Efficacy and Safety of Olanzapine in the Extended Treatment for Manic or Mixed Episode of Bipolar I Disorder
Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Manic or Mixed Episode Associated With Bipolar I Disorder
Intervention: olanzapine (Drug); lithium (Drug); valproate (Drug); carbamazepine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Eli Lilly and Company Official(s) and/or principal investigator(s): Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT-5 hours, EST), Study Director, Affiliation: Eli Lilly and Company
Summary
The efficacy and safety of the extended treatment to patients with most recent episode manic
or mixed who completed previous double blind study (F1D-JE-BMAC [Study BMAC]) will be
examined.
Clinical Details
Official title: Efficacy and Safety of Olanzapine in the Extended Treatment for Manic or Mixed Episode of Bipolar I Disorder
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change From Baseline to Endpoint in Young Mania Rating Scale (YMRS) Total Scores - Olanzapine Monotherapy Arm OnlyNumber of Participants With Response of Manic Symptoms - Olanzapine Monotherapy Arm Only Number of Participants With Remission of Mania - Olanzapine Monotherapy Arm Only Number of Participants With Relapse of Manic Symptoms - Olanzapine Monotherapy Arm Only
Secondary outcome: Change From Baseline to Endpoint on the YMRS Total Score - Olanzapine + Mood Stabilizer OnlyClinical Global Impressions - Bipolar Version, Severity of Illness (CGI-BP) Overall, Visit Data Number of Participants Who Experienced Switch to Symptomatic Depression as Measured by the Hamilton Depression Scale - 17 Item Version (HAMD-17) Number of Participants With Relapse of Depressive Symptoms Number of Participants Who Experienced Remission of Bipolar Disorder Positive and Negative Syndrome Scale Positive Scores - Visit Data Number of Participants Who Switched to Syndromic Depression Maximum Change From Baseline to Endpoint on the Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS) - Total Score Number of Participants With Treatment-Emergent Parkinsonism Based on DIEPSS Scores Number of Participants With Treatment-Emergent Akathisia Based on DIEPSS Scores Number of Participants With Treatment-Emergent Dystonia Based on DIEPSS Scores Number of Participants With Treatment-Emergent Dyskenisia Based on DIEPSS Scores Number of Participants With Potentially Clinically Significant Changes in Laboratory Analytes Number of Participants With Potentially Clinically Significant Changes in Vital Signs and Weight Number of Participants With Potentially Clinically Significant Changes in Electrocardiograms - High Fridericia Corrected QT Interval (QTcF) Number of Participants With Treatment-emergent Abnormal, High, or Low Laboratory Values
Eligibility
Minimum age: 20 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Enrolled in and completed Study BMAC (NCT00129220), or those who discontinued Study
BMAC at Visit 4 or Visit 5 due to lack of efficacy and for whom the Young Mania
Rating Scale (YMRS) total score at the time of discontinuation was not lower than
that at baseline of Study BMAC
- Are diagnosed as "294. 4x Bipolar I Disorder, Most Recent Episode Manic" or "296. 6x
Bipolar I Disorder, Most Recent Episode Mixed," as determined by the
Mini-International Neuropsychiatric Interview (MINI)
Exclusion Criteria:
- Have a diagnosis of diabetes mellitus
- Significant protocol deviation in Study BMAC
- The actual date of the final visit of Study BMAC is 4 days or more later than the
scheduled date of first visit in Study BMEX
Locations and Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Akita 010-1654, Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Chiba 292-0061, Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Fukuoka 812-8582, Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Gunma 371-8511, Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Hokkaido 005-0004, Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Hyogo 663-8501, Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Nara 634-8522, Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Okayama 710-0055, Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Okinawa 900-0005, Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Saitama 343-0032, Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Tokyo 151-0053, Japan
Additional Information
Starting date: November 2005
Last updated: December 10, 2010
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