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Trial record 13 of 69 for:    "Bipolar Disorder" | "Olanzapine"

Trial of Olanzapine in Patients With Manic or Mixed Episode of Bipolar I Disorder

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ClinicalTrials.gov Identifier: NCT00129220
Recruitment Status : Completed
First Posted : August 11, 2005
Results First Posted : February 15, 2010
Last Update Posted : December 28, 2010
Sponsor:
Information provided by:
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE August 8, 2005
First Posted Date  ICMJE August 11, 2005
Results First Submitted Date  ICMJE January 21, 2010
Results First Posted Date  ICMJE February 15, 2010
Last Update Posted Date December 28, 2010
Study Start Date  ICMJE July 2005
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2010)
Change From Baseline to 3 Week Endpoint in Young Mania Rating Scale (YMRS) Total Score [ Time Frame: Baseline, 3 weeks ]
The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.
Original Primary Outcome Measures  ICMJE
 (submitted: August 8, 2005)
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.
Change History Complete list of historical versions of study NCT00129220 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2010)
  • Change From Baseline to 6 Week Endpoint in Young Mania Rating Scale (YMRS) [ Time Frame: Baseline, 6 weeks ]
    The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.
  • Remission Rate of Bipolar Disorder (Olanzapine Versus Haloperidol) [ Time Frame: 6 weeks ]
    Remission of bipolar disorder was defined as completing the 6-week period with meeting the criteria for Young Mania Rating Scale (YMRS) total score of 12 or less and 17-Item Hamilton Depression Rating Scale (HAMD-17) total scores of 7 or less at Week 6. YMRS is an 11-item scale measuring severity of manic episodes; total score ranges = 0 (normal) to 60 (severe). The 17-item HAMD measures depression severity; total score ranges = 0 (normal) to 52 (severe). Remission Rate (percent) = number of patients meeting remission criteria divided by number of patients in treatment arm, multiplied by 100.
  • Change From Baseline to 6 Week Endpoint in Clinical Global Impressions - Bipolar Version (CGI-BP), Overall Severity of Illness [ Time Frame: Baseline, 6 weeks ]
    A global rating scale for severity of patients adapted to bipolar disorder. Measures severity of the patient's overall severity of overall mood symptoms on a scale of 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
  • Change From Baseline to 3 Week and 6 Week Endpoints in Clinical Global Impression - Bipolar Version (CGI-BP) Mania Subscale [ Time Frame: Baseline, 3 weeks, 6 weeks ]
    A global rating scale for severity of patients adapted to bipolar disorder. Measures severity of the patient's overall severity of manic symptoms on a scale of 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
  • Response Rate of Manic Symptoms at 3 Weeks and 6 Weeks [ Time Frame: Baseline, 3 weeks, 6 weeks ]
    Participants who had 50 percent or more decrease from the baseline in YMRS total scores were defined as a responder. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. Response Rate (percent) = number of patients meeting response criterion for manic symptom divided by number of patients in treatment arm, multiplied by 100.
  • Remission Rate of Manic Symptoms at 3 Weeks and 6 Weeks [ Time Frame: 3 weeks, 6 weeks ]
    Participants who had a YMRS total score of 12 or less were considered to be in remission of manic symptoms. YMRS is an 11-item scale that measures severity of manic episodes; total score ranges from 0 (normal) to 60 (severe). Remission Rate (percent) = number of patients meeting remission criteria divided by number of patients in treatment arm, multiplied by 100.
  • Percentage of Participants Who Switched to Symptomatic Depression [ Time Frame: 3 weeks, 6 weeks ]
    Switch to symptomatic depression was defined as HAMD-17 total score ≥13 at any time in the participants with HAMD-17 total scores ≤7 at baseline. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
  • Change From Baseline to 3 Week and 6 Week Endpoints in the Positive Subscore of Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Baseline, 3 weeks, 6 weeks ]
    Assesses positive symptoms associated with schizophrenia. 7 items make up the Positive scale (ex. delusions, conceptual disorganization, and hallucinatory behavior). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total Positive Subscale scores range from 7 to 49. For this study, the score was converted to 0 to 6 for each item range; hence, the total positive subscale score ranges from 0 to 42.
  • Percentage of Participants Who Switched to Syndromic Depression [ Time Frame: 3 weeks, 6 weeks ]
    Switch to syndromic depression was operationally defined by meeting both of the following criteria: At baseline, the symptoms did not meet the criteria for a mixed episode based on the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR). The critiera were met for a Major Depressive Episode (MDE), at any point after randomization, based on DSM-IV-TR. Rather than the 2-week period required for an MDE in the DSM-IV-TR, the patient had to meet the criteria of an MDE for at least 7 consecutive days (during Weeks 1 through 6).
  • Maximum Change From Baseline During 6-Week Period in Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Total Score [ Time Frame: Baseline to 6 weeks ]
    Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS) is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the sum of the 8 item scores, for a total range of 0 (normal) to 32 (severe).
Original Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2005)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Olanzapine in Patients With Manic or Mixed Episode of Bipolar I Disorder
Official Title  ICMJE Placebo- and Haloperidol-Controlled Double-Blind Trial of Olanzapine in Patients With Manic or Mixed Episode of Bipolar I Disorder
Brief Summary The purpose of this study is to confirm the efficacy of olanzapine in the treatment of manic or mixed symptoms associated with bipolar I disorder.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Bipolar Disorder
Intervention  ICMJE
  • Drug: olanzapine
    5-20 mg, oral, once daily (evening), for 6 weeks
    Other Names:
    • LY170053
    • Zyprexa
  • Drug: haloperidol
    2.5-10 mg, oral, twice daily (morning and evening), for 6 weeks.
  • Drug: placebo
    placebo, oral tablets, twice daily (morning and evening), for 3 weeks
Study Arms  ICMJE
  • Experimental: Olanzapine
    olanzapine: 5 to 20 mg per day for 6 weeks
    Intervention: Drug: olanzapine
  • Active Comparator: Haloperidol
    haloperidol: 2.5 to 10 mg per day for 6 weeks
    Intervention: Drug: haloperidol
  • Placebo Comparator: Placebo
    placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
    Intervention: Drug: placebo
Publications * Katagiri H, Takita Y, Tohen M, Higuchi T, Kanba S, Takahashi M. Efficacy and safety of olanzapine in the treatment of Japanese patients with bipolar I disorder in a current manic or mixed episode: a randomized, double-blind, placebo- and haloperidol-controlled study. J Affect Disord. 2012 Feb;136(3):476-84. doi: 10.1016/j.jad.2011.10.045. Epub 2011 Nov 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 25, 2009)
224
Original Enrollment  ICMJE
 (submitted: August 8, 2005)
280
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Meet the criteria for manic or mixed episodes according to the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (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".
  • Have a total score on the Young Mania Rating Scale (YMRS) of at least 20 at Visit 1 and Visit 2.

Exclusion Criteria:

  • Have received an antidepressant or a psychostimulant within 5 days prior to Visit 1.
  • The duration of the current episode is more than 90 days at Visit 1.
  • Have a history or a diagnosis of diabetes mellitus.
  • Have received any psychotropic medication within 2 days prior to Visit 2 (except for benzodiazepines).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00129220
Other Study ID Numbers  ICMJE 9636
F1D-JE-BMAC ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chief Medical Officer, Eli Lilly
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Monday-Friday 9am-5pm Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP