Status:

COMPLETED

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

Lead Sponsor:

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

Collaborating Sponsors:

Janssen, LP

Conditions:

Anxiety Disorders

Eligibility:

All Genders

18-65 years

Phase:

PHASE3

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 trea...

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 effec...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2005

Estimated Enrollment :

301 Patients enrolled

Trial Details

Trial ID

NCT00086112

End Date

June 1 2005

Last Update

July 23 2012

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