Background
Treatment adherence is a significant problem in patients with bipolar disorder. This
study was designed to determine the efficacy of risperidone long-acting injectable
(LAI) in the maintenance treatment of bipolar I disorder.
Methods
Eligible patients with current or recent manic or mixed episodes (n = 559, aged 18–65 years) were treated with open-label oral risperidone for 3 weeks
(period II) and open-label risperidone LAI for 26 weeks (n = 501; period III). Patients who maintained response (n = 303) were randomly allocated 1:1 to placebo injections (n = 149) or to continue risperidone LAI (n = 154) for up to 24 months (period IV).
Results
Most (77%) patients on risperidone LAI received a dose of 25 mg every 2 weeks during
period IV. Time to recurrence for any mood episode (primary outcome variable) was
significantly longer in the risperidone LAI group versus placebo (p < .001); the difference was significant for time to recurrence of elevated-mood episode
(p < .001) but not time to recurrence of depressive episode (p = .805). Weight gains ≥7% (compared with the period's baseline) occurred in 15% of
patients in period III; in 12% of patients on risperidone LAI and 3% of patients on
placebo in period IV.
Conclusions
Risperidone LAI monotherapy significantly delayed the time to recurrence of mood episodes,
versus placebo, in this controlled, randomized study in patients with bipolar I disorder.
Risperidone LAI was tolerable and no new safety concerns emerged compared with previous
studies of risperidone LAI.
Key Words
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Article info
Publication history
Published online: March 15, 2010
Accepted:
January 20,
2010
Received in revised form:
January 14,
2010
Received:
August 17,
2009
Footnotes
Vivek Kusumakar is deceased.
Identification
Copyright
© 2010 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.
