Pilot Study Evaluating the Safety and Efficacy of Open-Label Olanzapine Monotherapy in Treatment Refractory Bipolar Disorder Mania
Information source: University Hospitals of Cleveland
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder
Intervention: Olanzapine (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: University Hospitals of Cleveland Official(s) and/or principal investigator(s):
Joseph R Calabrese, MD, Principal Investigator, Affiliation: Case Western Reserve University / University Hospitals of Cleveland
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 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.
Clinical Details
Official title: Pilot Study Evaluating the Safety and Efficacy of Open-Label Olanzapine Monotherapy in Treatment Refractory Bipolar Disorder Mania
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment
Eligibility
Minimum age: 16 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
University Hospitals of Cleveland, Cleveland, Ohio 44140, United States
Additional Information
Starting date: July 2002
Ending date: February 2007
Last updated: December 5, 2007
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