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


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Depersonalization disorder

Clinical Trial: Study Comparing Adjunctive Risperidone versus Placebo in Major Depressive Disorder That Is Not Responding to Standard Therapy

This study is currently recruiting patients.

Sponsored by: Janssen Pharmaceutica
Information provided by: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

Purpose

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 Treatment or Intervention Phase
Major Depressive Disorder
  Drug: risperidone
 Phase III

MedlinePlus related topics:  Mental Health

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Further Study Details: 

Expected Total Enrollment:  630

Study start: October 2004;  Expected completion: July 2005

Eligibility

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

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)

Location and Contact Information


Alabama
      Innovative Clinical Trials, LLC, Birmingham,  Alabama,  35205,  United States; Recruiting
Melanese Leonard  205-397-1280    ictrials@aol.com 
Mitchel Touger, MD,  Principal Investigator

      Greystone Medical Research, Birmingham,  Alabama,  35242,  United States; Recruiting
Lynn Friday  205-995-2260    gmresearch@msn.com 
David Wilhelm, MD,  Principal Investigator

Arizona
      Scottsdale Family Health, Scottsdale,  Arizona,  85251,  United States; Recruiting
Sheryl Schreck  480-945-3873    jlillo3@cox.net 
Joseph Lillo, DO,  Principal Investigator

      Sun Valley Medical, Sun City,  Arizona,  85351,  United States; Recruiting
Gina Gill  623-977-3300    satpreetsgill@hotmail.com 
Satpreet Gill, MD,  Principal Investigator

      Southwest Biomedical Research Foundation, Tucson,  Arizona,  85711,  United States; Recruiting
Gordon Hope  520-750-0861    bpsyresearch@aol.com 
Steven Bupp, MD,  Principal Investigator

California
      Pacific Insititute for Medical Research, Los Angeles,  California,  90024,  United States; Recruiting
Tanya Vapnik, Ph.D.  310-208-7144    tvapnik@mednet.ucla.edu 
Tanya Vapnik, MD,  Principal Investigator

      Behavioral Health 2000, LLC, Riverside,  California,  92506,  United States; Recruiting
Susan Lester  909-684-9905    slester@behavioralhealth2000.com 
Joachim Raese, MD,  Principal Investigator

      Southwestern Research Institute, Burbank,  California,  91506,  United States; Recruiting
Ryan Sakiyama  818-260-9080 
Brock Summers, MD,  Principal Investigator

      Optimum Health Services, Oceanside,  California,  92056,  United States; Recruiting
Dave Brull  760-631-3056    brull@ohresearch.com 
Valentin Isacescu, MD,  Principal Investigator

      Optimum Health Services, La Mesa,  California,  91942,  United States; Recruiting
Brian Norton  619-667-4567    norton@ohsresearch.com 
Gregory Paniccia, MD,  Principal Investigator

      nTouch Research, San Diego,  California,  92103,  United States; Recruiting
Anthony Mattorano  619-291-2845    bmiller@ntouchresearch.com 
William Shapiro, MD,  Principal Investigator

      Chrishard Clinical Research, Inglewood,  California,  90301,  United States; Recruiting
Sam Ghattas, MD  310-412-4716    samghmd@yahoo.com 
Cranford Scott, MD,  Principal Investigator

Connecticut
      Psychiatric Medicine Center, New London,  Connecticut,  06320,  United States; Recruiting
Nancy Fagan, RN  860-442-1983    pmchfc@aol.com 
Henry Crabbe, MD,  Principal Investigator

Delaware
      Glasgow Family Practice, Newark,  Delaware,  19702,  United States; Recruiting
Leslie Gill  302-836-8200 
Julio Navarro, MD,  Principal Investigator

Florida
      Sarkis Clinical Trials, Gainesville,  Florida,  32607,  United States; Recruiting
Jorge Franchesci, MSH, CCRC  352-333-0094    jorge@drsarkis.com 
Michael Johnson, MD,  Principal Investigator

      BioQuan Research Group, Inc., North Miami,  Florida,  33161,  United States; Recruiting
Lizet DiBernardo  305-981-7666    ferrislizz@aol.com 
Serge Vilvar, MD,  Principal Investigator

      Leonard Bass, MD, PA, Ft. Lauderdale,  Florida,  33311,  United States; Recruiting
Annie Clavon  954-484-9590 
Leonard Bass, MD,  Principal Investigator

      Roger Miller, MD, Jacksonville,  Florida,  32257,  United States; Recruiting
Sarah Desuyo  904-260-8552 
Roger Miller, MD,  Principal Investigator

      Family Practice - St. Cloud, St. Cloud,  Florida,  34769,  United States; Recruiting
Brenda denDulk  407-892-0009    researchstcloud@hotmail.com 
Charles Powers, MD,  Principal Investigator

Illinois
      Allan B. Aven, MD, Arlington Heights,  Illinois,  60005,  United States; Recruiting
Carol Tietz  847-253-1070    allanBA@aol.com 
Allan Aven, MD,  Principal Investigator

      nTouch Research - Peoria, Peoria,  Illinois,  61602,  United States; Recruiting
Amanda Foster  309-672-1910  Ext. 104    jfillmore@ntouchresearch.com 
Daniel Brune, MD,  Principal Investigator

      Balanced Health Research Center, Peoria,  Illinois,  61614,  United States; Recruiting
Kimberly Harris, RN, BSN  309-692-0797    drrebeccaknight@aol.com 
Rebecca Knight, MD,  Principal Investigator

      nTouch Research - Chicago, Naperville,  Illinois,  60542,  United States; Recruiting
Adrienne Reaves  708-364-7360    jcunnar@dupagefamilymedicine.com 
James Cunnar, MD,  Principal Investigator

Indiana
      Amy Kaissar, MD, Indianapolis,  Indiana,  46260,  United States; Recruiting
Amy Kaissar, MD  317-870-2230    gkaissar@comcast.net 
Amy Kaissar, MD,  Principal Investigator

      Research Solutions - Evansville, Evansville,  Indiana,  47714,  United States; Recruiting
Jana Morris  501-221-5000    jmorris@researchsolutionscorp.com 
Mohammed Allaw, MD,  Principal Investigator

      Clinco, Terre Haute,  Indiana,  47802,  United States; Recruiting
Amy Larimer  812-234-4899    clinco47802@yahoo.com 
Paras Harshawat, MD,  Principal Investigator

      American Health Network, Avon,  Indiana,  46123,  United States; Recruiting
Brittany Thomas  317-718-5479 
Ronald Stegemoller, MD,  Principal Investigator

Kentucky
      Hartford Research Group, Florence,  Kentucky,  41042,  United States; Recruiting
Terri Popovitz  859-525-8700    tpopovitz@aol.com 
James Hartford, MD,  Principal Investigator

Louisiana
      Brentwood Research Institute, Shreveport,  Louisiana,  71101,  United States; Recruiting
Brian Wooten  318-227-4552    brian@brentwoodresearch.com 
Guy Brannon, MD,  Principal Investigator

      New Orleans Medical Institute, Metairie,  Louisiana,  70001,  United States; Recruiting
Bernadette Di Toro  504-888-7425    bditoro@gminstitutes.com 
Robert Detrinis, MD,  Principal Investigator

Michigan
      Professional Clinical Research at Great Lakes Family Care, Cadillac,  Michigan,  49601,  United States; Recruiting
Johanna Lucas  231-779-9170    pcrcad@charter.mi.net 
William George, MD,  Principal Investigator

Missouri
      Sam Hawatmeh, MD, PC, St. Louis,  Missouri,  63125,  United States; Recruiting
Tandi Clark  314-631-2030 
Humam Farah, MD,  Principal Investigator

Nebraska
      Alliance Medical Center, PC, Alliance,  Nebraska,  69301,  United States; Recruiting
Julie Garrett  308-762-7300    vcampbell@odysseyresearch.org 
Bruce Forney, MD,  Principal Investigator

New Jersey
      Partners in Primary Care, Turnersville,  New Jersey,  08012,  United States; Recruiting
Maria Kassal, RN  856-228-3583    ppcresearch@earthlink.net 
Robert Direnzo, MD,  Principal Investigator

      Clinical Trial Associates, Glendora,  New Jersey,  08029,  United States; Recruiting
Andrea Dean  856-939-5058 
Benjamin Blank, MD,  Principal Investigator

New Mexico
      ABQ Med., P.C., Albuquerque,  New Mexico,  81709,  United States; Recruiting
Jessica Wallace  505-883-4016    kkbordenave@lobo.net 
Kristine Bordenave, MD,  Principal Investigator

New York
      Eastside Comprehensive Medical Services, LLC, New York,  New York,  10021,  United States; Recruiting
Johanna Landinez  212-288-0138    eastsidemed@aol.com 
Ram Shrivastava, MD,  Principal Investigator

North Carolina
      Raleigh Medical Group, Raleigh,  North Carolina,  27609,  United States; Recruiting
Angie Barefoot, LPN  919-341-3613    bgoldman@raleighmedicalgroup.com 
Brian Goldman, MD,  Principal Investigator

      Salem Research Group, Winston Salem,  North Carolina,  27103,  United States; Recruiting
Adrianna Fulda  336-760-3909    afulda@salemresearch.com 
Robert Rosen, MD,  Principal Investigator

Ohio
      Hightop Medical Research Center, Cincinnati,  Ohio,  45224,  United States; Recruiting
Linda Fidelholtz, RN  513-681-0606    hightop@one.net 
James Fidelholtz, MD,  Principal Investigator

      Family Practice Center of Wadsworth, Wadsworth,  Ohio,  44281,  United States; Recruiting
Pat Walker  330-334-6229    pwalker@wadsnet.com 
Matthew Finneran, MD,  Principal Investigator

      Community Health Care, Inc., Canal Fulton,  Ohio,  44614,  United States; Recruiting
Tammy Lincoln  330-854-4574    tammylincoln@hotmail.com 
Rodney Ison, MD,  Principal Investigator

      Community Research Management Associates, Inc., Cincinnati,  Ohio,  45219,  United States; Recruiting
Greg Maraan  513-721-3868    gmaraan@zoomtown.com 
Alfredo Rivera, MD,  Principal Investigator

      Martin Schear, MD, Dayton,  Ohio,  45406,  United States; Recruiting
Tami Caro, PA-C  937-276-4311    daytonclinical@aol.com 
Martin Schear, MD,  Principal Investigator

      CFP Research, Inc., Cincinnati,  Ohio,  45242,  United States; Recruiting
Myrna Sanders  513-794-0583    CFPResearch@aol.com 
William Cox, MD,  Principal Investigator

Oklahoma
      Sooner Clinical Research, Edmond,  Oklahoma,  73013,  United States; Recruiting
Kurt Smith, MA  405-843-0374    klssmi@ix.netcom.com 
Donald Denmark, MD,  Principal Investigator

      Cutting Edge Research Group, Oklahoma City,  Oklahoma,  73120,  United States; Recruiting
Judy Nation  405-751-8113    cuttingedgeresearch@hotmail.com 
Willis Holloway, MD,  Principal Investigator

      Med-line Research, Moore,  Oklahoma,  73160,  United States; Recruiting
Mary Melott  405-317-4891    mary.melott@sbcglobal.net 
Keith Layne, DO,  Principal Investigator

Oregon
      Advanced Clinical Trials, Eugene,  Oregon,  97401,  United States; Recruiting
Connie Spiller, RN  541-338-9252    actspearl@msn.com 
Marie Buscemi, MD,  Principal Investigator

      Medford Medical Clinic, LLP, Medford,  Oregon,  97504,  United States; Recruiting
John Hibner  541-734-3560    hibnerj@medfordmd.com 
Edward Cullen, MD,  Principal Investigator

      Clinical Research Consultants/Providence Medical, Medford,  Oregon,  97504,  United States; Recruiting
Robin Mishler  541-245-9022    researchdepartment@earthlink.net 
Michael Robinson, MD,  Principal Investigator

Pennsylvania
      Green & Seidner Family Practice, Lansdale,  Pennsylvania,  19466,  United States; Recruiting
Sam Ghattas, MD  310-412-4716    samghmd@yahoo.com 
Michael Seidner, MD,  Principal Investigator

      Gateway Medical, Downingtown,  Pennsylvania,  19335,  United States; Recruiting
Bernice Burgess  610-269-9448    bburgess@gatewaydoctors.com 
Geoffrey Burgess, MD,  Principal Investigator

      Charles Buttz, MD, Pottstown,  Pennsylvania,  19465,  United States; Recruiting
Debbie Larson  610-323-6835    deborah_larson@chs.net 
Charles Buttz, MD,  Principal Investigator

      Consolidated Clinical Trials, Inc., Pittsburgh,  Pennsylvania,  15221,  United States; Recruiting
Suzanne Holbach  412-273-9100    smh@consolidatedclinicaltrials.com 
Daniel Crable, MD,  Principal Investigator

      Pearl Clinical Research, Norristown,  Pennsylvania,  19401,  United States; Recruiting
Suzanne Bolger  610-270-9571 
Robert Pearlstein, MD,  Principal Investigator

      Research Across America, Reading,  Pennsylvania,  19606,  United States; Recruiting
Gaye Corbin  610-779-7061    infopa@researchacrossamerica.com 
Michael Warren, MD,  Principal Investigator

      Woodburne Family Practice, Levittown,  Pennsylvania,  19057,  United States; Recruiting
Rhoda Pomerantz  215-945-2210 
Christine Zador-Silverman, DO,  Principal Investigator

      Clinical Trials Research Services, LLC, Pittsburgh,  Pennsylvania,  15206,  United States; Recruiting
Johnie Champ  412-363-1900    jchamp@ctrsllc.com 
Ben Zimmer, MD,  Principal Investigator

      Detweiler Family Medicine, Lansdale,  Pennsylvania,  19446,  United States; Recruiting
Diane Barndt  215-368-1900  Ext. 24    dfm2000@aol.com 
Robert Detweiler, MD,  Principal Investigator

      Joseph Rybicki, MD, Philadelphia,  Pennsylvania,  19152,  United States; Recruiting
Kathy Reichner  215-673-8806    rybsfam6@aol.com 
Joseph Rybicki, MD,  Principal Investigator

      Feasterville Family Health Care, Feasterville,  Pennsylvania,  19053,  United States; Recruiting
Mary Ann Cave  215-355-9770    mcave@amn.org 
John Penniston, MD,  Principal Investigator

South Carolina
      The Family Practice, Greer,  South Carolina,  29651,  United States; Recruiting
Sheila Vogan, RN  864-848-9293    tfpresearch@aol.com 
Ronald DeGarmo, MD,  Principal Investigator

Tennessee
      Harmony Clinical Research, Johnson City,  Tennessee,  37601,  United States; Recruiting
Kathy Harmon  423-283-8850    kathyharmon@harmonyclinicalresearch.com 
Curtis Kauffmann, MD,  Principal Investigator

Texas
      DiscoveResearch, Inc., Beaumont,  Texas,  77701,  United States; Recruiting
Karla Hall  979-779-3303    sciman@tca.net 
Stephen Braden, MD,  Principal Investigator

      DiscoveResearch, Inc., Beaumont,  Texas,  77701,  United States; Recruiting
Matt Bullock, BS, CCRC  818-842-4863    drimbmt@aol.com 
Maria Blahey, MD,  Principal Investigator

      South Texas Applied Research, Corpus Christi,  Texas,  78411,  United States; Recruiting
Laura Stephens  361-814-2223    STARLJT1@aol.com 
Gerard Boynton, MD,  Principal Investigator

Virginia
      International Clinical Research Associates, LLC, Richmond,  Virginia,  23294,  United States; Recruiting
Carol Gilliam  804-270-6811    carolinegilliam@msn.com 
John Gilliam, MD,  Principal Investigator

      International Clinical Research Associates, VIrgina Beach,  Virginia,  23452,  United States; Recruiting
Tanya Astorga  757-368-0672    tanya.astorga@prodigy.net 
William Yetter, MD,  Principal Investigator

Washington
      Daniel Blizzard, MD, Spokane,  Washington,  99216,  United States; Recruiting
Janet Caudill  509-922-1462    drblizzard@hotmail.com 
Daniel Blizzard, MD,  Principal Investigator

      Richard Neiman, MD, Kirkland,  Washington,  98034,  United States; Recruiting
Sandy Laurence  425-899-1667    gscal99@comcast.net 
Richard Neiman, MD,  Principal Investigator

More Information

Study ID Numbers:  RIS-DEP-401
Record last reviewed:  November 2004
Last Updated:  November 17, 2004
Record first received:  November 1, 2004
ClinicalTrials.gov Identifier:  NCT00095134
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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Page Updated: October 1, 2005
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