Clinical trial NCT00095134: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
Collaborators: name: Janssen, LP
First posted: 2004-11-01
Enrollment: 630
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

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