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Trial record 18 of 69 for:    "Bipolar Disorder" | "Olanzapine"

A Study in the Treatment of Acute Mania

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00767715
Recruitment Status : Terminated (Trial discontinued due to low enrollment)
First Posted : October 7, 2008
Last Update Posted : October 7, 2008
Sponsor:
Information provided by:
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE October 3, 2008
First Posted Date  ICMJE October 7, 2008
Last Update Posted Date October 7, 2008
Study Start Date  ICMJE October 2004
Actual Primary Completion Date April 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2008)
Time to remission by Young Mania Rating Scale, MADRS-S and CGI-BP [ Time Frame: 5 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2008)
  • Resource utilization Clinical Report Form (RUCRF) [ Time Frame: 5 months ]
  • Disability free day assessment (DFDA) [ Time Frame: 5 months ]
  • Medication compliance [ Time Frame: 5 months ]
  • Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) [ Time Frame: 5 months ]
  • Euro Qol instrument [ Time Frame: 5 months ]
  • Drug Attitude Inventory (DAI) [ Time Frame: 5 months ]
  • Response by Y-MRS [ Time Frame: 5 months ]
  • Frequency of and time to relapse into mania by Y-MRS and CGI-BP [ Time Frame: 5 months ]
  • Frequency of and time to switch to depression by MADRS-S and DSRS [ Time Frame: 5 months ]
  • Time to remission in patients with psychotic features by SCID-I judgement, Y-MRS item 8 and PANSS positive items mean sum [ Time Frame: 5 months ]
  • Adverse events [ Time Frame: 5 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study in the Treatment of Acute Mania
Official Title  ICMJE A Randomized Open Label Study on the Efficacy, Tolerability, and Total Costs of Olanzapine Versus Conventional Antipsychotics in the Treatment of Acute Mania in Sweden
Brief Summary The purpose of this study is to test the efficacy and total costs of olanzapine versus commonly used conventional antipsychotics in Sweden.
Detailed Description

The primary objective is to show that the efficacy of olanzapine is non-inferior to the conventional antipsychotics haloperidol or zuclopentixol in the treatment of an acute manic or mixed episode of bipolar disorder. Efficacy is defined as time to remission, as measured by the total scores of the Young Mania Rating Scale (Y-MRS), MADRS-S, and Clinical Global Impression - Bipolar (CGI-BP). Time from baseline to remission is defined as the primary efficacy measure. Remission is defined as a Y-MRS score <=12 AND a MADRS-S score <=12 AND CGI-BP = 1 or 2.

Secondary efficacy assessments will include time from baseline to

  • Response, as defined as a reduction of Y-MRS score greater than or equal to 50% compared to baseline
  • Relapse of mania, as defined as a Y-MRS score >= 16 AND CGI-BP >2 after having met the criteria for remission
  • Switch into depression, as defined as a MADRS-S score >=17 AND fulfilled criteria for Major Depression as self-assessed by DSRS.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bipolar Disorder
Intervention  ICMJE
  • Drug: olanzapine
    physician determined dose, oral, daily, 5 months
    Other Names:
    • LY170053
    • Zyprexa
  • Drug: haloperidol
    physician determined dose, oral, parenteral (<= 3 days), daily, 5 months
  • Drug: zuclopentixol
    physician determined dose, oral, parenteral (<= 3 days), daily, 5 months
Study Arms  ICMJE
  • Experimental: A
    Patients will be given olanzapine
    Intervention: Drug: olanzapine
  • Active Comparator: B
    Patients will be given either haloperidol or zuclopentixol
    Interventions:
    • Drug: haloperidol
    • Drug: zuclopentixol
Publications * Not Provided

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: October 3, 2008)
11
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2005
Actual Primary Completion Date April 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of bipolar I disorder and currently display an acute manic or mixed episode (with or without psychotic features)
  • Patients must have a Y-MRS total score of greater or equal to 20 at visit 2
  • Patients must have experienced at least one manic or mixed episode prior to study enrollment
  • Female of childbearing potential must be using a medically accepted means of contraception, or practice sexual abstinence
  • Each patient must have a level of understanding sufficient to communicate intelligently with study personnel
  • Patients must be considered reliable
  • Each patient must understand the nature of the study and signed informed consent

Exclusion Criteria:

  • Female patients who are pregnant or lactating
  • Serious, unstable illnesses such that hospitalization for the disease is anticipated within 3 month or death is anticipated within 3 years
  • Uncorrected hypothyroidism or hyperthyroidism
  • Narrow-angle glaucoma
  • History of allergic reactions or intolerance to study medications
  • DSM-IV substance dependence within the past 30 days at the judgement of the investigator
  • Judged clinically to be at serious suicidal risk
  • Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections prior to visit 2
  • Any patient treated with clozapine within 4 weeks prior to visit 2
  • Subjects who have received treatment with ECT within one month prior to visit 1
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00767715
Other Study ID Numbers  ICMJE 7313
F1D-SO-HGLY
Has Data Monitoring Committee No
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 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date October 2008

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