A Study in the Treatment of Acute Mania

• Status: Terminated
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to test the efficacy and total costs of olanzapine versus commonly used conventional antipsychotics in Sweden.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Haloperidol; Haloperidol decanoate; Olanzapine

Criteria

Inclusion Criteria:

• Diagnosis of bipolar I disorder and currently display an acute manic or mixed episode (with or without psychotic features)

• Patients must have a Y-MRS total score of greater or equal to 20 at visit 2

• Patients must have experienced at least one manic or mixed episode prior to study enrollment

• Female of childbearing potential must be using a medically accepted means of contraception, or practice sexual abstinence

• Each patient must have a level of understanding sufficient to communicate intelligently with study personnel

• Patients must be considered reliable

• Each patient must understand the nature of the study and signed informed consent

Exclusion Criteria:

• Female patients who are pregnant or lactating

• Serious, unstable illnesses such that hospitalization for the disease is anticipated within 3 month or death is anticipated within 3 years

• Uncorrected hypothyroidism or hyperthyroidism

• Narrow-angle glaucoma

• History of allergic reactions or intolerance to study medications

• DSM-IV substance dependence within the past 30 days at the judgement of the investigator

• Judged clinically to be at serious suicidal risk

• Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections prior to visit 2

• Any patient treated with clozapine within 4 weeks prior to visit 2

• Subjects who have received treatment with ECT within one month prior to visit 1