Efficacy and Safety of Olanzapine in the Extended Treatment for Manic or Mixed Episode of Bipolar I Disorder

Condition(s) targeted: Manic or Mixed Episode Associated With Bipolar I Disorder

Intervention: olanzapine (Drug); olanzapine (Drug)

Phase: Phase 3

Status: Recruiting

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

Overall contact:
There may be multiple sites in this clinical trial. 1-877-CTLILLY(1-877-285-4559) or, Phone: 1-317-615-4559

The efficacy and safety of the extended treatment to patients with most recent episode manic or mixed who complete previous double blind study will be examined

Official title: Efficacy and Safety of Olanzapine in the Extended Treatment for Manic or Mixed Episode of Bipolar I Disorder

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome:

Assess the efficacy of olanzapine in patients by change from baseline to endpoint in Young Mania Rating Scale (YMRS) total scores.

Assess the efficacy of olanzapine in terms of response as defined by a 50% or more reduction in YMRS total score from baseline from feeder study to any visit

Assess the efficacy of olanzapine in terms of remission of mania as defined as a YMRS total score of less than or equal to 12 at any visit.

Assess the efficacy of olanzapine in terms of relapse of manic symptoms as defined by remission in Study BMAC and patient obtains YMRS total score of greater than or equal to 15 at any time during BMEX.

Secondary outcome:

Assess manic symptoms in both treatment groups as measured by change from baseline to endpoint on the YMRS total score.

Assess manic symptoms in both treatment groups as measured by change from baseline to endpoint on the Clinical Global Impressions - Bipolar Version, Severity of Illness (CGI-BP) total score.

Assess Depressive symptoms in both treatment groups by incidence of depressive symptoms as measured by the Hamilton Depression Scale - 17 item version (HAMD-17).

Assess Depressive Symptoms in both treatment groups by incidence of relapse of depressive symptoms for patients meeting remission criteria for bipolar disorder in the BMAX and has a HAMD-17 total score greater than or equal to 13 at any time.

To assess overall Bipolar symptomology as measured by remission of bipolar disorder and change from baseline to endpoint on CGI-BP overall score.

Assess psychotic symptoms as measured by change from baseline to endpoint in Positive and Negative Syndrome Scale positive scores.

Assess incidence of Switch-to-Depression as defined as a shift from a Manic Episode at baseline to a Major Depressive Episode, at any point after randomization, based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision.

Assess the incidence and severity of treatment-emergent adverse events as measured by untoward medical occurences, laboratory analytes, vitals signs, and ECG.

Assess the incidence and severity of extrapyramidal symptoms as measured by Drug Induced Extra-Pyramidal Symptoms Scale.

Assess the changes in vital signs and weight, laboratory analyses and ECGs.

Minimum age: 20 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Enrolled in and completed Study BMAC, or those who discontinued Study BMAC at Visit 4

or Visit 5 due to lack of efficacy and for whom the 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 BMAC is 4 days or more later than the scheduled

date of first visit in BMEX

There may be multiple sites in this clinical trial. 1-877-CTLILLY(1-877-285-4559) or, Phone: 1-317-615-4559

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 807-8555, Japan; Recruiting
Eli Lilly

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; Recruiting
Eli Lilly

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., Saga 842-0192, Japan; Recruiting
Eli Lilly

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; Recruiting
Eli Lilly

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., Nagano 384-8540, Japan; Recruiting
Eli Lilly

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., Kumamoto 861-0002, Japan; Recruiting
Eli Lilly

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; Recruiting
Eli Lilly

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 700-8558, Japan; Recruiting
Eli Lilly

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 160-0023, Japan; Recruiting
Eli Lilly

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 283-0062, Japan; Recruiting
Eli Lilly

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 370-2455, Japan; Recruiting
Eli Lilly

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., Aichi 470-1168, Japan; Recruiting
Eli Lilly

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., Osaka 561-0803, Japan; Recruiting
Eli Lilly

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 904-2222, Japan; Recruiting
Eli Lilly

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 097-8555, Japan; Recruiting
Eli Lilly

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 015-8511, Japan; Recruiting
Eli Lilly

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., Kanagawa 220-0004, Japan; Recruiting
Eli Lilly

Lilly Clinical Trial Registry

Starting date: November 2005
Ending date: June 2009
Last updated: September 25, 2008