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

• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00095134
• Collaborator: Janssen, LP (Industry)
• Enrollment: 630
• Locations: 70
• Duration (Months): 13
• Patients Per Site: 9
• Patients Per Site Per Month: 0.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: risperidone	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 630 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A Double-Blind Study Comparing Adjunctive Risperidone Versus Placebo in Major Depressive Disorder That Is Not Responding to Standard Therapy
• Study Start Date: Oct 1, 2004
• Actual Study Completion Date: Nov 1, 2005

Outcome Measures

Primary Outcome Measures

1. 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

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Innovative Clinical Trials, LLC	Birmingham	Alabama	United States	35205
2	Greystone Medical Research	Birmingham	Alabama	United States	35242
3	Scottsdale Family Health	Scottsdale	Arizona	United States	85251
4	Sun Valley Medical	Sun City	Arizona	United States	85351
5	Southwest Biomedical Research Foundation	Tucson	Arizona	United States	85711
6	Southwestern Research Institute	Burbank	California	United States	91506
7	Chrishard Clinical Research	Inglewood	California	United States	90301
8	Optimum Health Services	La Mesa	California	United States	91942
9	Pacific Insititute for Medical Research	Los Angeles	California	United States	90024
10	Optimum Health Services	Oceanside	California	United States	92056
11	Behavioral Health 2000, LLC	Riverside	California	United States	92506
12	nTouch Research	San Diego	California	United States	92103
13	Psychiatric Medicine Center	New London	Connecticut	United States	06320
14	Glasgow Family Practice	Newark	Delaware	United States	19702
15	Leonard Bass, MD, PA	Ft. Lauderdale	Florida	United States	33311
16	Sarkis Clinical Trials	Gainesville	Florida	United States	32607
17	Roger Miller, MD	Jacksonville	Florida	United States	32257
18	BioQuan Research Group, Inc.	North Miami	Florida	United States	33161
19	Family Practice - St. Cloud	St. Cloud	Florida	United States	34769
20	Allan B. Aven, MD	Arlington Heights	Illinois	United States	60005
21	nTouch Research - Chicago	Naperville	Illinois	United States	60542
22	nTouch Research - Peoria	Peoria	Illinois	United States	61602
23	Balanced Health Research Center	Peoria	Illinois	United States	61614
24	American Health Network	Avon	Indiana	United States	46123
25	Research Solutions - Evansville	Evansville	Indiana	United States	47714
26	Amy Kaissar, MD	Indianapolis	Indiana	United States	46260
27	Clinco	Terre Haute	Indiana	United States	47802
28	Hartford Research Group	Florence	Kentucky	United States	41042
29	New Orleans Medical Institute	Metairie	Louisiana	United States	70001
30	Brentwood Research Institute	Shreveport	Louisiana	United States	71101
31	Professional Clinical Research at Great Lakes Family Care	Cadillac	Michigan	United States	49601
32	Sam Hawatmeh, MD, PC	St. Louis	Missouri	United States	63125
33	Alliance Medical Center, PC	Alliance	Nebraska	United States	69301
34	Clinical Trial Associates	Glendora	New Jersey	United States	08029
35	Partners in Primary Care	Turnersville	New Jersey	United States	08012
36	ABQ Med., P.C.	Albuquerque	New Mexico	United States	81709
37	Eastside Comprehensive Medical Services, LLC	New York	New York	United States	10021
38	Raleigh Medical Group	Raleigh	North Carolina	United States	27609
39	Salem Research Group	Winston Salem	North Carolina	United States	27103
40	Community Health Care, Inc.	Canal Fulton	Ohio	United States	44614
41	Community Research Management Associates, Inc.	Cincinnati	Ohio	United States	45219
42	Hightop Medical Research Center	Cincinnati	Ohio	United States	45224
43	CFP Research, Inc.	Cincinnati	Ohio	United States	45242
44	Martin Schear, MD	Dayton	Ohio	United States	45406
45	Family Practice Center of Wadsworth	Wadsworth	Ohio	United States	44281
46	Sooner Clinical Research	Edmond	Oklahoma	United States	73013
47	Med-line Research	Moore	Oklahoma	United States	73160
48	Cutting Edge Research Group	Oklahoma City	Oklahoma	United States	73120
49	Advanced Clinical Trials	Eugene	Oregon	United States	97401
50	Clinical Research Consultants/Providence Medical	Medford	Oregon	United States	97504
51	Medford Medical Clinic, LLP	Medford	Oregon	United States	97504
52	Gateway Medical	Downingtown	Pennsylvania	United States	19335
53	Feasterville Family Health Care	Feasterville	Pennsylvania	United States	19053
54	Detweiler Family Medicine	Lansdale	Pennsylvania	United States	19446
55	Green & Seidner Family Practice	Lansdale	Pennsylvania	United States	19466
56	Woodburne Family Practice	Levittown	Pennsylvania	United States	19057
57	Pearl Clinical Research	Norristown	Pennsylvania	United States	19401
58	Joseph Rybicki, MD	Philadelphia	Pennsylvania	United States	19152
59	Clinical Trials Research Services, LLC	Pittsburgh	Pennsylvania	United States	15206
60	Consolidated Clinical Trials, Inc.	Pittsburgh	Pennsylvania	United States	15221
61	Charles Buttz, MD	Pottstown	Pennsylvania	United States	19465
62	Research Across America	Reading	Pennsylvania	United States	19606
63	The Family Practice	Greer	South Carolina	United States	29651
64	Harmony Clinical Research	Johnson City	Tennessee	United States	37601
65	DiscoveResearch, Inc.	Beaumont	Texas	United States	77701
66	South Texas Applied Research	Corpus Christi	Texas	United States	78411
67	International Clinical Research Associates, LLC	Richmond	Virginia	United States	23294
68	International Clinical Research Associates	Virgina Beach	Virginia	United States	23452
69	Richard Neiman, MD	Kirkland	Washington	United States	98034
70	Daniel Blizzard, MD	Spokane	Washington	United States	99216

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00095134
• Other Study ID Numbers: CR004726
• First Posted: Nov 1, 2004
• Last Update Posted: Dec 6, 2011
• Last Verified: Dec 1, 2011

• Additional relevant MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major; Risperidone

Study Results

No Results Posted as of Dec 6, 2011