We will assess the effect of olanzapine compared to placebo added to prior treatment on CGI-S
in a one-week randomized double-blind study. We will also assess the effect of olanzapine
added to prior treatment on CGI-S in an eight-week open treatment study. In addition, we will
assess the effect of olanzapine on Young Mania Rating Scale (YMRS), Hamilton and
Montgomery-Asberg Depression Rating Scales (HDRS, and MADRS), and Hamilton Anxiety Rating
Scales (HARS) in the above paradigms. We will also assess the influence of presentation
severity (CGI-S) and polarity (mood elevation versus depression) on olanzapine response.
Finally, we will assess safety and tolerability of olanzapine in the above paradigms.
We hypothesize that in diverse mild syndromal and subsyndromal exacerbations of BD in
outpatients, randomized double-blind flexibly dosed olanzapine added to prior treatment
(including no treatment) will yield greater CGI-S improvement than placebo by the end of one
week, and that such improvement will persist over one week of open continuation treatment.