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Pilot Study Evaluating the Safety and Efficacy of Open-Label Olanzapine Monotherapy in Treatment Refractory Bipolar Disorder Mania

This study has been terminated.
Eli Lilly and Company
Information provided by:
University Hospital Case Medical Center Identifier:
First received: September 13, 2005
Last updated: December 5, 2007
Last verified: December 2007

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
Bipolar Disorder
Drug: Olanzapine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by University Hospital Case Medical Center:

Study Start Date: July 2002
Study Completion Date: February 2007

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both

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.
  Contacts and Locations
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 identifier: NCT00194064

United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44140
Sponsors and Collaborators
University Hospital Case Medical Center
Eli Lilly and Company
Principal Investigator: Joseph R Calabrese, MD Case Western Reserve University / University Hospitals of Cleveland
  More Information

No publications provided

Responsible Party: Joseph R. Calabrese, University Hospitals/Case Western Reserve Unviersity Identifier: NCT00194064     History of Changes
Other Study ID Numbers: F1DMC-X136
Study First Received: September 13, 2005
Last Updated: December 5, 2007
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Pathologic Processes
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses
Tranquilizing Agents processed this record on November 25, 2014