Study Comparing Risperidone vs Placebo as add-on Therapy in Patients With Generalized Anxiety Disorder Who Are Sub-optimally Responding to Standard Therapy.
A Double-blind, Randomized, Prospective Study to Evaluate Adjunctive Risperidone Versus Adjunctive Placebo in Generalized Anxiety Disorder Sub-optimally Responsive to Standard Psychotropic Therapy
1 other identifier
interventional
301
0 countries
N/A
Brief Summary
The purpose of this trial is to determine the effectiveness of risperidone as an adjunctive treatment in patients with GAD who demonstrate a less-than-optimal response to their current anxiolytic treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 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
First Submitted
Initial submission to the registry
June 24, 2004
CompletedFirst Posted
Study publicly available on registry
June 28, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2005
CompletedJuly 23, 2012
July 1, 2012
June 24, 2004
July 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in a composite self-rating of the four most troubling symptoms identified at baseline.
Secondary Outcomes (1)
Change from baseline and actual values for other efficacy variables (HAM-A, PGIS, CGI-S, SDS, and Q-LES-Q; safety assessment through adverse event reports, laboratory tests, vital signs, physical examinations, and concomitant medications.
Interventions
Eligibility Criteria
You may qualify if:
- Healthy on the basis of physical exam
- Treatment with one or more allowed antidepressants and/or anxiety medications for at least the past 8 weeks
- Judgement of the clinician that the patient has shown a sub-optimal response to this treatment
- Current diagnosis of Generalized Anxiety Disorder
- Maintained on a stable, therapeutic dose(s) of the allowed medication(s) for at least the past four weeks
You may not qualify if:
- Presence of other serious medical illnesses
- Active use of cocaine or heroin
- History of suicide attempt in past 12 months
- Changes to antidepressant/anti-anxiety regimen (medication or dose) within the four weeks preceding study baseline (Day 1)
- History of clozapine use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Pandina GJ, Canuso CM, Turkoz I, Kujawa M, Mahmoud RA. Adjunctive risperidone in the treatment of generalized anxiety disorder: a double-blind, prospective, placebo-controlled, randomized trial. Psychopharmacol Bull. 2007;40(3):41-57.
PMID: 18007568DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research and 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
June 24, 2004
First Posted
June 28, 2004
Study Completion
June 1, 2005
Last Updated
July 23, 2012
Record last verified: 2012-07