A randomized, double-blind, placebo-controlled 26-week trial of aripiprazole in recently manic patients with bipolar I disorder

Psychopharmacology Research Program, Department of Psychiatry, University of Cincinnati College of Medicine, Cincinnati, Ohio 45267, USA.
The Journal of Clinical Psychiatry (Impact Factor: 5.5). 04/2006; 67(4):626-37.
Source: PubMed


To investigate the safety and efficacy of aripiprazole in preventing relapse of a mood episode in recently manic- or mixed-episode patients with bipolar I disorder stabilized on aripiprazole.
This randomized, double-blind, parallel-group, placebo-controlled, multicenter study enrolled patients from 76 centers in 3 countries (Argentina, Mexico, United States) from March 2000 to June 2003. Bipolar I disorder (DSM-IV) patients who had recently been hospitalized and treated for a manic or mixed episode entered an open-label stabilization phase (aripiprazole monotherapy: 15 or 30 mg/day, 6-18 weeks). After meeting stabilization criteria (Young Mania Rating Scale score of < or = 10 and Montgomery-Asberg Depression Rating Scale score of < or = 13 for 6 consecutive weeks), 161 patients were randomly assigned to aripiprazole or placebo for the 26-week, double-blind phase. The primary endpoint was time to relapse for a manic, mixed, or depressive episode (defined by discontinuation caused by lack of efficacy).
Aripiprazole was superior to placebo in delaying the time to relapse (p = .020). Aripiprazole-treated patients had significantly fewer relapses (25%) than placebo patients (43%; p = .013). Aripiprazole was superior to placebo in delaying the time to manic relapse (p = .01); however, no significant differences were observed in time to depressive relapse (p = .68). Weight gain (> or = 7% increase) occurred in 7 (13%) aripiprazole-treated and 0 placebo-treated patients. Adverse events (> or = 5% incidence and twice that of placebo) reported by aripiprazole-treated patients were akathisia, pain in the extremities, tremor, and vaginitis.
Aripiprazole, 15 or 30 mg/day, was superior to placebo in maintaining efficacy in patients with bipolar I disorder with a recent manic or mixed episode who were stabilized and maintained on aripiprazole treatment for 6 weeks, as shown by a longer time to relapse.

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    • "The dose range is from 5 to 20mgs/day. Aripiprazole is effective in preventing manic relapses as monotherapy (Keck et al. 2006) and the response rate is nearly 60% when it is continued for 100 weeks (Keck et al. 2007). The dose range is from 15 to 30mgs/day. "
    Mental Illnesses - Evaluation, Treatments and Implications, 01/2012; , ISBN: 978-953-307-645-4
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    • "L'aripiprazole par contre a montré une efficacité dans la prévention des rechutes maniaques mais pas dans celle des rechutes dépressives [16] [15]. "
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    L Encéphale 12/2011; 37 Suppl 3:S209-13. · 0.70 Impact Factor
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    • "Aripiprazole acts as a partial agonist at the pre-synaptic dopamine autoreceptors and post-synaptic D2 receptors (where it may have a higher intrinsic activity).8,9 This in vitro profile provides for functional antagonism in hyperdopaminergic states and functional agonism in hypodopaminergic states.10 Dehydroaripiprazole, has similar pharmacodynamic effects at the D2 receptors.7 "
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    ABSTRACT: We aimed to review and synthesize results reporting on the maintenance efficacy of Aripiprazole in adults with bipolar I disorder. Aripiprazole is FDA approved for the acute and maintenance treatment of bipolar I disorder. Aripiprazole's efficacy during the long-term treatment of bipolar disorder is supported by extension of acute phase studies and long-term (ie, 100-week) double-blind placebo controlled recurrence prevention registration trials. Aripiprazole is not established as efficacious in the acute or maintenance treatment of bipolar depression. Moreover, aripiprazole's efficacy during the acute or maintenance phase of bipolar II disorder has not been sufficiently studied. Aripiprazole has a relatively lower hazard for metabolic disruption and change in body composition when compared to other atypical agents (eg, olanzapine, quetiapine). Moreover, aripiprazole has minimal propensity for sedation, somnolence and prolactin elevation. Aripiprazole is associated with extrapyramidal side effects, notably akathisia, which in most cases is not severe or treatment limiting. Future research vistas are to explore aripiprazole's efficacy in bipolar subgroups; recurrence prevention of bipolar depression; and in combination with other mood stabilizing agents.
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