- Paul E Keck Jr, professor of psychiatry, pharmacology, and neuroscience (Paul.Keck@UC.edu)
- Psychopharmacology Research Program, Department of Psychiatry, University of Cincinnati College of Medicine, 231 Albert Sabin Way, PO Box 670559, Cincinnati, OH 45267-0559, USA
Encouraging results from clinical trials need to be replicated in practice
Bipolar disorder is a common, severe psychiatric disorder that is characterised by recurrent manic, mixed, and depressive episodes. Cognitive, behavioural, and psychotic symptoms often occur during mood episodes, and suicide rates in bipolar disorder are among the highest of all psychiatric illnesses.1 Acute bipolar manic and mixed episodes often constitute medical emergencies, requiring admission to hospital to ensure safety and rapid recovery. However, morbidity from mania is not limited to acute episodes as full recovery of functioning often lags months behind remission of symptoms.2 Medications form the cornerstone of treatment of mania, and in the past decade randomised controlled trials of new medications for this syndrome have proliferated. These studies have addressed important questions about the short term efficacy and tolerability of new agents, alone and in combination.
The efficacy of agents for the treatment of acute mania has typically been established in three to four week, placebo controlled, randomised, parallel group, monotherapy trials in patients admitted to hospital without clinically significant medical or psychiatric comorbidity who are able to give informed consent. These …