Status:
COMPLETED
Study Comparing Adjunctive Risperidone Versus Placebo in Major Depressive Disorder That Is Not Responding to Standard Therapy
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Janssen, LP
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this trial is to evaluate the efficacy and safety of risperidone versus placebo in subjects with Major Depressive Disorder with sub-optimal response to antidepressant therapy.
Detailed Description
Many patients who suffer from Major Depressive Disorder (MDD) do not benefit or show only partial benefit from current psychotropic therapy. This clinical trial seeks to study the efficacy and safety ...
Eligibility Criteria
Inclusion
- Understand and sign the informed consent form
- Age 18-65
- Healthy on the basis of Physical Exam
- Treatment with a single antidepressant 4 weeks prior to study start and willingness to maintain on stable dose of the same antidepressant throughout the study
- Current diagnosis of Major Depressive Disorder
- Judgement of the clinician that the subject has shown a sub-optimal response to the antidepressant
Exclusion
- Presence of other serious medical illness(es)
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
630 Patients enrolled
Trial Details
Trial ID
NCT00095134
Start Date
October 1 2004
End Date
November 1 2005
Last Update
December 6 2011
Active Locations (70)
Enter a location and click search to find clinical trials sorted by distance.
1
Innovative Clinical Trials, LLC
Birmingham, Alabama, United States, 35205
2
Greystone Medical Research
Birmingham, Alabama, United States, 35242
3
Scottsdale Family Health
Scottsdale, Arizona, United States, 85251
4
Sun Valley Medical
Sun City, Arizona, United States, 85351