Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Janssen, LP |
---|---|
Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00095134 |
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.
Condition | Intervention | Phase |
---|---|---|
Major Depressive Disorder |
Drug: risperidone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind Study Comparing Adjunctive Risperidone Versus Placebo in Major Depressive Disorder That Is Not Responding to Standard Therapy |
Estimated Enrollment: | 630 |
Study Start Date: | October 2004 |
Estimated Study Completion Date: | March 2006 |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CR004726 |
Study First Received: | November 1, 2004 |
Last Updated: | September 13, 2005 |
ClinicalTrials.gov Identifier: | NCT00095134 |
Health Authority: | United States: Food and Drug Administration |
Dopamine Depression Mental Disorders Risperidone Mood Disorders |
Depressive Disorder, Major Depressive Disorder Serotonin Behavioral Symptoms |
Neurotransmitter Agents Disease Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Dopamine Antagonists |
Antipsychotic Agents Pharmacologic Actions Serotonin Antagonists Pathologic Processes Serotonin Agents Therapeutic Uses Dopamine Agents Central Nervous System Agents |