Clinical trial NCT00266630: Efficacy and Safety of Olanzapine in the Extended Treatment for Manic or Mixed Episode of Bipolar I Disorder
Official title: Efficacy and Safety of Olanzapine in the Extended Treatment for Manic or Mixed Episode of Bipolar I Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Manic or Mixed Episode Associated With Bipolar I Disorder
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2005-12-19
Enrollment: 139
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Change From Baseline to Endpoint in Young Mania Rating Scale (YMRS) Total Scores - Olanzapine Monotherapy Arm Only
timeFrame: baseline through 18 weeks
measure: Number of Participants With Response of Manic Symptoms - Olanzapine Monotherapy Arm Only
timeFrame: baseline through 18 weeks
measure: Number of Participants With Remission of Mania - Olanzapine Monotherapy Arm Only
timeFrame: baseline through 18 weeks
measure: Number of Participants With Relapse of Manic Symptoms - Olanzapine Monotherapy Arm Only
timeFrame: baseline through 18 weeks
Secondary outcomes:
measure: Change From Baseline to Endpoint on the YMRS Total Score - Olanzapine + Mood Stabilizer Only
timeFrame: baseline through 18 weeks
measure: Clinical Global Impressions - Bipolar Version, Severity of Illness (CGI-BP) Overall, Visit Data
timeFrame: baseline, Weeks 1, 2, 4, 6, 10, 14, 18
measure: Number of Participants Who Experienced Switch to Symptomatic Depression as Measured by the Hamilton Depression Scale - 17 Item Version (HAMD-17)
timeFrame: baseline through 18 weeks
measure: Number of Participants With Relapse of Depressive Symptoms
timeFrame: baseline through 18 weeks
measure: Number of Participants Who Experienced Remission of Bipolar Disorder
timeFrame: Week 18
measure: Positive and Negative Syndrome Scale Positive Scores - Visit Data
timeFrame: baseline, Weeks 1, 2, 4, 6, 10, 14, 18
measure: Number of Participants Who Switched to Syndromic Depression
timeFrame: baseline through 18 weeks
measure: Maximum Change From Baseline to Endpoint on the Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS) - Total Score
timeFrame: baseline through 18 weeks
measure: Number of Participants With Treatment-Emergent Parkinsonism Based on DIEPSS Scores
timeFrame: baseline through 18 weeks
measure: Number of Participants With Treatment-Emergent Akathisia Based on DIEPSS Scores
timeFrame: baseline through 18 weeks
measure: Number of Participants With Treatment-Emergent Dystonia Based on DIEPSS Scores
timeFrame: baseline through 18 weeks
measure: Number of Participants With Treatment-Emergent Dyskenisia Based on DIEPSS Scores
timeFrame: baseline through 18 weeks
measure: Number of Participants With Potentially Clinically Significant Changes in Laboratory Analytes
timeFrame: baseline through 18 weeks
measure: Number of Participants With Potentially Clinically Significant Changes in Vital Signs and Weight
timeFrame: baseline through 18 weeks
measure: Number of Participants With Potentially Clinically Significant Changes in Electrocardiograms - High Fridericia Corrected QT Interval (QTcF)
timeFrame: baseline through 18 weeks
measure: Number of Participants With Treatment-emergent Abnormal, High, or Low Laboratory Values
timeFrame: baseline through 18 weeks
Other outcomes:
Locations:
city: Akita
country: Japan
facility: 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.
city: Chiba
country: Japan
facility: 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.
city: Fukuoka
country: Japan
facility: 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.
city: Gunma
country: Japan
facility: 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.
city: Hokkaido
country: Japan
facility: 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.
city: Hyogo
country: Japan
facility: 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.
city: Nara
country: Japan
facility: 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.
city: Okayama
country: Japan
facility: 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.
city: Okinawa
country: Japan
facility: 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.
city: Saitama
country: Japan
facility: 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.
city: Tokyo
country: Japan
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: