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Sponsors and Collaborators: |
University Hospitals of Cleveland Eli Lilly and Company |
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Information provided by: | University Hospitals of Cleveland |
ClinicalTrials.gov Identifier: | NCT00194064 |
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 | Intervention | Phase |
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Bipolar Disorder |
Drug: Olanzapine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment |
Official Title: | Pilot Study Evaluating the Safety and Efficacy of Open-Label Olanzapine Monotherapy in Treatment Refractory Bipolar Disorder Mania |
Ages Eligible for Study: | 16 Years to 65 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
United States, Ohio | |
University Hospitals of Cleveland | |
Cleveland, Ohio, United States, 44140 |
Principal Investigator: | Joseph R Calabrese, MD | Case Western Reserve University / University Hospitals of Cleveland |
Responsible Party: | University Hospitals/Case Western Reserve Unviersity ( Joseph R. Calabrese ) |
Study ID Numbers: | F1DMC-X136 |
Study First Received: | September 13, 2005 |
Last Updated: | December 5, 2007 |
ClinicalTrials.gov Identifier: | NCT00194064 History of Changes |
Health Authority: | United States: Institutional Review Board |
Neurotransmitter Agents Tranquilizing Agents Bipolar Disorder Olanzapine Psychotropic Drugs Antiemetics Central Nervous System Depressants Antipsychotic Agents |
Serotonin Uptake Inhibitors Serotonin Affective Disorders, Psychotic Mental Disorders Mood Disorders Psychotic Disorders Peripheral Nervous System Agents |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Disease Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Bipolar Disorder Physiological Effects of Drugs Gastrointestinal Agents Psychotropic Drugs Olanzapine Antiemetics Central Nervous System Depressants |
Antipsychotic Agents Serotonin Uptake Inhibitors Pharmacologic Actions Affective Disorders, Psychotic Serotonin Agents Pathologic Processes Autonomic Agents Mental Disorders Therapeutic Uses Mood Disorders Peripheral Nervous System Agents Central Nervous System Agents |