Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00086112
Status:
COMPLETED
Last Update Posted:
2012-07-23
First Post:
2004-06-24
Brief Title:
Study Comparing Risperidone vs Placebo as add-on Therapy in Patients With Generalized Anxiety Disorder Who Are Sub-optimally Responding to Standard Therapy
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 025 mg per day for the first 3 days 05 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 025 mg per day for the first 3 days 05 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
Risperidone 025 mg per day for the first 3 days 05 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None