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

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00266630

Purpose

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

Condition	Intervention	Phase
Manic or Mixed Episode Associated With Bipolar I Disorder	Drug: olanzapine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of Olanzapine in the Extended Treatment for Manic or Mixed Episode of Bipolar I Disorder

Resource links provided by NLM:

Drug Information available for: Olanzapine

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Assess the efficacy of olanzapine in patients by change from baseline to endpoint in Young Mania Rating Scale (YMRS) total scores. [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
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. [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
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. [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess manic symptoms in both treatment groups as measured by change from baseline to endpoint on the YMRS total score. [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
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. [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
Assess Depressive symptoms in both treatment groups by incidence of depressive symptoms as measured by the Hamilton Depression Scale - 17 item version (HAMD-17). [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
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. [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
To assess overall Bipolar symptomology as measured by remission of bipolar disorder and change from baseline to endpoint on CGI-BP overall score. [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
Assess psychotic symptoms as measured by change from baseline to endpoint in Positive and Negative Syndrome Scale positive scores. [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
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. [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
Assess the incidence and severity of treatment-emergent adverse events as measured by untoward medical occurences, laboratory analytes, vitals signs, and ECG. [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ]
Assess the incidence and severity of extrapyramidal symptoms as measured by Drug Induced Extra-Pyramidal Symptoms Scale. [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ]
Assess the changes in vital signs and weight, laboratory analyses and ECGs. [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	139
Study Start Date:	November 2005
Study Completion Date:	May 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental olanzapine extension for BMAC patients who completed Visit 8	Drug: olanzapine 5-20 mg, oral, daily, 18 weeks.
B: Experimental olanzapine extension for BMAC patients who discontinued at Visit 4 or 5	Drug: olanzapine initial dose: 10mg, oral, daily for 1 week. Subsequent dosing: 5-20 mg, oral, daily for 17 weeks.

Eligibility

Ages Eligible for Study:	20 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00266630

Locations

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.
Akita, Japan, 010-1654
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, Japan, 634-8522
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, Japan, 812-8582
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, Japan, 292-0061
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, Japan, 343-0032
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, Japan, 151-0053
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, Japan, 371-8511
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, Japan, 900-0005
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, Japan, 663-8501
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, Japan, 005-0004
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, Japan, 710-0055

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

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)

Eli Lilly and Company

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	9637, F1D-JE-BMEX
Study First Received:	December 15, 2005
Last Updated:	June 4, 2009
ClinicalTrials.gov Identifier:	NCT00266630 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Disease
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Olanzapine
Psychotropic Drugs
Antiemetics

Central Nervous System Depressants
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010