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Trial of Olanzapine in Patients With Manic or Mixed Episode of Bipolar I Disorder | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

Placebo- and Haloperidol-Controlled Double-Blind Trial of Olanzapine in Patients With Manic or Mixed Episode of Bipolar I Disorder

NCT00129220•Eli Lilly and Company

View on ClinicalTrials.gov

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.

Eligibility

Age

20 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Meet the criteria for manic or mixed episodes according to the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) and have a diagnosis of "294.4x Bipolar I Disorder, Most Recent Episode Manic" or "296.6x Bipolar I Disorder, Most Recent Episode Mixed".
•Have a total score on the Young Mania Rating Scale (YMRS) of at least 20 at Visit 1 and Visit 2.

Exclusion Criteria

•Have received an antidepressant or a psychostimulant within 5 days prior to Visit 1.
•The duration of the current episode is more than 90 days at Visit 1.
•Have a history or a diagnosis of diabetes mellitus.
•Have received any psychotropic medication within 2 days prior to Visit 2 (except for benzodiazepines).

Locations (16)

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.

Aichi, Japan

Akita, Japan

Chiba, Japan

Fukuoka, Japan

Gunma, Japan

Hokkaido, Japan

Hyōgo, Japan

Kanagawa, Japan

Kumamoto, Japan

Nagano, Japan

Key Dates

Start Date

July 1, 2005

Primary Completion Date

January 1, 2009

Completion Date

January 1, 2009

Last Updated

December 28, 2010

Enrollment

224

ACTUAL participants

Conditions

Bipolar Disorder

Interventions

olanzapine

DRUG

haloperidol

DRUG

placebo

DRUG

University of Iowa Interventional Psychiatry Service Patient Registry

NCT04480918

Treatment Resistant DepressionMajor Depressive Episode+5 more

View study

RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

NCT07140913

ManiaBipolar Disorder

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 28, 2010Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

University of Iowa Interventional Psychiatry Service Patient Registry

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

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