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Trial record 1 of 1 for:    NCT00253162
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A Study of the Effectiveness and Safety of Risperidone Compared With Placebo in the Treatment of Manic Episodes Associated With Bipolar I Disorder, and the Maintenance of Anti-manic Effectiveness of Risperidone Compared With Haloperidol

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ClinicalTrials.gov Identifier: NCT00253162
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : January 28, 2011
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Tracking Information
First Submitted Date  ICMJE November 10, 2005
First Posted Date  ICMJE November 15, 2005
Last Update Posted Date January 28, 2011
Study Start Date  ICMJE March 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 10, 2005)
Acute efficacy: Change in Young Mania Rating Scale (YMRS) total score from baseline to endpoint of 3 weeks of acute treatment period.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00253162 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2011)
Maintenance efficacy: Young Mania Rating Scale, Clinical Global Impression-Severity of Illness scale, Global Assessment Scale, Brief Psychiatric Rating Scale, Montgomery Asberg Depression Rating Scale; incidence of adverse events throughout the study
Original Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2005)
  • Maintenance efficacy: Young Mania Rating Scale, Clinical Global Impression-Severity of Illness scale, Global Assessment Scale, Brief Psychiatric Rating Scale, and Montgomery Asberg Depression Rating Scale
  • incidence of adverse events throughout the study
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Effectiveness and Safety of Risperidone Compared With Placebo in the Treatment of Manic Episodes Associated With Bipolar I Disorder, and the Maintenance of Anti-manic Effectiveness of Risperidone Compared With Haloperidol
Official Title  ICMJE The Efficacy And Safety Of Flexible Dose Ranges Of Risperidone Versus Placebo Or Haloperidol In The Treatment Of Manic Episodes Associated With Bipolar I Disorder.
Brief Summary The purpose of the study is to assess the effectiveness and safety of risperidone (an antipsychotic medication) compared with placebo after 3 weeks of treatment in patients with bipolar disorder who are experiencing manic episodes. A secondary purpose of the study is to assess the maintenance of risperidone effectiveness versus haloperidol (an antipsychotic medication) after 12 weeks of treatment.
Detailed Description

Antipsychotic agents have, for a long time, been used to alleviate the severe behavioral problems associated with manic episodes. Risperidone, widely used in the treatment of schizophrenia, has been shown to be effective in the treatment of manic and mixed episodes associated with bipolar disorders. This is a randomized, double-blind study to evaluate the effectiveness and safety of risperidone compared with placebo after 3 weeks of treatment in patients with bipolar disorder who are experiencing manic episodes. A secondary objective is to estimate the difference between the anti-manic efficacy of risperidone and haloperidol (active comparator) after 12 weeks of treatment. Haloperidol also serves as an internal control for the 3-week treatment period. The study has two 2 phases: an acute period consisting of 3 weeks of double-blind treatment (risperidone, haloperidol, or placebo) followed by a maintenance period consisting of 9 weeks of double-blind treatment (risperidone or haloperidol) or 9 weeks of open-label treatment (risperidone). Patients receive study medication to be taken orally once a day at gradually increasing doses during the first week (risperidone, a range of 1 - 6 mg/day or haloperidol, a range of 2 - 12 mg/day) to achieve optimal effectiveness, while minimizing any intolerance to the drug. Daily treatment continues at the optimal dose through Week 3 of the first phase. After completing the 3-week double-blind period, patients can continue double-blind treatment for an additional 9 weeks at the optimal dose (with placebo patients crossed over to risperidone), or enter the 9-week open-label period of risperidone treatment. Adjustment to achieve an optimal dosage is made for those patients whose medication is changed upon entering the second phase.

The primary measure of effectiveness (acute efficacy) is the change in Young Mania Rating Scale (YMRS) total score from baseline to the endpoint at 3 weeks of the acute treatment period. Additional efficacy measures for the study assess maintenance efficacy. These measures include the Clinical Global Impression-Severity of Illness (CGI-S) scale; Global Assessment Scale (GAS), which assesses the patient's level of functioning; Brief Psychiatric Rating Scale (BPRS), a scale for measuring psychotic symptoms; and the Montgomery Asberg Depression Rating Scale (MADRS), which evaluates symptoms of depression. Safety assessments include the incidence of adverse events and measurement of vital signs (temperature, pulse, blood pressure) throughout the study; evaluation of the presence and severity of extrapyramidal symptoms by the Extrapyramidal Symptom Rating Scale (ESRS) at specified intervals; and clinical laboratory tests (hematology, biochemistry, urinalysis) at the start and end of both phases of the study. The study hypothesis is that 3 weeks of daily treatment with risperidone is more effective than placebo, as measured by Young Mania Rating Scale scores, in the treatment of the manic phase of Bipolar I Disorder. Acute phase: Risperidone orally, once-daily: 2 mg on Day 1, 1 - 3 mg on Days 2 to 4, and 1 - 6 mg on Days 5 to 21; or haloperidol orally, once-daily: 4 mg on Days 1 to 4 and 2 - 12 mg on Days 5 to 21; or placebo orally, once-daily Days 1 to 21. Maintenance phase: optimal dose of risperidone or haloperidol for 9 weeks (placebo patients cross over to risperidone) or Open-label phase: risperidone for 9 weeks.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Bipolar Disorders
  • Manic Disorder
Intervention  ICMJE Drug: risperidone
Study Arms  ICMJE Not Provided
Publications * Smulevich AB, Khanna S, Eerdekens M, Karcher K, Kramer M, Grossman F. Acute and continuation risperidone monotherapy in bipolar mania: a 3-week placebo-controlled trial followed by a 9-week double-blind trial of risperidone and haloperidol. Eur Neuropsychopharmacol. 2005 Jan;15(1):75-84.

*   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: January 27, 2011)
439
Original Enrollment  ICMJE
 (submitted: November 10, 2005)
435
Actual Study Completion Date  ICMJE September 2002
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Meets diagnosis criteria for Bipolar I Disorder - Most Recent Episode Manic (Diagnostic and Statistical Manual of Mental Diseases, 4th edition, (DSM-IV))
  • meets DSM-IV criteria for a current manic episode
  • hospitalized voluntarily at study initiation
  • history of at least one documented manic or mixed episode prior to study initiation
  • total score of >=20 on the Young Mania Rating Scale (YMRS) and total score of <=20 on the Montgomery Asberg Depression Rating Scale (MADRS) at start of the study

Exclusion Criteria:

  • Meets DSM-IV criteria for Schizoaffective Disorder or for rapid cycling
  • borderline or antisocial personality disorder
  • history of substance dependence (excluding nicotine and caffeine) within the 3 months prior to study initiation
  • seizure disorder
  • females who are pregnant or nursing, or those lacking adequate contraception.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00253162
Other Study ID Numbers  ICMJE CR006049
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PRS Account Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Verification Date January 2011

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