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

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

Study Type: Interventional

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

Study Primary Completion Date: May 2009

Intervention(s) in this Clinical Trial

• Drug: olanzapine
  • 5-20 mg, oral, daily, 18 weeks.
• Drug: olanzapine
  • initial dose: 10mg, oral, daily for 1 week. Subsequent dosing: 5-20 mg, oral, daily for 17 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • olanzapine extension for BMAC patients who completed Visit 8
• Experimental: B
  • olanzapine extension for BMAC patients who discontinued at Visit 4 or 5

Primary 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
    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
    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
    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
    Safety Issue?: No

Secondary 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
    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
    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
    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
    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
    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
    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
    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
    Safety Issue?: Yes
• Assess the incidence and severity of extrapyramidal symptoms as measured by Drug Induced Extra-Pyramidal Symptoms Scale.
  • Time Frame: 18 weeks
    Safety Issue?: Yes
• Assess the changes in vital signs and weight, laboratory analyses and ECGs.
  • Time Frame: 18 weeks
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Eli Lilly and Company

Overall Clinical Trial Officials and Contacts

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 Eli Lilly and Company  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00266630

Study ID Number: 9637

ClinicalTrials.gov Identifier: NCT00266630

Health Authority: Japan: Ministry of Health, Labor and Welfare

Lilly Clinical Trial Registry