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

NCT00194064 | Terminated Phase 3 DMC

• 1 other identifier: F1DMC-X136
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• Young Mania Rating Scale (YMRS)

  Change from Baseline to End of Study

Study Arms (1)

Olanzapine

EXPERIMENTAL

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

Interventions

Olanzapine DRUG

Also known as: Zyprexa

Olanzapine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

University Hospitals of Cleveland

Cleveland, Ohio, 44140, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Joseph R Calabrese, MD

  Case Western Reserve University / University Hospitals of Cleveland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Mood Disorders Program

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 19, 2005
• Study Start: July 1, 2002
• Primary Completion: February 1, 2006
• Study Completion: February 1, 2006
• Last Updated: October 4, 2016

Record last verified: 2016-10

Locations

US (1)