -Sk "pubmed:27861191" \
| HfdSelect -Kh $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd \
| NlmPubMed2Wicri -a ParkinsonCanadaV1
| This area was generated with Dilib version V0.6.29. |  |