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Pilot Study Evaluating the Safety and Efficacy of Open-Label Olanzapine

This study has been terminated.
(Slow enrollment)
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Joseph Calabrese, MD, University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT00194064
First received: September 13, 2005
Last updated: December 1, 2014
Last verified: December 2014

September 13, 2005
December 1, 2014
July 2002
February 2006   (final data collection date for primary outcome measure)
Young Mania Rating Scale (YMRS) [ Time Frame: Change from Baseline to End of Study ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00194064 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pilot Study Evaluating the Safety and Efficacy of Open-Label Olanzapine
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.

Not Provided
Interventional
Phase 3
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Bipolar Disorder
Drug: Olanzapine
Other Name: Zyprexa
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
Intervention: Drug: Olanzapine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
18
February 2006
February 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00194064
F1DMC-X136
Yes
Joseph Calabrese, MD, University Hospital Case Medical Center
University Hospital Case Medical Center
Eli Lilly and Company
Principal Investigator: Joseph R Calabrese, MD Case Western Reserve University / University Hospitals of Cleveland
University Hospital Case Medical Center
December 2014

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