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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.

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ClinicalTrials.gov Identifier: NCT00086112
Recruitment Status : Completed
First Posted : June 28, 2004
Last Update Posted : July 23, 2012
Sponsor:
Collaborator:
Janssen, LP
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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.

Condition or disease Intervention/treatment Phase
Anxiety Disorders Drug: risperidone oral tablets Phase 3

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  (Clinical Trial)
Actual Enrollment : 301 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Prospective Study to Evaluate Adjunctive Risperidone Versus Adjunctive Placebo in Generalized Anxiety Disorder Sub-optimally Responsive to Standard Psychotropic Therapy
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
Drug Information available for: Risperidone




Primary Outcome Measures :
  1. Change from baseline in a composite self-rating of the four most troubling symptoms identified at baseline.

Secondary Outcome Measures :
  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.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00086112


Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Janssen, LP
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00086112     History of Changes
Other Study ID Numbers: CR004696
First Posted: June 28, 2004    Key Record Dates
Last Update Posted: July 23, 2012
Last Verified: July 2012

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Anxiety
antipsychotic

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Pathologic Processes
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents