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A Safety and Effectiveness Study of JNJ-18038683 in Patients With Moderate to Severe Depression

1. august 2014 opdateret af: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

A Phase IIa Multicenter, Randomized, Double-blind, Double-dummy, and Placebo- and Active Controlled Study to Investigate the Safety and Efficacy of JNJ-18038683 Administered to Subjects With Major Depressive Disorder

The purpose of this study is to evaluate the safety and effectiveness of JNJ-18038683 compared to escitalopram and placebo in patients with moderate to severe depression.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study is being done to assess safety and tolerability and to explore the effectiveness of a new, experimental drug in the treatment of moderate to severe depression. Approximately 225 patients with depression will be recruited for the study. Patients who meet study criteria will need to stop taking any depression medications they are currently using. They will be randomly assigned to one of 3 treatment arms; each patient has an equal chance of receiving 20 mg JNJ-18038683, 20 mg escitalopram, or placebo. Placebo has no active drug. Escitalopram is a drug currently approved to treat depression. This is a blinded study, ie the patient, the study doctor, and the study sponsor will not know what treatment the patient receives until all patients complete the study. Patients receiving either escitalopram or JNJ-18038683 will be titrated up to their assigned dose, receiving 10 mg doses for one week prior to increasing to 20 mg. Patients who are not able to tolerate 20 mg of JNJ-18038683 will be allowed to drop down to the 10 mg dose at any time after the titration period. Patients taking 20 mg escitalopram will receive 10 mg at their final week to taper off of the drug. Patients will receive a drug blister card at each weekly visit containing drug for the upcoming week. The study doctor and the sponsor will monitor the study for the occurrence of possible side effects. In addition to a screening visit, patients will return weekly for 9 additional study visits. After completing the study, patients may resume other depression medications. Medical and psychiatric history, physical examination, blood pressure, heart rate, temperature, weight and electrocardiograms (ECGs) will be checked periodically. Blood samples will be taken for standard safety laboratory tests as well as for the measurement of the drug blood level. Questionnaires relating to depression, sleep and sexual experience will be administered throughout the study. Each day for nine weeks, patients will take orally two JNJ-18038683 tablets, active and/or placebo, and two escitalopram capsules, active and/or placebo.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

67

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater
    • California
      • Beverly Hills, California, Forenede Stater
      • Glendale, California, Forenede Stater
      • San Diego, California, Forenede Stater
    • Florida
      • Bradenton, Florida, Forenede Stater
      • Maitland, Florida, Forenede Stater
      • Orlando, Florida, Forenede Stater
    • Georgia
      • Atlanta, Georgia, Forenede Stater
    • Idaho
      • Eagle, Idaho, Forenede Stater
    • Illinois
      • Chicago, Illinois, Forenede Stater
    • Kansas
      • Prairie Village, Kansas, Forenede Stater
      • Topeka, Kansas, Forenede Stater
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater
      • Shreveport, Louisiana, Forenede Stater
    • New Jersey
      • Nutley, New Jersey, Forenede Stater
    • New York
      • Brooklyn, New York, Forenede Stater
      • Cedarhurst, New York, Forenede Stater
      • Fresh Meadows, New York, Forenede Stater
    • Ohio
      • Cincinnati, Ohio, Forenede Stater
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater
    • Oregon
      • Portland, Oregon, Forenede Stater
    • Pennsylvania
      • Norristown, Pennsylvania, Forenede Stater
    • Tennessee
      • Memphis, Tennessee, Forenede Stater
    • Texas
      • Austin, Texas, Forenede Stater
      • Irving, Texas, Forenede Stater
    • Virginia
      • Richmond, Virginia, Forenede Stater

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 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Diagnosed with moderate to severe major depressive disorder
  • Willing to use acceptable methods of birth control throughout the study and for 3 months after
  • In good general health

Exclusion Criteria:

  • No history or current diagnosis of other psychiatric conditions such as bipolar disorder, psychotic disorder, general anxiety disorder, anorexia, obsessive compulsive disorder, post traumatic stress disorder, antisocial personality disorder, mental retardation, pervasive developmental disorder, or cognitive disorder
  • No history or presence of drug abuse
  • No use of prescription medications or herbal medications other than hormone replacement therapies
  • No prior history of heart disease or current significant blood, lung, kidney, liver, heart, breathing, neurologic or thyroid disorders
  • No patients who are either pregnant or nursing

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: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Medicin: Placebo
Form= capsule, route= oral use. Administration once daily for 8 weeks.
Medicin: JNJ-18038683
Type= range, unit= mg, number= 10 to 20, form= capsule, route= oral use. Administration of 10 mg daily for 1 week, 10 or 20 mg daily for 6 weeks, and placebo daily for 1 week.
Aktiv komparator: Escitalopram
Medicin: Escitalopram
Type= range, unit= mg, number= 10 to 20, form= capsule, route= oral use. Administration of 10 mg daily for 1 week, 20 mg daily for 6 weeks, and 10 mg daily for 1 week.
Eksperimentel: JNJ-18038683
Medicin: Placebo
Form= capsule, route= oral use. Administration once daily for 8 weeks.
Medicin: JNJ-18038683
Type= range, unit= mg, number= 10 to 20, form= capsule, route= oral use. Administration of 10 mg daily for 1 week, 10 or 20 mg daily for 6 weeks, and placebo daily for 1 week.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Explore the effectiveness of JNJ-18038683 in patients with moderate to severe depression as determined by accepted clinical assessments done throughout the study.
Tidsramme: Clinical assessments to evaluate depression will be done 8 times at weekly visits from baseline through the Week 7 visit.
Clinical assessments to evaluate depression will be done 8 times at weekly visits from baseline through the Week 7 visit.

Sekundære resultatmål

Resultatmål
Tidsramme
Explore the safety and tolerability of JNJ-18038683 in patients with moderate to severe depression by assessing adverse events, vital signs, laboratory test results, ECGs and physical exams.
Tidsramme: Vital signs will be collected weekly throughout the study; ECGs will be collected at screening, baseline, Wks 3 and 7; Laboratory test will be collected at screening, baseline, and Wks 1,3,5,7 and 8. Adverse Events will be throughout the study.
Vital signs will be collected weekly throughout the study; ECGs will be collected at screening, baseline, Wks 3 and 7; Laboratory test will be collected at screening, baseline, and Wks 1,3,5,7 and 8. Adverse Events will be throughout the study.

Samarbejdspartnere og efterforskere

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

Sponsor

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

Efterforskere

  • Studieleder: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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. december 2007

Primær færdiggørelse (Faktiske)

1. december 2008

Studieafslutning (Faktiske)

1. december 2008

Datoer for studieregistrering

Først indsendt

29. november 2007

Først indsendt, der opfyldte QC-kriterier

29. november 2007

Først opslået (Skøn)

3. december 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. august 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. august 2014

Sidst verificeret

1. august 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CR014617
  • C-2007-007 (Anden identifikator: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.)

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 Placebo

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Nigeria

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner