Abstract
This study aimed to assess the safety, tolerability, efficacy, and compliance of a risperidone long-acting injection (RLAI) formulation for the maintenance treatment of stabilized bipolar patients. A prospective, open-label trial of RLAI was conducted for 12 months. Stable bipolar patients (n = 11) were switched from their existing oral antipsychotic agents to RLAI, and injections were given every 2 weeks. The assessments were performed at baseline and at 6 and 12 months of treatment by using the Young Mania Rating Scale (YMRS), Clinical Global Impressions-Severity of Illness (CGI-S) scale, 17-item Hamilton Rating Scale for Depression (HAM-D), Brief Psychiatric Rating Scale (BPRS), and Extrapyramidal Symptom Rating Scale (ESRS). The satisfaction levels of subjects were evaluated at the end of the study period using a 10-point visual analog scale. Ten patients (90.9%) completed the trial, and no significant changes were seen in the YMRS, HAM-D, and BPRS scores throughout the study. CGI-S and ESRS scores were significantly decreased from the baseline to the post-12-month treatment score. Relapses were not reported by any of the participants. This result indicates that RLAI may be beneficial in the maintenance therapy of stable bipolar patients; however, an adequately powered, randomized, placebo-controlled trial is necessary to draw a definite conclusion about the role of RLAI in the maintenance treatment of bipolar patients.
Original language | English |
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Pages (from-to) | 1219-1223 |
Number of pages | 5 |
Journal | Progress in Neuro-Psychopharmacology and Biological Psychiatry |
Volume | 31 |
Issue number | 6 |
DOIs | |
Publication status | Published - 2007 Aug 15 |
Externally published | Yes |
Bibliographical note
Funding Information:Dr. Han has received research support from Korea Research Foundation Grant (MOEHRD) (KRF-2007-013-E00033); was on the speakers' bureau of Janssen, Otsuka, and MSD. Dr. Pae has received research support from GlaxoSmithKline. Dr. Patkar is a consultant for Bristol-Myers Squibb, GlaxoSmithKline, and Reckitt Benckiser; is on the speaker's bureau of Bristol-Myers Squibb, GlaxoSmithKline, and Reckitt Benckiser; has received research support from National Institutes of Health, AstraZeneca, Bristol-Myers Squibb, Forest, GlaxoSmithKline, Janssen, McNeil Consumer and Specialty Inc, Organon, Jazz Pharmaceuticals, and Pfizer. Janssen supplied the study medication.
Keywords
- Bipolar disorder
- Long-acting injections
- Maintenance
- Risperidone
ASJC Scopus subject areas
- Pharmacology
- Biological Psychiatry