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

Phase 3

Terminated

• Conditions: Bipolar Disorder
• Interventions: Drug: Olanzapine

• Registration Number: NCT00194064
• Lead Sponsor: University Hospitals Cleveland Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-07
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-19
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-03
• Last Update Posted: 2016-10-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Olanzapine	Olanzapine	Subjects were be started on a standardized minimum first-day dose of 15 mg olanzapine. After the first day of therapy, the daily dose was either increased or decreased, as clinically indicated, by 5 mg, within an allowed range of 5 to 40 mg

Primary Outcome Measures

Name	Time	Method
Young Mania Rating Scale (YMRS)	Change from Baseline to End of Study

Trial Locations

Locations (1)

University Hospitals of Cleveland; 🇺🇸 Cleveland, Ohio, United States