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

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00194064
• Other study ID #: F1DMC-X136
• Status: Terminated
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: October 3, 2016
• Start date: July 2002
• Est. completion date: February 2006

Study information

• Verified date: October 2016
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• Olanzapine

Locations

Country	Name	City	State
United States	University Hospitals of Cleveland	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Young Mania Rating Scale (YMRS)		Change from Baseline to End of Study	No