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A Study of Vilazodone in Pediatric Patients With Major Depressive Disorder (VLZ-MD-23)

10. september 2019 oppdatert av: Forest Laboratories

An Open-label Long-term Safety Study of Vilazodone in Pediatric Patients With Major Depressive Disorder

The purpose of this study is to evaluate the long-term safety and tolerability of vilazodone for the treatment of MDD in pediatric outpatients (7-17 years).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

330

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiesteder

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y1Z9
        • Okanagan Clinical Trials Inc.
    • Ontario
      • Toronto, Ontario, Canada, M6J3S3
        • Paediatric Sleep Research Inc
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35213
        • Alliance Clinical Research
      • Dothan, Alabama, Forente stater, 36303
        • Harmonex Neuroscience Research
    • Arizona
      • Phoenix, Arizona, Forente stater, 85016
        • Phoenix Children's Hospital
    • Arkansas
      • Little Rock, Arkansas, Forente stater, 72211
        • Woodland International Research Group, Inc
    • California
      • Bellflower, California, Forente stater, 90706
        • CITrials - Bellflower
      • Costa Mesa, California, Forente stater, 92626
        • ATP Clinical Research
      • Glendale, California, Forente stater, 91206
        • Behavioral Research Specialists, LLC
      • San Diego, California, Forente stater, 92108
        • PCSD - Feighner Research
    • Connecticut
      • Hartford, Connecticut, Forente stater, 06106
        • Pacific Clinical Research Medical Group
    • District of Columbia
      • Washington, District of Columbia, Forente stater, 20010
        • Children's National Medical Center
    • Florida
      • Hialeah, Florida, Forente stater, 33012
        • Palm Springs Research, LLC
      • Homestead, Florida, Forente stater, 33030
        • IMIC Inc.
      • Jacksonville, Florida, Forente stater, 32256
        • Clinical Neuroscience Solutions, Inc.
      • Lauderhill, Florida, Forente stater, 33319
        • Innovative Clinical Research, Inc.
      • Orlando, Florida, Forente stater, 32801
        • Clinical Neuroscience Solutions, Inc.
    • Georgia
      • Alpharetta, Georgia, Forente stater, 30005
        • Institute for Advanced Medical Research
      • Atlanta, Georgia, Forente stater, 30331
        • Atlantic Center for Medical Research
      • Marietta, Georgia, Forente stater, 30060
        • Northwest Behavioral Research Center
    • Illinois
      • Libertyville, Illinois, Forente stater, 60048
        • Capstone Clinical Research
      • Naperville, Illinois, Forente stater, 60563
        • Baber Research Group
      • Oak Park, Illinois, Forente stater, 60301
        • Neuroscience Research Institute Inc.
    • Kansas
      • Overland Park, Kansas, Forente stater, 66211
        • Psychiatric Associates
    • Louisiana
      • Lake Charles, Louisiana, Forente stater, 70629
        • Lake Charles Clinical Trials
    • Maryland
      • Baltimore, Maryland, Forente stater, 21205
        • Hugo W Moser Research Institute at Kennedy Krieger, Inc.
      • Baltimore, Maryland, Forente stater, 21208
        • Pharmsite Research Inc.
      • Rockville, Maryland, Forente stater, 20852
        • Neuroscientific Insights
    • Massachusetts
      • Springfield, Massachusetts, Forente stater, 01199
        • Baystate Medical Center
      • Watertown, Massachusetts, Forente stater, 02472
        • Adams Clinical Trials, LLC
    • Missouri
      • Creve Coeur, Missouri, Forente stater, 63141
        • Millennium Psychiatric Associates
      • Saint Charles, Missouri, Forente stater, 63304
        • St. Charles Psychiatric Associates - Midwest Research Group
    • New York
      • Buffalo, New York, Forente stater, 14215
        • Erie County Medical Center/State University of New York of Buffalo Affiliate
      • Mount Kisco, New York, Forente stater, 10549
        • Bioscience Research LLC
      • New York, New York, Forente stater, 10022
        • Manhattan Behavioral Medicine
      • Rochester, New York, Forente stater, 14618
        • Finger Lakes Clinical Research
      • Staten Island, New York, Forente stater, 10312
        • Richmond Behavioral Associates
    • Ohio
      • Avon Lake, Ohio, Forente stater, 44012
        • Haidar Almhana Nieding LLC
      • Canton, Ohio, Forente stater, 44718
        • Neuro-Behavioral Clinical Research, Inc
      • Cincinnati, Ohio, Forente stater, 45219
        • University of Cincinnati
      • Cleveland, Ohio, Forente stater, 44106
        • University Hospitals Cleveland Medical Center, Psychiatr
      • Columbus, Ohio, Forente stater, 43210
        • Ohio State Univ. Dept of Psychiatry
      • Mason, Ohio, Forente stater, 45040
        • Professional Psychiatric Services
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73103
        • IPS Research Company
      • Oklahoma City, Oklahoma, Forente stater, 73116
        • Cutting Edge Research Group
    • Tennessee
      • Memphis, Tennessee, Forente stater, 38119
        • Research Strategies of Memphis LLC
    • Texas
      • Austin, Texas, Forente stater, 78759
        • BioBehavioral Research of Austin, PC
      • Houston, Texas, Forente stater, 77054
        • UT Health Science Center at Houston
      • Houston, Texas, Forente stater, 77079
        • Houston Endoscopy and Research Ctr
      • Plano, Texas, Forente stater, 75093
        • Research Across America
      • San Antonio, Texas, Forente stater, 78229
        • Focus and Balance
      • The Woodlands, Texas, Forente stater, 77381
        • Family Psychiatry of The Woodlands
    • Utah
      • Clinton, Utah, Forente stater, 84015
        • Ericksen Research and Development
    • Virginia
      • Charlottesville, Virginia, Forente stater, 22903
        • UVA Center for Psychopharmacology Research in Youth
    • Washington
      • Bellevue, Washington, Forente stater, 98007
        • Northwest Clinical Research Center
      • Kirkland, Washington, Forente stater, 98033
        • Core Clinical Research

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

7 år til 17 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Male or Female outpatients betw een 7-17 years of age
  • Primary diagnosis of major depressive disorder (MDD)
  • Children's Depression Rating Scale-Revised (CDRS-R) score of 40 or greater
  • Clinical Global Impressions-Severity (CGI-S) score of 4 or greater

Exclusion Criteria:

  • Current (past 3 months) principal Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision based diagnosis of an Axis I disorder other than MDD that is the primary focus of treatment (de novo patients only)
  • History of suicidal behavior, or requires precaution against suicide
  • Not generally healthy medical condition
  • Seizure disorder

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: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Vilazodone
Legemiddel: Vilazodone
Vilazodone tablets, once daily, oral administration
Andre navn:
  • Viibryd

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants to Experience a Treatment Emergent Adverse Event (TEAE)
Tidsramme: Visit 1 (Week -1) to up to Visit 16 (Week 26)
The number of Participants who experienced a treatment emergent adverse events during the 27 week period from screening to the end of the open-label treatment period
Visit 1 (Week -1) to up to Visit 16 (Week 26)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in the CDRS-R Total Score
Tidsramme: Baseline (Week 0) to Week 26
The Children's Depression Rating Scale-Revised (CDRS-R) total score ranges from 17 (minimal or no symptoms of depression) to 133 (indicative of depression) is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 to 17 years of age and their caregivers. The CDRS-R evaluates the presence and severity of symptoms commonly associated with depression in childhood.
Baseline (Week 0) to Week 26
Change From Baseline in the CGI-S Score
Tidsramme: Baseline (Week 0) to Week 26
The Clinical Global Impressions-Severity (CGI-S) is a clinician-rated instrument used to rate the severity of the patient's current state of mental illness compared with the clinician's total experience with patients with major depressive disorder (MDD). The severity of the patient's MDD was rated on a scale from 1 to 7, with 1 indicating a normal state and 7 indicating a patient who is among the most extremely ill patients.
Baseline (Week 0) to Week 26
Change From Baseline in Clinical Global Impressions-Improvement (CGI-I)
Tidsramme: Baseline (Week 0) to Week 26
The Clinical Global Impressions-Improvement is a clinician-rated instrument that was used to rate total improvement or worsening of mental illness, regardless of whether the Investigator considered it to be a result of treatment with the investigational product. The CGI-I was used to rate the patient's improvement on a scale from 1 to 7, with 1 indicating that the patient was very much improved (with a score of 4 indicating no change) and 7 indicating the patient was very much worse.
Baseline (Week 0) to Week 26

Samarbeidspartnere og etterforskere

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

Sponsor

Forest Laboratories

Etterforskere

  • Studieleder: Emily McCusker, PhD, Forest Research Institute, Inc., an affiliate of Allergan, plc

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 (Faktiske)

2. mai 2015

Primær fullføring (Faktiske)

23. juli 2018

Studiet fullført (Faktiske)

23. juli 2018

Datoer for studieregistrering

Først innsendt

28. april 2015

Først innsendt som oppfylte QC-kriteriene

1. mai 2015

Først lagt ut (Anslag)

6. mai 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. september 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. september 2019

Sist bekreftet

1. september 2019

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • VLZ-MD-23

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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. .

Kliniske studier på Major depressiv lidelse

Kliniske studier på Vilazodone

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