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

University Hospitals (UH)

Status and phase: Terminated; Phase 3

Conditions: Bipolar Disorder

Treatments: Drug: Olanzapine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00194064

F1DMC-X136

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

18 participants in 1 patient group

Olanzapine

Experimental group

Description:

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

Treatment:

Drug: Olanzapine