Agomelatine or placebo as adjunctive therapy to a mood stabiliser in bipolar I depression: Randomised double-blind placebo-controlled trial
| Autor: | Lakshmi N, Yatham, Eduard, Vieta, Guy M, Goodwin, Michel, Bourin, Christian, de Bodinat, Judith, Laredo, Joseph, Calabrese, L, Yatham |
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| Rok vydání: | 2016 |
| Předmět: |
Adult
Male Canada medicine.medical_specialty Bipolar Disorder Lithium (medication) International Cooperation Argentina Placebo-controlled study India Placebo South Africa 03 medical and health sciences 0302 clinical medicine Double-Blind Method Antimanic Agents Internal medicine Acetamides Republic of Korea medicine Humans Agomelatine Psychiatry Adverse effect Psychiatric Status Rating Scales Valproic Acid Australia Middle Aged Placebo Effect Antidepressive Agents 030227 psychiatry Europe Psychiatry and Mental health Treatment Outcome Hypomania Mood Lithium Compounds Drug Therapy Combination Female medicine.symptom Psychology Mania Brazil 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | British Journal of Psychiatry. 208:78-86 |
| ISSN: | 1472-1465 0007-1250 2858-8282 |
| DOI: | 10.1192/bjp.bp.114.147587 |
| Popis: | BackgroundAdjunctive antidepressant therapy is commonly used to treat acute bipolar depression but few studies have examined this strategy.AimsTo examine the efficacy of agomelatine v. placebo as adjuncts to lithium or valproate in bipolar depression.MethodPatients 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).ResultsNo 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.ConclusionsAgomelatine adjunctive therapy was not superior to placebo adjunctive therapy for acute bipolar depression. |
| Databáze: | OpenAIRE |
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