A Study of the Effectiveness and Safety of Risperidone 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 Versus Haloperidol As Add-On Therapy To Mood Stabilizers In The Treatment Of The Manic Phase Of Bipolar Disorder
1 other identifier
interventional
158
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
April 1, 1999
CompletedFirst Submitted
Initial submission to the registry
November 10, 2005
CompletedFirst Posted
Study publicly available on registry
November 15, 2005
CompletedJanuary 24, 2011
January 1, 2011
November 10, 2005
January 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Young Mania Rating Scale (YMRS) total score from baseline to end of double-blind treatment
Secondary Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of Bipolar Disorder according to Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV)
- hospitalized for mania with a score \>=20 on the Young Mania Rating Scale (YMRS) (patients with concurrent symptoms of depression are eligible)
- inpatient for a minimum of the first 4 days of double-blind treatment
- therapy with lithium or valproate (mood stabilizers) at start of treatment with study medication
- medically stable on the basis of physical examination, medical history, and electrocardiogram results.
You may not qualify if:
- Other Axis I DSM-IV diagnosis (except nicotine or caffeine dependence)
- history of alcohol or drug abuse or dependence within 4 weeks of starting the study
- seizure disorder requiring medication
- known sensitivity to risperidone, haloperidol, lithium, valproate or carbamazepine
- pregnant or nursing females, or those lacking adequate contraception.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Sachs GS, Grossman F, Ghaemi SN, Okamoto A, Bowden CL. Combination of a mood stabilizer with risperidone or haloperidol for treatment of acute mania: a double-blind, placebo-controlled comparison of efficacy and safety. Am J Psychiatry. 2002 Jul;159(7):1146-54. doi: 10.1176/appi.ajp.159.7.1146.
PMID: 12091192RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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 Completion
April 1, 1999
Last Updated
January 24, 2011
Record last verified: 2011-01