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

5. desember 2011 oppdatert av: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

630

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35205
        • Innovative Clinical Trials, LLC
      • Birmingham, Alabama, Forente stater, 35242
        • Greystone Medical Research
    • Arizona
      • Scottsdale, Arizona, Forente stater, 85251
        • Scottsdale Family Health
      • Sun City, Arizona, Forente stater, 85351
        • Sun Valley Medical
      • Tucson, Arizona, Forente stater, 85711
        • Southwest Biomedical Research Foundation
    • California
      • Burbank, California, Forente stater, 91506
        • Southwestern Research Institute
      • Inglewood, California, Forente stater, 90301
        • Chrishard Clinical Research
      • La Mesa, California, Forente stater, 91942
        • Optimum Health Services
      • Los Angeles, California, Forente stater, 90024
        • Pacific Insititute for Medical Research
      • Oceanside, California, Forente stater, 92056
        • Optimum Health Services
      • Riverside, California, Forente stater, 92506
        • Behavioral Health 2000, LLC
      • San Diego, California, Forente stater, 92103
        • nTouch Research
    • Connecticut
      • New London, Connecticut, Forente stater, 06320
        • Psychiatric Medicine Center
    • Delaware
      • Newark, Delaware, Forente stater, 19702
        • Glasgow Family Practice
    • Florida
      • Ft. Lauderdale, Florida, Forente stater, 33311
        • Leonard Bass, MD, PA
      • Gainesville, Florida, Forente stater, 32607
        • Sarkis Clinical Trials
      • Jacksonville, Florida, Forente stater, 32257
        • Roger Miller, MD
      • North Miami, Florida, Forente stater, 33161
        • BioQuan Research Group, Inc.
      • St. Cloud, Florida, Forente stater, 34769
        • Family Practice - St. Cloud
    • Illinois
      • Arlington Heights, Illinois, Forente stater, 60005
        • Allan B. Aven, MD
      • Naperville, Illinois, Forente stater, 60542
        • nTouch Research - Chicago
      • Peoria, Illinois, Forente stater, 61614
        • Balanced Health Research Center
      • Peoria, Illinois, Forente stater, 61602
        • nTouch Research - Peoria
    • Indiana
      • Avon, Indiana, Forente stater, 46123
        • American Health Network
      • Evansville, Indiana, Forente stater, 47714
        • Research Solutions - Evansville
      • Indianapolis, Indiana, Forente stater, 46260
        • Amy Kaissar, MD
      • Terre Haute, Indiana, Forente stater, 47802
        • Clinco
    • Kentucky
      • Florence, Kentucky, Forente stater, 41042
        • Hartford Research Group
    • Louisiana
      • Metairie, Louisiana, Forente stater, 70001
        • New Orleans Medical Institute
      • Shreveport, Louisiana, Forente stater, 71101
        • Brentwood Research Institute
    • Michigan
      • Cadillac, Michigan, Forente stater, 49601
        • Professional Clinical Research at Great Lakes Family Care
    • Missouri
      • St. Louis, Missouri, Forente stater, 63125
        • Sam Hawatmeh, MD, PC
    • Nebraska
      • Alliance, Nebraska, Forente stater, 69301
        • Alliance Medical Center, PC
    • New Jersey
      • Glendora, New Jersey, Forente stater, 08029
        • Clinical Trial Associates
      • Turnersville, New Jersey, Forente stater, 08012
        • Partners in Primary Care
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 81709
        • ABQ Med., P.C.
    • New York
      • New York, New York, Forente stater, 10021
        • Eastside Comprehensive Medical Services, LLC
    • North Carolina
      • Raleigh, North Carolina, Forente stater, 27609
        • Raleigh Medical Group
      • Winston Salem, North Carolina, Forente stater, 27103
        • Salem Research Group
    • Ohio
      • Canal Fulton, Ohio, Forente stater, 44614
        • Community Health Care, Inc.
      • Cincinnati, Ohio, Forente stater, 45224
        • Hightop Medical Research Center
      • Cincinnati, Ohio, Forente stater, 45242
        • CFP Research, Inc.
      • Cincinnati, Ohio, Forente stater, 45219
        • Community Research Management Associates, Inc.
      • Dayton, Ohio, Forente stater, 45406
        • Martin Schear, MD
      • Wadsworth, Ohio, Forente stater, 44281
        • Family Practice Center of Wadsworth
    • Oklahoma
      • Edmond, Oklahoma, Forente stater, 73013
        • Sooner Clinical Research
      • Moore, Oklahoma, Forente stater, 73160
        • Med-line Research
      • Oklahoma City, Oklahoma, Forente stater, 73120
        • Cutting Edge Research Group
    • Oregon
      • Eugene, Oregon, Forente stater, 97401
        • Advanced Clinical Trials
      • Medford, Oregon, Forente stater, 97504
        • Medford Medical Clinic, LLP
      • Medford, Oregon, Forente stater, 97504
        • Clinical Research Consultants/Providence Medical
    • Pennsylvania
      • Downingtown, Pennsylvania, Forente stater, 19335
        • Gateway Medical
      • Feasterville, Pennsylvania, Forente stater, 19053
        • Feasterville Family Health Care
      • Lansdale, Pennsylvania, Forente stater, 19446
        • Detweiler Family Medicine
      • Lansdale, Pennsylvania, Forente stater, 19466
        • Green & Seidner Family Practice
      • Levittown, Pennsylvania, Forente stater, 19057
        • Woodburne Family Practice
      • Norristown, Pennsylvania, Forente stater, 19401
        • Pearl Clinical Research
      • Philadelphia, Pennsylvania, Forente stater, 19152
        • Joseph Rybicki, MD
      • Pittsburgh, Pennsylvania, Forente stater, 15206
        • Clinical Trials Research Services, LLC
      • Pittsburgh, Pennsylvania, Forente stater, 15221
        • Consolidated Clinical Trials, Inc.
      • Pottstown, Pennsylvania, Forente stater, 19465
        • Charles Buttz, MD
      • Reading, Pennsylvania, Forente stater, 19606
        • Research Across America
    • South Carolina
      • Greer, South Carolina, Forente stater, 29651
        • The Family Practice
    • Tennessee
      • Johnson City, Tennessee, Forente stater, 37601
        • Harmony Clinical Research
    • Texas
      • Beaumont, Texas, Forente stater, 77701
        • DiscoveResearch, Inc.
      • Corpus Christi, Texas, Forente stater, 78411
        • South Texas Applied Research
    • Virginia
      • Richmond, Virginia, Forente stater, 23294
        • International Clinical Research Associates, LLC
      • Virgina Beach, Virginia, Forente stater, 23452
        • International Clinical Research Associates
    • Washington
      • Kirkland, Washington, Forente stater, 98034
        • Richard Neiman, MD
      • Spokane, Washington, Forente stater, 99216
        • Daniel Blizzard, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Hva måler studien?

Primære resultatmål

Resultatmål
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.

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Samarbeidspartnere

Janssen, LP

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2004

Studiet fullført (Faktiske)

1. november 2005

Datoer for studieregistrering

Først innsendt

1. november 2004

Først innsendt som oppfylte QC-kriteriene

29. oktober 2004

Først lagt ut (Anslag)

1. november 2004

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

6. desember 2011

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. desember 2011

Sist bekreftet

1. desember 2011

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CR004726

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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