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

NCT00253162 | Completed Phase 3

• 1 other identifier: CR006049
• Study Type: interventional
• Target: 439
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bipolar Disorders; Manic Disorder

Keywords

risperidone; antipsychotic agents; bipolar disorders; manic episode

Outcome Measures

Primary Outcomes (1)

• Acute efficacy: Change in Young Mania Rating Scale (YMRS) total score from baseline to endpoint of 3 weeks of acute treatment period.

Secondary Outcomes (1)

• 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

Interventions

risperidone DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Related Publications (1)

• 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. doi: 10.1016/j.euroneuro.2004.06.003.

  PMID: 15572276 RESULT

MeSH Terms

Conditions

Bipolar Disorder; Mania

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 10, 2005
• First Posted: November 15, 2005
• Study Start: March 1, 2001
• Study Completion: September 1, 2002
• Last Updated: January 28, 2011

Record last verified: 2011-01