The world journal of biological psychiatry : the official journal of the World Federation of Societies of Biological Psychiatry · 2007
Risperidone monotherapy in manic inpatients: an open label, multicentre trial.
Клиническое исследованиеСтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Forsthoff Anna, Grunze Heinz, Seemüller Florian, Stampfer Robert, Dittmann Sandra, Amann Bendikt, Schmidt Folkhart, Schäfer Martin, Hermle Leo, Walden Jörg, Schreiner Andreas
Аннотация
OBJECTIVE: The efficacy of risperidone in acute mania has been established in several controlled clinical studies. However, this may not necessarily resemble the clinical effectiveness of this treatment, as patient populations in controlled studies are considered as being not representative. This study examined risperidone monotherapy in a sample of severe manic patients in admission ward settings.
METHODS: Open label monotherapy with risperidone was examined for 3 weeks in 30 inpatients. Subjects were evaluated with structured clinical rating scales: Young Mania Rating Scale (YMRS), Clinical Global Impression, bipolar version (CGI-BP), and the Extrapyramidal Symptom Rating Scale (ESRS). In addition, the amount of concomitant use of benzodiazepines was documented. Data were analysed using a last observation carried forward method on all subjects given medication at baseline.
RESULTS: Significant improvement from baseline to exit was observed both for the YMRS and CGI-BP. Responder analysis revealed that two-thirds of the patients showed a reduction of 50% in the YMRS score, and 69% of the patients were rated as very much improved or much improved on the CGI-BP mania scale at study exit. Only three patients dropped out due to adverse events, in one case due to extrapyramidal symptoms.
CONCLUSIONS: The efficacy of risperidone in the acute treatment of mania as observed in controlled studies could be replicated in this open monotherapy study in a severely manic inpatient population. Considering the mean maximal dosage of 5.5+/-0.9 mg risperidone, the tolerability and safety profile appeared satisfactory.
METHODS: Open label monotherapy with risperidone was examined for 3 weeks in 30 inpatients. Subjects were evaluated with structured clinical rating scales: Young Mania Rating Scale (YMRS), Clinical Global Impression, bipolar version (CGI-BP), and the Extrapyramidal Symptom Rating Scale (ESRS). In addition, the amount of concomitant use of benzodiazepines was documented. Data were analysed using a last observation carried forward method on all subjects given medication at baseline.
RESULTS: Significant improvement from baseline to exit was observed both for the YMRS and CGI-BP. Responder analysis revealed that two-thirds of the patients showed a reduction of 50% in the YMRS score, and 69% of the patients were rated as very much improved or much improved on the CGI-BP mania scale at study exit. Only three patients dropped out due to adverse events, in one case due to extrapyramidal symptoms.
CONCLUSIONS: The efficacy of risperidone in the acute treatment of mania as observed in controlled studies could be replicated in this open monotherapy study in a severely manic inpatient population. Considering the mean maximal dosage of 5.5+/-0.9 mg risperidone, the tolerability and safety profile appeared satisfactory.