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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety Disorders
• Intervention / Treatment: Drug: risperidone oral tablets

Detailed Description

Many patients with Generalized Anxiety Disorder (GAD) do not benefit or show only partial benefit from current psychotropic therapies. This trial was conducted for the purpose of determining the effectiveness of risperidone as an adjunctive treatment in patients with GAD who demonstrate a less-than-optimal response to their current anxiolytic treatment (either allowed antidepressants, benzodiazepines, or buspirone, or combination). Patients were randomized (patients are assigned different treatments based on chance) to either risperidone or placebo for 4 - 6 weeks of double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage) treatment. Patients randomized to risperidone continued on their current anxiolytic treatment (treatment for anxiety) and received risperidone 0.25 mg per day for the first 3 days, 0.5 mg per day for days 4 through 14, and 1 mg per day for days 15 through 28 of the trial. If clinically indicated, on day 29, the dose could be increased to 2 mg per day for the rest of the trial (4 to 6 additional weeks). At each dose level, risperidone was taken by mouth in a single daily dose. Patients were asked questions every one or two weeks, depending on the phase of the trial, to determine efficacy (effectiveness) and safety. The study hypothesis is that risperidone will be more effective as an adjunct to standard psychotropic treatments for symptoms of Generalized Anxiety Disorder than placebo, as measured by a composite of the four most troubling symptoms identified at baseline.

Risperidone 0.25 mg per day for the first 3 days, 0.5 mg per day for days 4 through 14, and 1 mg per day for days 15 through 28 of the trial. If clinically indicated, on day 29, the dose could be increased to 2 mg per day for the rest of the trial (4 to 6 additional weeks). At each dose level, risperidone was taken by mouth in a single daily dose.

• Study Type: Interventional
• Enrollment (Actual): 301
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from baseline in a composite self-rating of the four most troubling symptoms identified at baseline.

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborators: Janssen, LP

Publications and helpful links

General Publications

• 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.

Helpful Links

• Study on Adjunctive Risperidone therapy in Generalized Anxiety Disorder That Is Not Responding to Standard Therapy

Study record dates

Study Major Dates

• Study Completion (Actual): June 1, 2005

Study Registration Dates

• First Submitted: June 24, 2004
• First Submitted That Met QC Criteria: June 25, 2004
• First Posted (Estimate): June 28, 2004

Study Record Updates

• Last Update Posted (Estimate): July 23, 2012
• Last Update Submitted That Met QC Criteria: July 19, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Anxiety; antipsychotic
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Risperidone
• Other Study ID Numbers: CR004696