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Pilot Study Evaluating the Safety and Efficacy of Open-Label Olanzapine | Clinical Trials | Clareo Health

TERMINATEDPHASE3

Pilot Study Evaluating the Safety and Efficacy of Open-Label Olanzapine

Pilot Study Evaluating the Safety and Efficacy of Open-Label Olanzapine Monotherapy in Treatment Refractory Bipolar Disorder Mania

NCT00194064•University Hospitals Cleveland Medical Center

View on ClinicalTrials.gov

Summary

Inpatient Study Evaluating the Safety and Efficacy of Open-Label Olanzapine Monotherapy in Treatment Refractory Bipolar Mania: This study recruits adult subjects who are diagnosed with Bipolar I Disorder and presently experiencing an episode of mania. Patients must be willing to spend initial 7 days in the hospital to observe response to medication. Patients must be refractory (intolerant or non-responsive) to treatment with lithium and valproate or carbamazepine. Patients receive study-related care at no cost. This study is sponsored by Eli Lilly and Company.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•The subject satisfied Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for a primary diagnosis of Bipolar Disorder, most recently manic
•The patient is willing to be hospitalized on an inpatient psychiatric unit for a minimum of seven (7) days.
•Subject has been treated with lithium in the past.
•Subject has been treated with divalproex or carbamazepine in the past.
•Subject has been treated with Haldol or haloperidol in the past.

Exclusion Criteria

•Subjects lacks the capacity to provide informed consent
•Subject is a serious suicide risk or has medically unstable conditions as judged by the investigators
•Subject has been dependent on a drug (other than nicotine or caffeine) in the last three (3) months.

Locations (1)

University Hospitals of Cleveland

Cleveland, Ohio, United States

Key Dates

Start Date

July 1, 2002

Primary Completion Date

February 1, 2006

Completion Date

February 1, 2006

Last Updated

October 4, 2016

Enrollment

ACTUAL participants

Conditions

Bipolar Disorder

Interventions

Olanzapine

DRUG

University of Iowa Interventional Psychiatry Service Patient Registry

NCT04480918

Treatment Resistant DepressionMajor Depressive Episode+5 more

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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: October 4, 2016Data 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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Pilot Study Evaluating the Safety and Efficacy of Open-Label Olanzapine

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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