Study Comparing Adjunctive Risperidone Versus Placebo in Major Depressive Disorder That Is Not Responding to Standard Therapy
|First Received Date ICMJE||November 1, 2004|
|Last Updated Date||December 5, 2011|
|Start Date ICMJE||October 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Difference in therapeutic effect of risperidone and placebo as measured by change in depression rating scale (HAM-D) at end of week 4 of the double-blind phase.|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00095134 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Safety will be assessed through reported adverse events and vital signs (weight, blood pressure, pulse, and temperature).|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Study Comparing Adjunctive Risperidone Versus Placebo in Major Depressive Disorder That Is Not Responding to Standard Therapy|
|Official Title ICMJE||A Double-Blind Study Comparing Adjunctive Risperidone Versus Placebo in Major Depressive Disorder That Is Not Responding to Standard Therapy|
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.
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 of adjunctive treatment with risperidone in patients with MDD who failed to adequately respond to standard antidepressant treatment prior to this trial and who prospectively do not respond to adequate treatment with standard antidepressant therapy (SAD).
Patients entering the open label phase of the study will have already taken a commercially available SAD for a minimum of 4 weeks, and provided the dose was optimal, will continue on this dose of SAD throughout the four-week open-label and six-week double-blind phases of the trial.
If the dose in the four weeks prior to entering the study was not optimal (as per standard clinical practice), the dose will be increased to be within the optimal range and continued at that dose through the entire open-label SAD and double-blind phases.
During the double-blind phase, subjects receive an adjunctive dose of risperidone or placebo, once daily, added to their stable dose of SAD. The starting dose of risperidone or placebo is 0.25 mg for the first three days of the double-blind phase, and is increased to 0.5 mg for days 4 through 14. On the 15th day of this phase, the dose is increased to the target dose of 1.0 mg/day. If response to this dose is not optimal by day 29, it is increased to 2.0 mg/day and is maintained for the duration of the 6-week double-blind phase. This dose may be reduced once to 1.0 mg/day, but then must be maintained at that dose for the remainder of the study.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Condition ICMJE||Major Depressive Disorder|
|Intervention ICMJE||Drug: risperidone|
|Study Arm (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||November 2005|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 65 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00095134|
|Other Study ID Numbers ICMJE||CR004726|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|
|Collaborators ICMJE||Janssen, LP|
|Investigators ICMJE||Not Provided|
|Information Provided By||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|
|Verification Date||December 2011|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP