Research
IM Olanzapine vs IM Loranzepam vs IM Placebo

Investigator: Philip G. Janicak, M.D.

This is a randomized, double-blind study of inpatients meeting diagnostic criteria for bipolar I disorder and currently displaying an acute manic or mixed episode. The objectives of this study are to assess the efficacy of IM Olanzapine compared with IM placebo in improving severity of agitation, the response rates and time to response. In addition, the study will compare the efficacy of IM Olanzapine to IM lorazepam at 24 hours post-first IM injection , to compare the safety of IM Olanzapine to IM placebo and IM lorazepam through 24 hours. Patients may receive up to three injections thourhgout the entire study. After each injection, patients behavior will be assessed by study personnel and a series of questions will be asked of the patient. The total duration of the study is approximately 28 hours.