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

Phase 3TerminatedNCT00194064

University Hospitals Cleveland Medical Center18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bipolar Disorder

Interventions

OlanzapineDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Young Mania Rating Scale (YMRS)

Time frame: Change from Baseline to End of Study

Data from ClinicalTrials.gov

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