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Risperidone monotherapy in manic inpatients: an open label, multicentre trial.
Anna Forsthoff1, Heinz Grunze, Florian Seemüller
1Department of Psychiatry, Ludwig-Maximilians-University, Munich, Germany.
Summary
This study shows risperidone monotherapy is effective for severe manic inpatients, mirroring controlled trial results. The treatment demonstrated good tolerability and safety in this real-world clinical setting.
Area of Science:
- Psychiatry
- Pharmacology
Background:
- Controlled studies establish risperidone efficacy in acute mania.
- Real-world clinical effectiveness may differ due to patient population variations in controlled trials.
Purpose of the Study:
- To evaluate risperidone monotherapy's clinical effectiveness in severe manic inpatients.
- To assess risperidone's efficacy and safety in an admission ward setting.
Main Methods:
- Open-label, 3-week monotherapy with risperidone in 30 inpatients.
- Utilized Young Mania Rating Scale (YMRS) and Clinical Global Impression, bipolar version (CGI-BP) for evaluations.
- Documented benzodiazepine use and analyzed data using last observation carried forward.
Main Results:
- Significant improvements observed in YMRS and CGI-BP scores from baseline to exit.
- Two-thirds of patients achieved a 50% reduction in YMRS scores.
- 69% of patients showed marked improvement on the CGI-BP mania scale; low dropout rate due to adverse events.
Conclusions:
- Risperidone monotherapy effectively replicated controlled study efficacy in severely manic inpatients.
- The treatment demonstrated satisfactory tolerability and safety at a mean maximal dosage of 5.5 mg.
- Findings support risperidone's use in acute mania management within inpatient settings.
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