Support for this study was provided by Ortho-McNeil Janssen Scientific Affairs, LLC, Titusville, NJ, USA. LA, WM, JTH, NT, IT, and CB are full-time employees of Ortho-McNeil Janssen Scientific Affairs, LLC. At the time of this study, MK was a full-time employee of Ortho-McNeil Janssen Scientific Affairs, LLC; she is currently an employee of Hoffman-La Roche, Inc. At the time of this study, RM was a full-time employee of Ortho-McNeil Janssen Scientific Affairs, LLC; he is currently an employee of Ethicon, Inc., a Johnson & Johnson company.
A randomized, double-blind, placebo-controlled study of maintenance treatment with adjunctive risperidone long-acting therapy in patients with bipolar I disorder who relapse frequently
Article first published online: 16 NOV 2009
© 2009 The Authors. Journal compilation © 2009 John Wiley & Sons A/S
Volume 11, Issue 8, pages 827–839, December 2009
How to Cite
Macfadden, W., Alphs, L., Haskins, J. T., Turner, N., Turkoz, I., Bossie, C., Kujawa, M. and Mahmoud, R. (2009), A randomized, double-blind, placebo-controlled study of maintenance treatment with adjunctive risperidone long-acting therapy in patients with bipolar I disorder who relapse frequently. Bipolar Disorders, 11: 827–839. doi: 10.1111/j.1399-5618.2009.00761.x
- Issue published online: 16 NOV 2009
- Article first published online: 16 NOV 2009
- Received 5 December 2008, revised and accepted for publication 1 September 2009
- bipolar disorder;
- long-acting injectable;
Objective: No large controlled trials have evaluated adjunctive maintenance treatment with long-acting injectable antipsychotics in patients with bipolar disorder. This study assessed whether adjunctive maintenance treatment with risperidone long-acting therapy (RLAT), added to treatment-as-usual (TAU) medications for bipolar disorder, delays relapse in patients with bipolar disorder type I.
Methods: This study included patients with bipolar disorder type I with ≥ four mood episodes in the 12 months prior to study entry. Following a 16-week, open-label stabilization phase with RLAT plus TAU, remitted patients entered a 52-week, double-blind, placebo-controlled, relapse-prevention phase. Randomized patients continued treatment with adjunctive RLAT (25–50 mg every two weeks) plus TAU (n = 65) or switched to adjunctive placebo injection plus TAU (n = 59). The primary outcome measure was time to relapse to any mood episode.
Results: Of 240 enrolled patients, 124 entered double-blind treatment. Time to relapse was longer in patients receiving adjunctive RLAT (p = 0.010). Relapse rates were 23.1% (n = 15) with adjunctive RLAT versus 45.8% (n = 27) with adjunctive placebo; relative relapse risk was 2.3-fold higher with adjunctive placebo (p = 0.011). Completion rates were: adjunctive RLAT, 60.0% (n = 39) and adjunctive placebo, 42.4% (n = 25; p = 0.050). Adverse event (AE)-related discontinuations were 4.6% (n = 3) and 1.7% (n = 1), respectively. Common AEs (adjunctive RLAT versus adjunctive placebo) were: tremor (24.6% versus 10.2%), insomnia (20.0% versus 18.6%), muscle rigidity (12.3% versus 5.1%), weight increased (6.2% versus 1.7%), and hypokinesia (7.7% versus 0.0%).
Conclusions: Adjunctive RLAT significantly delayed time to relapse in patients with bipolar disorder type I who relapse frequently. Safety and tolerability of RLAT were generally consistent with that previously observed.