Trial record 27 of 40 for:
CARBAMAZEPINE AND Valproic Acid
Pilot Study Evaluating the Safety and Efficacy of Open-Label Olanzapine
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| ClinicalTrials.gov Identifier: NCT00194064 |
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Recruitment Status :
Terminated
(Slow enrollment)
First Posted : September 19, 2005
Last Update Posted : October 4, 2016
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Sponsor:
University Hospitals Cleveland Medical Center
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Joseph Calabrese, MD, University Hospitals Cleveland Medical Center
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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 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bipolar Disorder | Drug: Olanzapine | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 18 participants |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Pilot Study Evaluating the Safety and Efficacy of Open-Label Olanzapine Monotherapy in Treatment Refractory Bipolar Disorder Mania |
| Study Start Date : | July 2002 |
| Actual Primary Completion Date : | February 2006 |
| Actual Study Completion Date : | February 2006 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Bipolar disorder
MedlinePlus related topics:
Bipolar Disorder
| Arm | Intervention/treatment |
|---|---|
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Experimental: Olanzapine
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
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Drug: Olanzapine
Other Name: Zyprexa |
Primary Outcome Measures :
- Young Mania Rating Scale (YMRS) [ Time Frame: Change from Baseline to End of Study ]
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 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 drug (other than nicotine or caffeine) in the last three (3) months.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00194064
Locations
| United States, Ohio | |
| University Hospitals of Cleveland | |
| Cleveland, Ohio, United States, 44140 | |
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Eli Lilly and Company
Investigators
| Principal Investigator: | Joseph R Calabrese, MD | Case Western Reserve University / University Hospitals of Cleveland |
| Responsible Party: | Joseph Calabrese, MD, Director, Mood Disorders Program, University Hospitals Cleveland Medical Center |
| ClinicalTrials.gov Identifier: | NCT00194064 History of Changes |
| Other Study ID Numbers: |
F1DMC-X136 |
| First Posted: | September 19, 2005 Key Record Dates |
| Last Update Posted: | October 4, 2016 |
| Last Verified: | October 2016 |
Additional relevant MeSH terms:
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Bipolar Disorder Bipolar and Related Disorders Mental Disorders Olanzapine Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Antipsychotic Agents |
Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents |