Pilot Study Evaluating the Safety and Efficacy of Open-Label Olanzapine Monotherapy in Treatment Refractory Bipolar Disorder Mania
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...
Brief Summary
Official Title: “Pilot Study Evaluating the Safety and Efficacy of Open-Label Olanzapine Monotherapy in Treatment Refractory Bipolar Disorder Mania”
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: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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 Investigator Information
Lead Investigator: University Hospitals of Cleveland Other
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 February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00194064
