Status:
TERMINATED
A Study in the Treatment of Acute Mania
Lead Sponsor:
Eli Lilly and Company
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to test the efficacy and total costs of olanzapine versus commonly used conventional antipsychotics in Sweden.
Detailed Description
The primary objective is to show that the efficacy of olanzapine is non-inferior to the conventional antipsychotics haloperidol or zuclopentixol in the treatment of an acute manic or mixed episode of ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00767715
Start Date
October 1 2004
End Date
April 1 2005
Last Update
October 7 2008
Active Locations (1)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Danderyd, Sweden