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A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-3 Study

31. maj 2019 opdateret af: Alkermes, Inc.

A Phase 3 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder (the FORWARD-3 Study)

This study will evaluate the efficacy and safety of ALKS 5461.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

447

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Bulgarien
      • Bourgas, Bulgarien, 8001
        • Alkermes Investigational Site
      • Kazanlak, Bulgarien, 6100
        • Alkermes Investigational Site
      • Sofia, Bulgarien, 1113
        • Alkermes Investigational Site
      • Sofia, Bulgarien, 1431
        • Alkermes Investigational Site
      • Sofia, Bulgarien, 1632
        • Alkermes Investigational Site
      • Varna, Bulgarien, 9020
        • Alkermes Investigational Site
      • Veliko Tarnovo, Bulgarien, 5000
        • Alkermes Investigational Site
      • Vratza, Bulgarien, 3000
        • Alkermes Investigational Site
  • Forenede Stater
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72211
        • Alkermes Investigational Site
    • California
      • Bellflower, California, Forenede Stater, 90706
        • Alkermes Investigational Site
      • Beverly Hills, California, Forenede Stater, 90210
        • Alkermes Investigational Site
      • Glendale, California, Forenede Stater, 91206
        • Alkermes Investigational Site
      • Los Alamitos, California, Forenede Stater, 90720
        • Alkermes Investigational Site
      • Orange, California, Forenede Stater, 92868
        • Alkermes Investigational Site
      • Redlands, California, Forenede Stater, 92374
        • Alkermes Investigational Site
      • Temecula, California, Forenede Stater, 92591
        • Alkermes Investigational Site
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20016
        • Alkermes Investigational Site
    • Florida
      • Hallandale Beach, Florida, Forenede Stater, 33009
        • Alkermes Investigational Site
      • Hialeah, Florida, Forenede Stater, 33016
        • Alkermes Investigational Site
      • Jacksonville, Florida, Forenede Stater, 32256
        • Alkermes Investigational Site
      • Leesburg, Florida, Forenede Stater, 34748
        • Alkermes Investigational Site
      • Maitland, Florida, Forenede Stater, 32751
        • Alkermes Investigational Site
      • Tampa, Florida, Forenede Stater, 33613
        • Alkermes Investigational Site
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30331
        • Alkermes Investigational Site
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60634
        • Alkermes Investigational Site
      • Oak Brook, Illinois, Forenede Stater, 60523
        • Alkermes Investigational Site
      • Vernon Hills, Illinois, Forenede Stater, 60061
        • Alkermes Investigational Site
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46260
        • Alkermes Investigational Site
      • Lafayette, Indiana, Forenede Stater, 47905
        • Alkermes Investigational Site
    • Kentucky
      • Edgewood, Kentucky, Forenede Stater, 41017
        • Alkermes Investigational Site
    • Maryland
      • Washington DC, Maryland, Forenede Stater, 20016
        • Alkermes Investigational
    • Massachusetts
      • Brockton, Massachusetts, Forenede Stater, 02301
        • Alkermes Investigational Site
      • Watertown, Massachusetts, Forenede Stater, 02472
        • Alkermes Investigational Site
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64114
        • Alkermes Investigational Site
      • O'Fallon, Missouri, Forenede Stater, 63368
        • Alkermes Investigational Site
      • Saint Louis, Missouri, Forenede Stater, 63109
        • Alkermes Investigational Site
    • New Jersey
      • Cherry Hill, New Jersey, Forenede Stater, 08002
        • Alkermes Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87109
        • Alkermes Investigational Site
    • New York
      • Jamaica, New York, Forenede Stater, 11432
        • Alkermes Investigational Site
      • New York, New York, Forenede Stater, 10023
        • Alkermes Investigational Site
      • Staten Island, New York, Forenede Stater, 10312
        • Alkermes Investigational Site
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28204
        • Alkermes Investigational Site
    • Ohio
      • Beachwood, Ohio, Forenede Stater, 44122
        • Alkermes Investigational Site
      • Cincinnati, Ohio, Forenede Stater, 45215
        • Alkermes Investigational Site
      • Cincinnati, Ohio, Forenede Stater, 45227
        • Alkermes Investigational Site
      • Mason, Ohio, Forenede Stater, 45040
        • Alkermes Investigational Site
      • Middleburg Heights, Ohio, Forenede Stater, 44130
        • Alkermes Investigational Site
    • Oregon
      • Portland, Oregon, Forenede Stater, 97210
        • Alkermes Investigational Site
      • Salem, Oregon, Forenede Stater, 97301
        • Alkermes Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Alkermes Investigational Site
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29407
        • Alkermes Investigational Site
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38119
        • Alkermes Investigational Site
    • Texas
      • Dallas, Texas, Forenede Stater, 75231
        • Alkermes Investigational Site
      • Dallas, Texas, Forenede Stater, 75309
        • Alkermes Investigational Site
      • Houston, Texas, Forenede Stater, 77098
        • Alkermes Investigational Site
      • Sugar Land, Texas, Forenede Stater, 77478
        • Alkermes Investigational Site
    • Washington
      • Bellevue, Washington, Forenede Stater, 98007
        • Alkermes Investigational Site
    • Wisconsin
      • Waukesha, Wisconsin, Forenede Stater, 53188
        • Alkermes Investigational Site

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

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Have a Body Mass Index (BMI) of 18.0 to 40.0 kg/m2, inclusive
  • Agree to use an acceptable method of contraception for the duration of the study
  • Have a Major Depressive Disorder (MDD) primary diagnosis
  • Have no more than 2 inadequate responses to antidepressant therapy (ADT) in the current Major Depressive Episode (MDE)
  • Additional criteria may apply

Exclusion Criteria:

  • Have a current primary Axis-I disorder other than MDD
  • Have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days
  • Have received electroconvulsive therapy treatment within the last 2 years or received more than one course of electroconvulsive treatment during lifetime
  • Have attempted suicide within the past 2 years
  • Have a positive test for drugs of abuse
  • Are pregnant, planning to become pregnant, or breastfeeding
  • Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone)
  • Have had a significant blood loss or blood donation within 60 days
  • Additional criteria may apply

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Medicin: Placebo
Sublingual tablet, taget én gang dagligt (ud over åben behandling med et kommercielt tilgængeligt antidepressivum)
Eksperimentel: ALKS 5461
Medicin: ALKS 5461
Sublingual tablet, taget én gang dagligt (ud over åben behandling med et kommercielt tilgængeligt antidepressivum)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline to End of Treatment (Week 6) in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score
Tidsramme: Baseline and week 6
The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts.
Baseline and week 6

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of Patients Who Exhibited Treatment Response (MADRS-10)
Tidsramme: 6 weeks
The proportion of subjects demonstrating MADRS-10 treatment response, defined as a ≥ 50% reduction in MADRS-10 score from baseline to the end of the efficacy period (week 6).
6 weeks
Remission Rate
Tidsramme: 6 weeks
The proportion of subjects achieving remission, defined as a MADRS-10 score of ≤ 10 at the end of the efficacy period.
6 weeks
Number of Subjects With Adverse Events (AEs)
Tidsramme: 6 weeks
6 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Alkermes, Inc.

Efterforskere

  • Studieleder: Sanjeev Pathak, MD, Alkermes, Inc.

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

1. maj 2014

Primær færdiggørelse (Faktiske)

1. december 2015

Studieafslutning (Faktiske)

1. december 2015

Datoer for studieregistrering

Først indsendt

5. juni 2014

Først indsendt, der opfyldte QC-kriterier

5. juni 2014

Først opslået (Skøn)

9. juni 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. juni 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. maj 2019

Sidst verificeret

1. maj 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ALK5461-206

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 ALKS 5461

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Congo

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner