Low-Dose Adjunctive Aripiprazole in the Treatment of Bipolar Depression: Double-Blind Placebo-Controlled Pilot Study
|ClinicalTrials.gov Identifier: NCT01520350|
Recruitment Status : Terminated (recruitment issues)
First Posted : January 27, 2012
Last Update Posted : July 29, 2014
Aripiprazole is a new antipsychotic agent which possesses unique capabilities compared to other antipsychotic agents, especially because of its partial dopaminergic agonistic activity. Moreover, like the other atypical agents, aripiprazole is an antagonist of the 5-HT2a receptor, and an agonist of the 5-HT1a receptor. These pharmacological properties should enable this molecule to provide antidepressant potentiating capabilities based on what has been observed with other compounds sharing similar pharmacological profiles.
Aripiprazole is now well recognized for its capacity to potentiate antidepressants in the treatment of unipolar depression. However, two randomized controlled trials of aripiprazole in the treatment of bipolar depression were negative. This surprising result may stem from the fact that the doses of aripiprazole used in these studies were rather high (17.6 ± 8.3 mg/d in study 1 and 15.5 ± 7.5 mg/d in study 2) and could have contributed to inhibit dopaminergic activity in key brain areas involved in the modulation of rewards, motivation and concentration. Bipolar depression is indeed heavily loaded with general symptoms of psychomotor retardation including poor concentration, low energy level, hypersomnolence, and hyperphagia. All these functions are modulated by dopamine and strategies aimed at improving dopaminergic function are used frequently to resolve residual symptoms of bipolar depression.
It is expected that aripiprazole used at a more adequate lower dose than in previous studies, should be efficacious in the treatment of bipolar type I depression.
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder Depressive Episode||Drug: Low dose Adjunctive Aripiprazole Drug: placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Low-Dose Adjunctive Aripiprazole in the Treatment of Bipolar Depression: Double-Blind Placebo-Controlled Pilot Study|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
|Experimental: Mood stabilizer + Aripiprazole||
Drug: Low dose Adjunctive Aripiprazole
low-dose 2-5mg/d for 8 weeks
Other Name: Abilify
|Placebo Comparator: Mood stabilizer + placebo||
- Response rate [ Time Frame: 8 weeks ]The primary outcome measure will be the response rate as defined by a differential reduction of 5 points on the Montgomery Asberg rating Scale (MADRS) between the active treatment group and the placebo group at 8 weeks of treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01520350
|Douglas Mental Health University Institute|
|Montréal, Quebec, Canada, H4H 1R3|
|Principal Investigator:||Serge Beaulieu, MD, PhD||Douglas Institute|