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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 Only

Number 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 Only

Clinical 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

Page last updated: August 23, 2015

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