ASPOFAFF :: Journal - Volume 1 :: Issue 2 :: Vol 1 - Iss 2 - Short Communication - Bipolar Disorder: 6-months efficacy of Risperidone Injectable


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ASPOFAFF :: Journal - Volume 1 :: Issue 2 :: Vol 1 - Iss 2 - Short Communication - Bipolar Disorder: 6-months efficacy of Risperidone Injectable

Vol 1 - Iss 2 - Short Communication - Bipolar Disorder: 6-months efficacy of Risperidone Injectable #21

Bipolar Disorder: 6-months efficacy of Risperidone Injectable Rossella Medori1, Peter Bräunig2, Emilio Sacchetti3. 1Janssen-Cilag, Medical Affairs EMEA, Beerse, Belgium 2 Klinikum Chemnitz GmbH, Chemnitz, Germany 3 Clinica Psichiatrica, Spedali Civili di Brescia, BRESCIA, ITALY Objective: To evaluate the 6 month efficacy and tolerability in stable patients with bipolar disorder who were changed directly to Risperidone long-acting injectable (RLAI) from previous treatment. Methods: Adult patients with a bipolar I disorder (DSM IV) who had been stable on their previous unchanged medication(s) regimen for ≥ 1 month, but who were considered to require a treatment change by their physician. Patients received injections of RLAI 25 mg i.m. every 14 days for 6 months. Dosage could be increased to 37.5 mg or 50 mg, if required. Results: Sixteen patients (50% male; mean age 47 years) with a DSM-IV diagnosis of bipolar disorder were directly transitioned because of non-compliance (50%), side effects (19%), insufficient efficacy (25%) and/or other reasons (12%). Twelve patients completed the six months treatment with RLAI. Three patients discontinued the study early due to withdrawal of consent and one due to adverse events. Dose distribution at baseline was 62.5%, 25% and 12.5% for 25, 37.5 and 50 mg which shifted to 46.7%, 13.3% and 40% at endpoint. This group demonstrated a clinically significant reduction in disease symptoms according to CGI (Disease Severity) at endpoint compared to baseline. The patients classified as ‘not ill/borderline ill’ increased from 3 patients at baseline to 6 patients at endpoint and those “markedly ill/moderately ill” decreased from 8 to 4. Patients improved their symptoms control in all PANSS subscales and PANSS symptom factors (according to Marder et al.1), in addition the scores for PANSS-P (according to Marder et al. 1) showed a significant reduction from baseline to endpoint (p<0.05). Mean GAF score improved 3.9 points to 69.6 at endpoint compared to baseline and patient satisfaction with treatment was significantly increased at endpoint compared to baseline (p<0.05). The proportion of patients rating their satisfaction with treatment as ‘very good’ increased from 0% at baseline to 36% at endpoint. Mean ESRS total score improved slightly from baseline to endpoint. There were no unexpected side effects, and the majority of adverse events were of mild or moderate severity. Conclusion: This cohort of patients with bipolar disorder who were stable on other regimens showed a slight improvement in Total PANSS over a six month treatment period with Risperidone long-acting injectable. None of the patients discontinued due to manic or depressive episodes. This treatment was associated with improved global functioning and patient satisfaction as well as good tolerability. The study offers preliminary data on maintenance treatment in patients with bipolar disorder with risperidone long-acting injectable. References: 1. Marder SR, Davis JM, Chouinard G. The effects of risperidone on the five dimensions of schizophrenia derived by factor analysis: combined results of the North American trials. J Clin Psychiatry 1997; 58: 538-546.

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