Study Comparing Risperidone vs Placebo as add-on Therapy in Patients With Generalized Anxiety Disorder Who Are Sub-optimally Responding to Standard Therapy.

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Janssen, LP
• Treatments: Risperidone

Criteria

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