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

NCT ID: NCT00194064

Last Updated: 2016-10-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-07-31
• Study Completion Date: 2006-02-28

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.

Conditions

Bipolar Disorder

Study Design

• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Olanzapine

Intervention Type: DRUG

Interventions

Olanzapine

Intervention Type: DRUG

Other Intervention Names

Zyprexa

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Joseph Calabrese, MD

Director, Mood Disorders Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joseph R Calabrese, MD

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University / University Hospitals of Cleveland

Locations

University Hospitals of Cleveland

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

F1DMC-X136

Identifier Type: -

Identifier Source: org_study_id