Pilot Study Evaluating the Safety and Efficacy of Open-Label Olanzapine
This study has been terminated.
Eli Lilly and Company
Information provided by (Responsible Party):
Joseph Calabrese, MD, University Hospital Case Medical Center
First received: September 13, 2005
Last updated: December 1, 2014
Last verified: December 2014
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.
||Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||Pilot Study Evaluating the Safety and Efficacy of Open-Label Olanzapine Monotherapy in Treatment Refractory Bipolar Disorder Mania
Primary Outcome Measures:
- Young Mania Rating Scale (YMRS) [ Time Frame: Change from Baseline to End of Study ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||February 2006 (Final data collection date for primary outcome measure)
Subjects were be started on a standardized minimum first-day dose of 15 mg olanzapine. After the first day of therapy, the daily dose was either increased or decreased, as clinically indicated, by 5 mg, within an allowed range of 5 to 40 mg
Other Name: Zyprexa
|Ages Eligible for Study:
||18 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00194064
|University Hospitals of Cleveland
|Cleveland, Ohio, United States, 44140 |
University Hospital Case Medical Center
Eli Lilly and Company
||Joseph R Calabrese, MD
||Case Western Reserve University / University Hospitals of Cleveland
No publications provided
||Joseph Calabrese, MD, Director, Mood Disorders Program, University Hospital Case Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 13, 2005
||December 1, 2014
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 16, 2015
Affective Disorders, Psychotic
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Physiological Effects of Drugs
Serotonin Uptake Inhibitors