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

This study has been terminated.

First Received: September 13, 2005 Last Updated: December 5, 2007 History of Changes

Sponsor:	University Hospitals of Cleveland
Collaborator:	Eli Lilly and Company
Information provided by:	University Hospitals of Cleveland
ClinicalTrials.gov Identifier:	NCT00194064

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 III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment
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:

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Olanzapine

U.S. FDA Resources

Further study details as provided by University Hospitals of Cleveland:

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

Eligibility

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

Criteria

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

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 Hospitals of Cleveland

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

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Disease
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Bipolar Disorder
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Olanzapine
Antiemetics
Central Nervous System Depressants

Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Affective Disorders, Psychotic
Serotonin Agents
Pathologic Processes
Autonomic Agents
Mental Disorders
Therapeutic Uses
Mood Disorders
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010