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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00095134
• Other study ID #: CR004726
• Status: Completed
• Phase: Phase 3
• First received: November 1, 2004
• Last updated: December 5, 2011
• Start date: October 2004
• Est. completion date: November 2005

Study information

• Verified date: December 2011
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 630
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• risperidone

Locations

Country	Name	City	State
United States	ABQ Med., P.C.	Albuquerque	New Mexico
United States	Alliance Medical Center, PC	Alliance	Nebraska
United States	Allan B. Aven, MD	Arlington Heights	Illinois
United States	American Health Network	Avon	Indiana
United States	DiscoveResearch, Inc.	Beaumont	Texas
United States	Greystone Medical Research	Birmingham	Alabama
United States	Innovative Clinical Trials, LLC	Birmingham	Alabama
United States	Southwestern Research Institute	Burbank	California
United States	Professional Clinical Research at Great Lakes Family Care	Cadillac	Michigan
United States	Community Health Care, Inc.	Canal Fulton	Ohio
United States	CFP Research, Inc.	Cincinnati	Ohio
United States	Community Research Management Associates, Inc.	Cincinnati	Ohio
United States	Hightop Medical Research Center	Cincinnati	Ohio
United States	South Texas Applied Research	Corpus Christi	Texas
United States	Martin Schear, MD	Dayton	Ohio
United States	Gateway Medical	Downingtown	Pennsylvania
United States	Sooner Clinical Research	Edmond	Oklahoma
United States	Advanced Clinical Trials	Eugene	Oregon
United States	Research Solutions - Evansville	Evansville	Indiana
United States	Feasterville Family Health Care	Feasterville	Pennsylvania
United States	Hartford Research Group	Florence	Kentucky
United States	Leonard Bass, MD, PA	Ft. Lauderdale	Florida
United States	Sarkis Clinical Trials	Gainesville	Florida
United States	Clinical Trial Associates	Glendora	New Jersey
United States	The Family Practice	Greer	South Carolina
United States	Amy Kaissar, MD	Indianapolis	Indiana
United States	Chrishard Clinical Research	Inglewood	California
United States	Roger Miller, MD	Jacksonville	Florida
United States	Harmony Clinical Research	Johnson City	Tennessee
United States	Richard Neiman, MD	Kirkland	Washington
United States	Optimum Health Services	La Mesa	California
United States	Detweiler Family Medicine	Lansdale	Pennsylvania
United States	Green & Seidner Family Practice	Lansdale	Pennsylvania
United States	Woodburne Family Practice	Levittown	Pennsylvania
United States	Pacific Insititute for Medical Research	Los Angeles	California
United States	Clinical Research Consultants/Providence Medical	Medford	Oregon
United States	Medford Medical Clinic, LLP	Medford	Oregon
United States	New Orleans Medical Institute	Metairie	Louisiana
United States	Med-line Research	Moore	Oklahoma
United States	nTouch Research - Chicago	Naperville	Illinois
United States	Psychiatric Medicine Center	New London	Connecticut
United States	Eastside Comprehensive Medical Services, LLC	New York	New York
United States	Glasgow Family Practice	Newark	Delaware
United States	Pearl Clinical Research	Norristown	Pennsylvania
United States	BioQuan Research Group, Inc.	North Miami	Florida
United States	Optimum Health Services	Oceanside	California
United States	Cutting Edge Research Group	Oklahoma City	Oklahoma
United States	Balanced Health Research Center	Peoria	Illinois
United States	nTouch Research - Peoria	Peoria	Illinois
United States	Joseph Rybicki, MD	Philadelphia	Pennsylvania
United States	Clinical Trials Research Services, LLC	Pittsburgh	Pennsylvania
United States	Consolidated Clinical Trials, Inc.	Pittsburgh	Pennsylvania
United States	Charles Buttz, MD	Pottstown	Pennsylvania
United States	Raleigh Medical Group	Raleigh	North Carolina
United States	Research Across America	Reading	Pennsylvania
United States	International Clinical Research Associates, LLC	Richmond	Virginia
United States	Behavioral Health 2000, LLC	Riverside	California
United States	nTouch Research	San Diego	California
United States	Scottsdale Family Health	Scottsdale	Arizona
United States	Brentwood Research Institute	Shreveport	Louisiana
United States	Daniel Blizzard, MD	Spokane	Washington
United States	Family Practice - St. Cloud	St. Cloud	Florida
United States	Sam Hawatmeh, MD, PC	St. Louis	Missouri
United States	Sun Valley Medical	Sun City	Arizona
United States	Clinco	Terre Haute	Indiana
United States	Southwest Biomedical Research Foundation	Tucson	Arizona
United States	Partners in Primary Care	Turnersville	New Jersey
United States	International Clinical Research Associates	Virgina Beach	Virginia
United States	Family Practice Center of Wadsworth	Wadsworth	Ohio
United States	Salem Research Group	Winston Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Janssen, LP

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety will be assessed through reported adverse events and vital signs (weight, blood pressure, pulse, and temperature).