A randomized, double-blind, placebo-controlled trial to assess prevention of mood episodes with risperidone long-acting injectable in patients with bipolar I disorder

Apr 17, 2012European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology

Risperidone long-acting injection may help prevent mood episodes in bipolar I disorder: a controlled clinical trial

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Abstract

Risperidone long-acting injectable significantly delayed the time to recurrence of elevated mood episodes compared to placebo.

Patients on risperidone LAI did not reach a median time to mood episode recurrence, while the placebo arm had a median of 198 days.
The time to recurrence of any mood episode was significantly longer for risperidone LAI than for placebo (p=0.031).
Risperidone LAI showed significant improvements in manic symptoms and overall condition compared to placebo.
No evidence was found for worsening of depressive symptoms in patients treated with risperidone LAI.

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The efficacy and safety of risperidone long-acting injectable (LAI) for preventing recurrence of mood episodes in patients with bipolar I disorder was evaluated in a randomized, placebo-controlled study. After a 12-week open-label period with risperidone LAI (n=560), patients who did not experience a recurrence entered an 18-month randomized, double-blind period with risperidone LAI (n=132) or placebo (n=135); a third treatment arm (n=131) was randomized to oral olanzapine (10 mg/day) for reference and exploratory comparisons. The primary efficacy endpoint was time to recurrence of any mood episode for risperidone LAI versus placebo in the double-blind period (Kaplan-Meier analysis). Additional efficacy endpoints included Young Mania Rating Scale, Montgomery-Asberg Depression Rating Scale and Clinical Global Impression. During the double-blind period, dosing was fixed at patients' final open-label dose (25 mg, 66% of patients; 37.5 mg, 31%; 50 mg, 4%). The primary outcome demonstrated a median time to mood episode recurrence of 198 day in the placebo arm, whereas the median was not reached in the risperidone LAI arm (p=0.057). Time to recurrence of any mood episode was significantly longer with risperidone LAI versus placebo (log-rank test stratified by region only, p=0.031); the difference was significant for time to recurrence of elevated mood episodes (p=0.005) but not depressive episodes (p=0.655). Significant improvement of manic symptoms and global condition versus placebo were observed for risperidone LAI, with no evidence of worsening of depression. In conclusion, risperidone LAI significantly delayed time to recurrence of elevated mood episodes, with a safety profile consistent with previous studies.

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A randomized, double-blind, placebo-controlled trial to assess prevention of mood episodes with risperidone long-acting injectable in patients with bipolar I disorder

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