Context: The risk of relapse and disability of Bipolar Disorder increases with multiple episodes. Treatment trials in first episode populations offer an optimal opportunity to study a homogeneous cohort with an early intervention strategy. Additionally, here are currently no clear treatment guidelines for first episode mania. While atypical neuroleptics seem to offer advantages compared to typical neuroleptics, they nevertheless also have side effects.
Aims: Comparison of efficacy, safety and tolerability of chlorpromazine and olanzapine, both in combination with lithium, in the treatment of a first manic episode with psychotic features.
Methods: Individuals presenting to EPPIC were randomised to either a combination of olanzapine and lithium or chlorpromazine and lithium in the treatment of a first episode of psychotic mania. The duration of the acute phase of the trial was 8 weeks, and there is an 18 month follow up period. Outcome measures include the Young Mania Rating Scale, Clinical Global Impression, Global Assessment of Functioning Scale and the Social and Occupational Functioning Assessment Scale. A total of 75 subjects, between the age of 16 and 30 consented to the trial. They were randomised to either olanzapine is started at 5 mg per day or chlorpromazine, started at 100 mg per day, with doses titrated according to need. All individuals were on concurrent treatment with lithium, serum levels between 0.8 and 1.0.
Results: Primary and secondary outcome measures of the trial will be presented.