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Trial of Olanzapine in Patients With Manic or Mixed Episode of Bipolar I Disorder

NCT00129220 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2010-12-28

Study results available
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Summary

The purpose of this study is to confirm the efficacy of olanzapine in the treatment of manic or mixed symptoms associated with bipolar I disorder.

Conditions

Interventions

DRUG

olanzapine

5-20 mg, oral, once daily (evening), for 6 weeks

DRUG

haloperidol

2.5-10 mg, oral, twice daily (morning and evening), for 6 weeks.

DRUG

placebo

placebo, oral tablets, twice daily (morning and evening), for 3 weeks

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Monday-Friday 9am-5pm Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00129220 on ClinicalTrials.gov