A Study of the Effectiveness and Safety of Risperidone Versus Placebo as add-on Therapy to Mood Stabilizers, in the Treatment of Manic Episodes Associated With Bipolar Disorder.

This study has been completed.
Sponsor:
Information provided by:
Janssen Pharmaceutica N.V., Belgium
ClinicalTrials.gov Identifier:
NCT00250367
First received: November 4, 2005
Last updated: November 24, 2010
Last verified: November 2010

November 4, 2005
November 24, 2010
October 1997
Not Provided
Change in Young Mania Rating Scale (YMRS) total score from baseline to end of double-blind treatment
Same as current
Complete list of historical versions of study NCT00250367 on ClinicalTrials.gov Archive Site
Changes from baseline to end of double-blind treatment in Brief Psychiatric Rating Scale (BPRS), Clinical Global Impression (CGI) - severity, and Hamilton Depression Rating Scale (HAMD); incidence of adverse events throughout study.
Same as current
Not Provided
Not Provided
 
A Study of the Effectiveness and Safety of Risperidone Versus Placebo as add-on Therapy to Mood Stabilizers, in the Treatment of Manic Episodes Associated With Bipolar Disorder.
The Safety And Efficacy Of Risperdal� (Risperidone) Versus Placebo As Add-On Therapy To Mood Stabilizers In The Treatment Of The Manic Phase Of Bipolar Disorder

The purpose of the study is to evaluate the effectiveness and safety of risperidone (an antipsychotic medication) versus placebo as add-on therapy to mood stabilizers, in the treatment of manic episodes associated with bipolar disorder.

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. Antipsychotic drugs like risperidone have also been used as therapeutic agents in the treatment of patients who are not responsive to mood stabilizers alone. This is a randomized, double-blind study to evaluate the effectiveness and safety of risperidone compared with placebo, as an addition to mood stabilizing drugs, in the treatment of patients experiencing manic episodes associated with bipolar disorder. The study has two phases: a double-blind treatment phase (3 weeks) and an open-label phase (10 weeks). To participate in the study, patients must be in-patients for a minimum of the first 4 days of double-blind treatment. During the double-blind treatment phase, patients receive risperidone or placebo tablets to be taken once a day at gradually increasing doses at investigator's discretion, up to a maximum dose of 6 mg/day, while continuing their treatment with a mood stabilizer (lithium, valproate, or carbamazepine). In the open-label phase, therapy with a mood stabilizer continues, and all patients receive risperidone with dosage gradually adjusted to achieve optimal effectiveness. The primary measure of effectiveness is the change in Young Mania Rating Scale (YMRS) total score from baseline to end of double-blind treatment. Additional efficacy measures include the Brief Psychiatric Rating Scale (BPRS), the Clinical Global Impression (CGI), (which evaluates the change in severity of the disorder), and the Hamilton Depression Rating Scale (HAMD). Safety assessments include the incidence of adverse events throughout the study; measurement of vital signs (pulse and blood pressure) and 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) before study initiation, at completion of the double-blind treatment, and at the end of the study. The study hypothesis is that daily treatment with risperidone as add-on therapy provides better effectiveness than the addition of placebo, as measured by Young Mania Rating Scale scores, in the treatment of the manic phase of bipolar disorder. Risperidone 1 mg tablets, taken orally, once daily; Doses of 2 mg on Days 1 and 2, up to 4 mg on Days 3 and 4, and up to 6 mg (maximum dose) on Days 5 through 21. Same dose maintained through the 10 week open-label phase. Gradual dose adjustments are allowed to achieve optimal effectiveness.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Bipolar Disorder
  • Manic Disorder
Drug: risperidone
Not Provided
Yatham LN, Grossman F, Augustyns I, Vieta E, Ravindran A. Mood stabilisers plus risperidone or placebo in the treatment of acute mania. International, double-blind, randomised controlled trial. Br J Psychiatry. 2003 Feb;182:141-7. Erratum in: Br J Psychiatry. 2003 Apr;182:369.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
151
November 1999
Not Provided

Inclusion Criteria:

  • Patients hospitalized for mania with a score >=20 on the Young Mania Rating Scale (YMRS). (Patients with symptoms of depression are eligible)
  • diagnosis of Bipolar Disorder according to Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV)
  • receiving treatment with a mood stabilizer for a minimum of 2 weeks prior to study initiation, or beginning therapy with a mood stabilizer prior to treatment with study medication
  • patients medically stable on the basis of physical examination, medical history and electrocardiogram results.

Exclusion Criteria:

  • Other Axis I DSM-IV diagnosis (except nicotine or caffeine dependence)
  • history of alcohol or drug abuse or dependence within 3 months of starting the study
  • seizure disorder requiring medication
  • known sensitivity to risperidone, lithium, valproate or carbamazepine
  • pregnant or nursing females, or those lacking adequate contraception.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00250367
CR006058
Not Provided
Not Provided
Janssen Pharmaceutica N.V., Belgium
Not Provided
Study Director: Janssen Pharmaceutica N.V. Clinical Trial Janssen Pharmaceutica N.V.
Janssen Pharmaceutica N.V., Belgium
November 2010

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