TY - JOUR
T1 - Usefulness of long-acting injectable risperidone during 12-month maintenance therapy of bipolar disorder
AU - Han, Changsu
AU - Lee, Moon Soo
AU - Pae, Chi Un
AU - Ko, Young Hoon
AU - Patkar, Ashwin A.
AU - Jung, In Kwa
N1 - 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.
PY - 2007/8/15
Y1 - 2007/8/15
N2 - 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.
AB - 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.
KW - Bipolar disorder
KW - Long-acting injections
KW - Maintenance
KW - Risperidone
UR - http://www.scopus.com/inward/record.url?scp=34447563990&partnerID=8YFLogxK
U2 - 10.1016/j.pnpbp.2007.04.017
DO - 10.1016/j.pnpbp.2007.04.017
M3 - Article
C2 - 17532106
AN - SCOPUS:34447563990
VL - 31
SP - 1219
EP - 1223
JO - Progress in Neuro-Psychopharmacology and Biological Psychiatry
JF - Progress in Neuro-Psychopharmacology and Biological Psychiatry
SN - 0278-5846
IS - 6
ER -