Human psychopharmacology · 2004
Acute and continuation risperidone monotherapy in mania.
Клиническое исследованиеСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Vieta Eduard, Brugué Esteve, Goikolea José Manuel, Sánchez-Moreno Jose, Reinares María, Comes Mercè, Colom Francesc, Martínez-Arán Anabel, Benabarre Antoni, Torrent Carla
Аннотация
BACKGROUND: The aim of this study was to assess the effectiveness and safety of risperidone monotherapy for acute and continuation treatment of mania.
METHOD: Ninety-six DSM-IV acutely manic bipolar patients with a Young mania rating score (YMRS) of 20 or more entered this open, multicentre, 6-month study. Efficacy was assessed with the YMRS, the positive and negative syndrome scale (PANSS) and the clinical global impressions scale (CGI). Safety was assessed with the UKU side effect rating scale and with the Hamilton depression rating scale, for the assessment of a switch to depression.
RESULTS: 80 patients (83.3%) completed the study. Using the last-observation-carried-forward analysis, risperidone produced highly significant improvements (p<0.0001) on the all efficacy measures from weeks 1 (YMRS) and 4 (PANSS and CGI) onwards, for a 6-month period. There was a significant increase in extrapyramidal side-effects by week 4 (p=0.015) and a significant decrease at the 6-month endpoint (p=0.027). Risperidone did not induce depressive symptoms, as mean HDRS scores actually improved (p<0.0001), and exacerbation of mania was rare (n=4, 4.2%). The mean dose of risperidone was 4.2 mg/day.
CONCLUSION: Monotherapy with risperidone is effective and well tolerated in acute and continuation treatment of mania. The results should be confirmed in randomized, double-blind clinical trials.
METHOD: Ninety-six DSM-IV acutely manic bipolar patients with a Young mania rating score (YMRS) of 20 or more entered this open, multicentre, 6-month study. Efficacy was assessed with the YMRS, the positive and negative syndrome scale (PANSS) and the clinical global impressions scale (CGI). Safety was assessed with the UKU side effect rating scale and with the Hamilton depression rating scale, for the assessment of a switch to depression.
RESULTS: 80 patients (83.3%) completed the study. Using the last-observation-carried-forward analysis, risperidone produced highly significant improvements (p<0.0001) on the all efficacy measures from weeks 1 (YMRS) and 4 (PANSS and CGI) onwards, for a 6-month period. There was a significant increase in extrapyramidal side-effects by week 4 (p=0.015) and a significant decrease at the 6-month endpoint (p=0.027). Risperidone did not induce depressive symptoms, as mean HDRS scores actually improved (p<0.0001), and exacerbation of mania was rare (n=4, 4.2%). The mean dose of risperidone was 4.2 mg/day.
CONCLUSION: Monotherapy with risperidone is effective and well tolerated in acute and continuation treatment of mania. The results should be confirmed in randomized, double-blind clinical trials.