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...
Date First Received: September 13, 2005
Last Updated: December 5, 2007
Verified by: University Hospitals of Cleveland, December 2007
Clinical Trial Phase: Phase 3 | Start Date: July 2002
Overall Status: Terminated
Brief Summary
Official Title: “Pilot Study Evaluating the Safety and Efficacy of Open-Label Olanzapine Monotherapy in Treatment Refractory Bipolar Disorder Mania”
Condition Keyword(s):
Intervention(s):
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
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment
Intervention(s) in this Clinical Trial
- Drug: Olanzapine
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- The subject satisfied 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.
- The subject has not be 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 druh (other than nicotine or caffeine) in the last three (3) months.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 16 Years
Maximum Age for this Clinical Trial: 65 Years
Clinical Trial Sponsor Information
Lead Sponsor: University Hospitals of Cleveland
Overall Clinical Trial Officials and Contacts
Joseph R Calabrese, MD Principal Investigator Case Western Reserve University / University Hospitals of Cleveland
Additional Information
Information obtained from ClinicalTrials.gov on August 28, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00194064
Study ID Number: F1DMC-X136
ClinicalTrials.gov Identifier: NCT00194064
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
