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

This study has been terminated.
(Slow enrollment)
Eli Lilly and Company
Information provided by (Responsible Party):
Joseph Calabrese, MD, University Hospitals Cleveland Medical Center Identifier:
First received: September 13, 2005
Last updated: October 3, 2016
Last verified: October 2016
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 Hospitals Cleveland Medical Center:

Primary Outcome Measures:
  • Young Mania Rating Scale (YMRS) [ Time Frame: Change from Baseline to End of Study ]

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


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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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 Hospitals Cleveland Medical Center
Eli Lilly and Company
Principal Investigator: Joseph R Calabrese, MD Case Western Reserve University / University Hospitals of Cleveland
  More Information

Responsible Party: Joseph Calabrese, MD, Director, Mood Disorders Program, University Hospitals Cleveland Medical Center Identifier: NCT00194064     History of Changes
Other Study ID Numbers: F1DMC-X136
Study First Received: September 13, 2005
Last Updated: October 3, 2016

Additional relevant MeSH terms:
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents processed this record on May 23, 2017