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
  Purpose

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: 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:

Primary Outcome Measures:
  • Young Mania Rating Scale (YMRS) [ Time Frame: Change from Baseline to End of Study ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: July 2002
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Olanzapine
Other Name: Zyprexa

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.
  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 ClinicalTrials.gov identifier: NCT00194064

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

No publications provided

Responsible Party: Joseph Calabrese, MD, Director, Mood Disorders Program, University Hospital Case Medical Center
ClinicalTrials.gov Identifier: NCT00194064     History of Changes
Other Study ID Numbers: F1DMC-X136
Study First Received: September 13, 2005
Last Updated: December 1, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Olanzapine
Antiemetics
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

ClinicalTrials.gov processed this record on September 02, 2015