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

This study has been terminated.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT00194064
First received: September 13, 2005
Last updated: December 5, 2007
Last verified: December 2007

September 13, 2005
December 5, 2007
July 2002
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Complete list of historical versions of study NCT00194064 on ClinicalTrials.gov Archive Site
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Pilot Study Evaluating the Safety and Efficacy of Open-Label Olanzapine Monotherapy in Treatment Refractory Bipolar Disorder Mania
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.

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Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Bipolar Disorder
Drug: Olanzapine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
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February 2007
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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.
Both
16 Years to 65 Years
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Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00194064
F1DMC-X136
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Joseph R. Calabrese, University Hospitals/Case Western Reserve Unviersity
University Hospitals of Cleveland
Eli Lilly and Company
Principal Investigator: Joseph R Calabrese, MD Case Western Reserve University / University Hospitals of Cleveland
University Hospitals of Cleveland
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP