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

Stopped early · Phase 3

Conditions studied: Bipolar Disorder

In brief

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.

Key facts

Study ID: NCT00194064
Run by: University Hospitals Cleveland Medical Center
People needed: 18
Starts: 2002-07-01
Expected to finish: 2006-02-01
Last updated by the study team: 2016-10-04

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

University Hospitals of Cleveland — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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