Cleveland, Ohio 44140

  • Bipolar Disorder

Purpose:

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.


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.


NCT ID:

NCT00194064


Primary Contact:

Principal Investigator
Joseph R Calabrese, MD
Case Western Reserve University / University Hospitals of Cleveland


Backup Contact:

N/A


Location Contact:

Cleveland, Ohio 44140
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 26, 2020

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