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

Primary Purpose

Bipolar Disorder

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Olanzapine
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospitals of Cleveland

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Olanzapine

Arm Description

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

Outcomes

Primary Outcome Measures

Young Mania Rating Scale (YMRS)

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
October 3, 2016
Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00194064
Brief Title
Pilot Study Evaluating the Safety and Efficacy of Open-Label Olanzapine
Official Title
Pilot Study Evaluating the Safety and Efficacy of Open-Label Olanzapine Monotherapy in Treatment Refractory Bipolar Disorder Mania
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment
Study Start Date
July 2002 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Olanzapine
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Olanzapine
Other Intervention Name(s)
Zyprexa
Primary Outcome Measure Information:
Title
Young Mania Rating Scale (YMRS)
Time Frame
Change from Baseline to End of Study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph R Calabrese, MD
Organizational Affiliation
Case Western Reserve University / University Hospitals of Cleveland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44140
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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