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

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: risperidone

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 Type: Interventional
• Enrollment (Actual): 630
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Innovative Clinical Trials, LLC
    • Birmingham, Alabama, United States, 35242
      • Greystone Medical Research
  • Arizona
    • Scottsdale, Arizona, United States, 85251
      • Scottsdale Family Health
    • Sun City, Arizona, United States, 85351
      • Sun Valley Medical
    • Tucson, Arizona, United States, 85711
      • Southwest Biomedical Research Foundation
  • California
    • Burbank, California, United States, 91506
      • Southwestern Research Institute
    • Inglewood, California, United States, 90301
      • Chrishard Clinical Research
    • La Mesa, California, United States, 91942
      • Optimum Health Services
    • Los Angeles, California, United States, 90024
      • Pacific Insititute for Medical Research
    • Oceanside, California, United States, 92056
      • Optimum Health Services
    • Riverside, California, United States, 92506
      • Behavioral Health 2000, LLC
    • San Diego, California, United States, 92103
      • nTouch Research
  • Connecticut
    • New London, Connecticut, United States, 06320
      • Psychiatric Medicine Center
  • Delaware
    • Newark, Delaware, United States, 19702
      • Glasgow Family Practice
  • Florida
    • Ft. Lauderdale, Florida, United States, 33311
      • Leonard Bass, MD, PA
    • Gainesville, Florida, United States, 32607
      • Sarkis Clinical Trials
    • Jacksonville, Florida, United States, 32257
      • Roger Miller, MD
    • North Miami, Florida, United States, 33161
      • BioQuan Research Group, Inc.
    • St. Cloud, Florida, United States, 34769
      • Family Practice - St. Cloud
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Allan B. Aven, MD
    • Naperville, Illinois, United States, 60542
      • nTouch Research - Chicago
    • Peoria, Illinois, United States, 61614
      • Balanced Health Research Center
    • Peoria, Illinois, United States, 61602
      • nTouch Research - Peoria
  • Indiana
    • Avon, Indiana, United States, 46123
      • American Health Network
    • Evansville, Indiana, United States, 47714
      • Research Solutions - Evansville
    • Indianapolis, Indiana, United States, 46260
      • Amy Kaissar, MD
    • Terre Haute, Indiana, United States, 47802
      • Clinco
  • Kentucky
    • Florence, Kentucky, United States, 41042
      • Hartford Research Group
  • Louisiana
    • Metairie, Louisiana, United States, 70001
      • New Orleans Medical Institute
    • Shreveport, Louisiana, United States, 71101
      • Brentwood Research Institute
  • Michigan
    • Cadillac, Michigan, United States, 49601
      • Professional Clinical Research at Great Lakes Family Care
  • Missouri
    • St. Louis, Missouri, United States, 63125
      • Sam Hawatmeh, MD, PC
  • Nebraska
    • Alliance, Nebraska, United States, 69301
      • Alliance Medical Center, PC
  • New Jersey
    • Glendora, New Jersey, United States, 08029
      • Clinical Trial Associates
    • Turnersville, New Jersey, United States, 08012
      • Partners in Primary Care
  • New Mexico
    • Albuquerque, New Mexico, United States, 81709
      • ABQ Med., P.C.
  • New York
    • New York, New York, United States, 10021
      • Eastside Comprehensive Medical Services, LLC
  • North Carolina
    • Raleigh, North Carolina, United States, 27609
      • Raleigh Medical Group
    • Winston Salem, North Carolina, United States, 27103
      • Salem Research Group
  • Ohio
    • Canal Fulton, Ohio, United States, 44614
      • Community Health Care, Inc.
    • Cincinnati, Ohio, United States, 45224
      • Hightop Medical Research Center
    • Cincinnati, Ohio, United States, 45242
      • CFP Research, Inc.
    • Cincinnati, Ohio, United States, 45219
      • Community Research Management Associates, Inc.
    • Dayton, Ohio, United States, 45406
      • Martin Schear, MD
    • Wadsworth, Ohio, United States, 44281
      • Family Practice Center of Wadsworth
  • Oklahoma
    • Edmond, Oklahoma, United States, 73013
      • Sooner Clinical Research
    • Moore, Oklahoma, United States, 73160
      • Med-line Research
    • Oklahoma City, Oklahoma, United States, 73120
      • Cutting Edge Research Group
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Advanced Clinical Trials
    • Medford, Oregon, United States, 97504
      • Medford Medical Clinic, LLP
    • Medford, Oregon, United States, 97504
      • Clinical Research Consultants/Providence Medical
  • Pennsylvania
    • Downingtown, Pennsylvania, United States, 19335
      • Gateway Medical
    • Feasterville, Pennsylvania, United States, 19053
      • Feasterville Family Health Care
    • Lansdale, Pennsylvania, United States, 19446
      • Detweiler Family Medicine
    • Lansdale, Pennsylvania, United States, 19466
      • Green & Seidner Family Practice
    • Levittown, Pennsylvania, United States, 19057
      • Woodburne Family Practice
    • Norristown, Pennsylvania, United States, 19401
      • Pearl Clinical Research
    • Philadelphia, Pennsylvania, United States, 19152
      • Joseph Rybicki, MD
    • Pittsburgh, Pennsylvania, United States, 15206
      • Clinical Trials Research Services, LLC
    • Pittsburgh, Pennsylvania, United States, 15221
      • Consolidated Clinical Trials, Inc.
    • Pottstown, Pennsylvania, United States, 19465
      • Charles Buttz, MD
    • Reading, Pennsylvania, United States, 19606
      • Research Across America
  • South Carolina
    • Greer, South Carolina, United States, 29651
      • The Family Practice
  • Tennessee
    • Johnson City, Tennessee, United States, 37601
      • Harmony Clinical Research
  • Texas
    • Beaumont, Texas, United States, 77701
      • DiscoveResearch, Inc.
    • Corpus Christi, Texas, United States, 78411
      • South Texas Applied Research
  • Virginia
    • Richmond, Virginia, United States, 23294
      • International Clinical Research Associates, LLC
    • Virgina Beach, Virginia, United States, 23452
      • International Clinical Research Associates
  • Washington
    • Kirkland, Washington, United States, 98034
      • Richard Neiman, MD
    • Spokane, Washington, United States, 99216
      • Daniel Blizzard, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

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

Collaborators and Investigators

• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborators: Janssen, LP

Publications and helpful links

General Publications

• Pandina G, Turkoz I, Bossie C. Impact of self-reported juvenile abuse on treatment outcome in patients with major depressive disorder. J Affect Disord. 2013 Oct;151(1):384-91. doi: 10.1016/j.jad.2013.01.053. Epub 2013 Jul 10.
• Mahmoud RA, Pandina GJ, Turkoz I, Kosik-Gonzalez C, Canuso CM, Kujawa MJ, Gharabawi-Garibaldi GM. Risperidone for treatment-refractory major depressive disorder: a randomized trial. Ann Intern Med. 2007 Nov 6;147(9):593-602. doi: 10.7326/0003-4819-147-9-200711060-00003.

Study record dates

Study Major Dates

• Study Start: October 1, 2004
• Study Completion (Actual): November 1, 2005

Study Registration Dates

• First Submitted: November 1, 2004
• First Submitted That Met QC Criteria: October 29, 2004
• First Posted (Estimate): November 1, 2004

Study Record Updates

• Last Update Posted (Estimate): December 6, 2011
• Last Update Submitted That Met QC Criteria: December 5, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Risperidone
• Other Study ID Numbers: CR004726