Status:
TERMINATED
Pilot Study Evaluating the Safety and Efficacy of Open-Label Olanzapine
Lead Sponsor:
University Hospitals Cleveland Medical Center
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
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 Disor...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00194064
Start Date
July 1 2002
End Date
February 1 2006
Last Update
October 4 2016
Active Locations (1)
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1
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44140