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Double-Blind Trial of Olanzapine in Patients with Manic or Mixed Episode of Bipolar I Disorder - Article


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Insulin - Mixed

Humalog Mix 75/25; Humulin 50/50; Humulin 70/30; Iletin II Mixed; Novolin 70/30; NovoLog Mix

Clinical Trial: Double-Blind Trial of Olanzapine in Patients with Manic or Mixed Episode of Bipolar I Disorder

This study is currently recruiting patients.
Verified by Eli Lilly and Company August 2005

Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00129220

Purpose

To confirm the efficacy of olanzapine in the treatment of manic or mixed symptoms associated with bipolar Ⅰ disorder.
Condition Intervention Phase
Manic or mixed episode associated with bipolar I disorder
  Drug: olanzapine
 Phase III

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: Placebo- and Haloperidol-Controlled Double-Blind Trial of Olanzapine in Patients with Manic or Mixed Episode of Bipolar I Disorder

Further Study Details: 
Primary Outcomes: To confirm the superiority of olanzapine (5 to 20 mg/day) versus placebo in improving the severity of the manic symptoms, as measured by the Young Mania Rating Scale, associated with bipolar I disorder.
Secondary Outcomes: To confirm the efficacy and safety of Olanzapine at the following points of views by doble-blind trial.; a) Overall bipolar symptomatology; b) Manic symptoms; c) Depression symptoms; d) Psychotic symptoms; e) Switch-to-depression; f) Severity of Extrapyramidal symptoms; g) AE, Vitals signs, laboratory test, ECG
Expected Total Enrollment:  280

Study start: July 2005

Eligibility

Ages Eligible for Study:  20 Years   -   65 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  1. Meet the criteria of manic or mixed episodes according to the DSM-IV-TR and have a diagnosis of “294.4x Bipolar I Disorder, Most Recent Episode Manic” or “296.6x Bipolar I Disorder, Most Recent Episode Mixed”.
  2. Have a score on the YMRS total score of at least 20 at Visit 1 and Visit 2.

Exclusion Criteria:

  1. Have received an antidepressant or a psychostimulant within 5 days prior to Visit 1.
  2. The duration of the current episode is more than 90 days at Visit 1.
  3. Have a history or a diagnosis of diabetes mellitus.
  4. Have received any psychotropic medication within 2 days prior to Visit 2 (except for benzodiazepines.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00129220

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

Japan
      For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Monday-Friday, 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician, Hokkaido,  Japan; Recruiting
Eli Lilly

      For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Monday-Friday, 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician, Akita,  Japan; Recruiting
Eli Lilly

      For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Monday-Friday, 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician, Gunma,  Japan; Recruiting
Eli Lilly

      For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Monday-Friday, 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician, Chiba,  Japan; Recruiting
Eli Lilly

      For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Monday-Friday, 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician, Tokyo,  Japan; Recruiting
Eli Lilly

      For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Monday-Friday, 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician, Kanagawa,  Japan; Recruiting
Eli Lilly

      For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Monday-Friday, 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician, Nagano,  Japan; Recruiting
Eli Lilly

      For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Monday-Friday, 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician, Aichi,  Japan; Recruiting
Eli Lilly

      For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Monday-Friday, 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician, Nara,  Japan; Recruiting
Eli Lilly

      For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Monday-Friday, 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician, Osaka,  Japan; Recruiting
Eli Lilly

      For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Monday-Friday, 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician, Hyogo,  Japan; Recruiting
Eli Lilly

      For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Monday-Friday, 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician, Okayama,  Japan; Recruiting
Eli Lilly

      For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Monday-Friday, 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician, Yamaguchi,  Japan; Recruiting
Eli Lilly

      For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Monday-Friday, 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician, Fukuoka,  Japan; Recruiting
Eli Lilly

      For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Monday-Friday, 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician, Saga,  Japan; Recruiting
Eli Lilly

      For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Monday-Friday, 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician, Kumamoto,  Japan; Recruiting
Eli Lilly

      For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Monday-Friday, 9:00 AM to 5:00 PM Eastern Time (UTC/GMT -5 hours, EST) or speak with your personal physician, Okinawa,  Japan; Recruiting
Eli Lilly

Study chairs or principal investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Monday-Friday 9am-5pm Eastern time (UTC/GMT - 5 hours, EST),  Study Director,  Eli Lilly and Company   

More Information

Study ID Numbers:  9636
Last Updated:  August 10, 2005
Record first received:  August 8, 2005
ClinicalTrials.gov Identifier:  NCT00129220
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-08-23


Source: ClinicalTrials.gov
Cache Date: August 24, 2005


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Page Updated: June 1, 2005
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