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P03-359 Randomized, Double-Blind, Placebo-Controlled Study of Risperidone Long-Acting Injectable in Relapse Prevention in Patients with Bipolar I Disorder

Published online by Cambridge University Press:  17 April 2020

S. Montgomery ,
E. Vieta ,
A.H. Sulaiman ,
R. Cordoba ,
B. Huberlant ,
A. Schreiner  and
G. Martinez
S. Montgomery
Affiliation:
Imperial College School of Medicine, University of London, London, UK
E. Vieta
Affiliation:
Bipolar Disorders Program, Hospital Clinic, University of Barcelona, IDIBAPS, CIBERSAM, Barcelona, Spain
A.H. Sulaiman
Affiliation:
Department of Psychological Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia
R. Cordoba
Affiliation:
Centro Campo Abierto OSI, University El Rosario, Centro de Investigaciones del Sistema Nervioso - GRUPO CISNE, Bogota, Colombia
B. Huberlant
Affiliation:
SGS Life Sciences Services, Medical Affairs, Mechelen, Belgium
A. Schreiner
Affiliation:
Janssen-Cilag Medical Affairs EMEA, Neuss, Germany
G. Martinez
Affiliation:
Janssen-Cilag Medical Affairs EMEA, Madrid, Spain

Abstract

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Objectives

To evaluate risperidone long-acting injectable (RLAI) versus placebo in prevention of mood episodes in adults with bipolar I disorder.

Methods

A 12-week open-label period with RLAI (N=585) was followed by an 18-month randomized, double-blind period with RLAI (25, 37.5 or 50 mg/2 weeks; N=137) or placebo (N=140); a third group (N=138) was randomized to olanzapine for reference and exploratory comparisons. Primary efficacy endpoint: time to relapse of any mood episode for risperidone LAI vs. placebo in the double-blind period (Kaplan-Meier analysis). Relapse was defined by criteria including DSM diagnosis, further treatment, hospitalisation, or Clinical Global Impression score ≥4 combined with YMRS or MADRS >12.

Results

Dosing was fixed during the double-blind period at patients’ final open-label dose (25 mg, 66%; 37.5 mg, 31%; 50 mg, 4%). Time to recurrence (any mood episode) was longer with RLAI versus placebo (log-rank test stratified by region and patient type, p=0.062; stratified by region only, p=0.032); the difference was significant for time to recurrence of elevated mood episodes (p=0.005) but not depressive episodes (p=0.587). Discontinuations due to adverse events (AEs) occurred in 2% of patients in the open-label period, and 4% and 1% in the RLAI and placebo groups, respectively, in the double-blind period. The most frequently reported AE in the open-label period was insomnia (15%). During double-blind treatment, the most frequently reported AEs with RLAI were weight increased (24%; placebo, 9%) and insomnia (16%; placebo, 17%).

Table 1.Type of recurrence

Type of episode, n (%)Risperidone LAI (N=135)Placebo (N=138)
All mood episodes52 (38.5)77 (55.8)
Elevated mood episode27 (20.0)54(39.1)
Hypomanic2(1.5)4 (2.9)
Manic17(12.6)43(31.2)
Mixed8 (5.9)7(5.1)
Depressive25(18.5)23(16.7)

Conclusion

RLAI significantly delayed time to relapse of elevated mood episodes and was well tolerated.

Type
Psychopharmacological treatment and biological therapies
Information
European Psychiatry , Volume 25 , Issue S1: 18th European Congress of Psychiatry. February 27, March 2, 2010 - Munich, Germany , 2010 , 25-E965
Copyright
Copyright © European Psychiatric Association 2010
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