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Agomelatine or placebo as adjunctive therapy to a mood stabiliser in bipolar I depression: randomised double-blind placebo-controlled trial.
- Source :
-
The British journal of psychiatry : the journal of mental science [Br J Psychiatry] 2016 Jan; Vol. 208 (1), pp. 78-86. Date of Electronic Publication: 2015 May 21. - Publication Year :
- 2016
-
Abstract
- Background: Adjunctive antidepressant therapy is commonly used to treat acute bipolar depression but few studies have examined this strategy.<br />Aims: To examine the efficacy of agomelatine v. placebo as adjuncts to lithium or valproate in bipolar depression.<br />Method: Patients who were currently depressed despite taking lithium or valproate for at least 6 weeks were randomised to treatment with agomelatine (n = 172) or placebo (n = 172) for 8 weeks of acute therapy and 44 weeks of continuation therapy (trial registration: ISRCTN28588282).<br />Results: No significant differences in improvement of depressive symptoms were observed between the two groups either at 8 weeks or 52 weeks on the primary efficacy measure of change in Montgomery-Åsberg Depression Rating Scale scores from baseline to end-point. Adverse events including switches into mania/hypomania were low and similar in both groups.<br />Conclusions: Agomelatine adjunctive therapy was not superior to placebo adjunctive therapy for acute bipolar depression.<br /> (© The Royal College of Psychiatrists 2016.)
- Subjects :
- Acetamides adverse effects
Adult
Antidepressive Agents adverse effects
Antimanic Agents therapeutic use
Argentina
Australia
Bipolar Disorder diagnosis
Brazil
Canada
Double-Blind Method
Drug Therapy, Combination
Europe
Female
Humans
India
International Cooperation
Lithium Compounds therapeutic use
Male
Middle Aged
Psychiatric Status Rating Scales
Republic of Korea
South Africa
Treatment Outcome
Valproic Acid therapeutic use
Acetamides administration & dosage
Antidepressive Agents administration & dosage
Bipolar Disorder drug therapy
Placebo Effect
Subjects
Details
- Language :
- English
- ISSN :
- 1472-1465
- Volume :
- 208
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- The British journal of psychiatry : the journal of mental science
- Publication Type :
- Academic Journal
- Accession number :
- 25999335
- Full Text :
- https://doi.org/10.1192/bjp.bp.114.147587