Study Comparing Adjunctive Risperidone Versus Placebo in Major Depressive Disorder That Is Not Responding to Standard Therapy

Phase 3

Completed

• Conditions: Major Depressive Disorder

• Registration Number: NCT00095134
• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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 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 Timeline

• Study Start: 2004-10
• Study First Submitted QC: 2004-10-29
• Study First Submitted: 2004-11-01
• Study First Posted: 2004-11-01
• Study Completion: 2005-11
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-05
• Last Update Posted: 2011-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 630

Inclusion Criteria

• 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 Criteria

• Presence of other serious medical illness(es)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Safety will be assessed through reported adverse events and vital signs (weight, blood pressure, pulse, and temperature).

Trial Locations

Locations (69)

Innovative Clinical Trials, LLC; 🇺🇸 Birmingham, Alabama, United States

Greystone Medical Research; 🇺🇸 Birmingham, Alabama, United States

Scottsdale Family Health; 🇺🇸 Scottsdale, Arizona, United States

Sun Valley Medical; 🇺🇸 Sun City, Arizona, United States

Southwest Biomedical Research Foundation; 🇺🇸 Tucson, Arizona, United States

Southwestern Research Institute; 🇺🇸 Burbank, California, United States

Chrishard Clinical Research; 🇺🇸 Inglewood, California, United States

Optimum Health Services; 🇺🇸 Oceanside, California, United States

Pacific Insititute for Medical Research; 🇺🇸 Los Angeles, California, United States

Behavioral Health 2000, LLC; 🇺🇸 Riverside, California, United States

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