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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
risperidone
Sponsored by
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Innovative Clinical Trials, LLC
  • Greystone Medical Research
  • Scottsdale Family Health
  • Sun Valley Medical
  • Southwest Biomedical Research Foundation
  • Southwestern Research Institute
  • Chrishard Clinical Research
  • Optimum Health Services
  • Pacific Insititute for Medical Research
  • Optimum Health Services
  • Behavioral Health 2000, LLC
  • nTouch Research
  • Psychiatric Medicine Center
  • Glasgow Family Practice
  • Leonard Bass, MD, PA
  • Sarkis Clinical Trials
  • Roger Miller, MD
  • BioQuan Research Group, Inc.
  • Family Practice - St. Cloud
  • Allan B. Aven, MD
  • nTouch Research - Chicago
  • nTouch Research - Peoria
  • Balanced Health Research Center
  • American Health Network
  • Research Solutions - Evansville
  • Amy Kaissar, MD
  • Clinco
  • Hartford Research Group
  • New Orleans Medical Institute
  • Brentwood Research Institute
  • Professional Clinical Research at Great Lakes Family Care
  • Sam Hawatmeh, MD, PC
  • Alliance Medical Center, PC
  • Clinical Trial Associates
  • Partners in Primary Care
  • ABQ Med., P.C.
  • Eastside Comprehensive Medical Services, LLC
  • Raleigh Medical Group
  • Salem Research Group
  • Community Health Care, Inc.
  • Community Research Management Associates, Inc.
  • Hightop Medical Research Center
  • CFP Research, Inc.
  • Martin Schear, MD
  • Family Practice Center of Wadsworth
  • Sooner Clinical Research
  • Med-line Research
  • Cutting Edge Research Group
  • Advanced Clinical Trials
  • Clinical Research Consultants/Providence Medical
  • Medford Medical Clinic, LLP
  • Gateway Medical
  • Feasterville Family Health Care
  • Detweiler Family Medicine
  • Green & Seidner Family Practice
  • Woodburne Family Practice
  • Pearl Clinical Research
  • Joseph Rybicki, MD
  • Clinical Trials Research Services, LLC
  • Consolidated Clinical Trials, Inc.
  • Charles Buttz, MD
  • Research Across America
  • The Family Practice
  • Harmony Clinical Research
  • DiscoveResearch, Inc.
  • South Texas Applied Research
  • International Clinical Research Associates, LLC
  • International Clinical Research Associates
  • Richard Neiman, MD
  • Daniel Blizzard, MD

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
November 1, 2004
Last Updated
December 5, 2011
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators
Janssen, LP
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1. Study Identification

Unique Protocol Identification Number
NCT00095134
Brief Title
Study Comparing Adjunctive Risperidone Versus Placebo in Major Depressive Disorder That Is Not Responding to Standard Therapy
Official Title
A Double-Blind Study Comparing Adjunctive Risperidone Versus Placebo in Major Depressive Disorder That Is Not Responding to Standard Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators
Janssen, LP

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
630 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
risperidone
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Safety will be assessed through reported adverse events and vital signs (weight, blood pressure, pulse, and temperature).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Innovative Clinical Trials, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Greystone Medical Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35242
Country
United States
Facility Name
Scottsdale Family Health
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Sun Valley Medical
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Southwest Biomedical Research Foundation
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
Southwestern Research Institute
City
Burbank
State/Province
California
ZIP/Postal Code
91506
Country
United States
Facility Name
Chrishard Clinical Research
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
Optimum Health Services
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Pacific Insititute for Medical Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Optimum Health Services
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Behavioral Health 2000, LLC
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
nTouch Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Psychiatric Medicine Center
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
Facility Name
Glasgow Family Practice
City
Newark
State/Province
Delaware
ZIP/Postal Code
19702
Country
United States
Facility Name
Leonard Bass, MD, PA
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33311
Country
United States
Facility Name
Sarkis Clinical Trials
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Roger Miller, MD
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32257
Country
United States
Facility Name
BioQuan Research Group, Inc.
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Family Practice - St. Cloud
City
St. Cloud
State/Province
Florida
ZIP/Postal Code
34769
Country
United States
Facility Name
Allan B. Aven, MD
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
nTouch Research - Chicago
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60542
Country
United States
Facility Name
nTouch Research - Peoria
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
Balanced Health Research Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
American Health Network
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Facility Name
Research Solutions - Evansville
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Amy Kaissar, MD
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Clinco
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47802
Country
United States
Facility Name
Hartford Research Group
City
Florence
State/Province
Kentucky
ZIP/Postal Code
41042
Country
United States
Facility Name
New Orleans Medical Institute
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70001
Country
United States
Facility Name
Brentwood Research Institute
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Professional Clinical Research at Great Lakes Family Care
City
Cadillac
State/Province
Michigan
ZIP/Postal Code
49601
Country
United States
Facility Name
Sam Hawatmeh, MD, PC
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63125
Country
United States
Facility Name
Alliance Medical Center, PC
City
Alliance
State/Province
Nebraska
ZIP/Postal Code
69301
Country
United States
Facility Name
Clinical Trial Associates
City
Glendora
State/Province
New Jersey
ZIP/Postal Code
08029
Country
United States
Facility Name
Partners in Primary Care
City
Turnersville
State/Province
New Jersey
ZIP/Postal Code
08012
Country
United States
Facility Name
ABQ Med., P.C.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
81709
Country
United States
Facility Name
Eastside Comprehensive Medical Services, LLC
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Raleigh Medical Group
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Salem Research Group
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Community Health Care, Inc.
City
Canal Fulton
State/Province
Ohio
ZIP/Postal Code
44614
Country
United States
Facility Name
Community Research Management Associates, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Hightop Medical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45224
Country
United States
Facility Name
CFP Research, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Martin Schear, MD
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406
Country
United States
Facility Name
Family Practice Center of Wadsworth
City
Wadsworth
State/Province
Ohio
ZIP/Postal Code
44281
Country
United States
Facility Name
Sooner Clinical Research
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73013
Country
United States
Facility Name
Med-line Research
City
Moore
State/Province
Oklahoma
ZIP/Postal Code
73160
Country
United States
Facility Name
Cutting Edge Research Group
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Advanced Clinical Trials
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Clinical Research Consultants/Providence Medical
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Medford Medical Clinic, LLP
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Gateway Medical
City
Downingtown
State/Province
Pennsylvania
ZIP/Postal Code
19335
Country
United States
Facility Name
Feasterville Family Health Care
City
Feasterville
State/Province
Pennsylvania
ZIP/Postal Code
19053
Country
United States
Facility Name
Detweiler Family Medicine
City
Lansdale
State/Province
Pennsylvania
ZIP/Postal Code
19446
Country
United States
Facility Name
Green & Seidner Family Practice
City
Lansdale
State/Province
Pennsylvania
ZIP/Postal Code
19466
Country
United States
Facility Name
Woodburne Family Practice
City
Levittown
State/Province
Pennsylvania
ZIP/Postal Code
19057
Country
United States
Facility Name
Pearl Clinical Research
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19401
Country
United States
Facility Name
Joseph Rybicki, MD
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19152
Country
United States
Facility Name
Clinical Trials Research Services, LLC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
Facility Name
Consolidated Clinical Trials, Inc.
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15221
Country
United States
Facility Name
Charles Buttz, MD
City
Pottstown
State/Province
Pennsylvania
ZIP/Postal Code
19465
Country
United States
Facility Name
Research Across America
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19606
Country
United States
Facility Name
The Family Practice
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Harmony Clinical Research
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37601
Country
United States
Facility Name
DiscoveResearch, Inc.
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77701
Country
United States
Facility Name
South Texas Applied Research
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78411
Country
United States
Facility Name
International Clinical Research Associates, LLC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
International Clinical Research Associates
City
Virgina Beach
State/Province
Virginia
ZIP/Postal Code
23452
Country
United States
Facility Name
Richard Neiman, MD
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
Daniel Blizzard, MD
City
Spokane
State/Province
Washington
ZIP/Postal Code
99216
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23849714
Citation
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.
Results Reference
derived
PubMed Identifier
17975181
Citation
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.
Results Reference
derived

Learn more about this trial

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

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