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

10. september 2019 opdateret af: 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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

330

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

7 år til 17 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Vilazodone
Medicin: Vilazodone
Vilazodone tablets, once daily, oral administration
Andre navne:
  • Viibryd

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Forest Laboratories

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. maj 2015

Primær færdiggørelse (Faktiske)

23. juli 2018

Studieafslutning (Faktiske)

23. juli 2018

Datoer for studieregistrering

Først indsendt

28. april 2015

Først indsendt, der opfyldte QC-kriterier

1. maj 2015

Først opslået (Skøn)

6. maj 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. september 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. september 2019

Sidst verificeret

1. september 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • VLZ-MD-23

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Større depressiv lidelse

Kliniske forsøg med Vilazodone

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Lebanon

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner