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Safety And Efficacy Of 12 Weeks Of Varenicline For Smoking Cessation In Smokers With Depression

6. marts 2013 opdateret af: Pfizer

A Phase 4 12-week, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating The Safety And Efficacy Of Varenicline Tartrate (CP-526,555) 1mg BID For Smoking Cessation In Subjects With Depression

Patients with depression tend to have a higher prevalence of smoking as well as increased severity of nicotine dependence. Phase 2 and Phase 3 varenicline clinical trials that demonstrated its efficacy and tolerability have not included subjects with depression. This smoking cessation study focuses on the depressed population and will assess the efficacy and safety of varenicline.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

525

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

  • Bosnien-Hercegovina
      • Banja Luka, Bosnien-Hercegovina, 78000
        • Psychiatric Clinic, Clinical Center Banja Luka
      • Sarajevo, Bosnien-Hercegovina, 71000
        • Clinic of Psychiatry, Clinical Center University of Sarajevo
  • Den Russiske Føderation
      • Moscow, Den Russiske Føderation, 107076
        • Federal State Institution Moscow Scientific Research Institute of Psychiatry of Roszdrav
      • Moscow, Den Russiske Føderation, 115522
        • Institution of Russian Academy of Medical Sciences Mental Health Research Center
      • Moscow, Den Russiske Føderation, 125367
        • Moscow State Healthcare Institution Clinical Mental Hospital No 12
      • St-Petersburg, Den Russiske Føderation, 190121
        • St-Petersburg State Healthcare Institution St. Nicholas Mental Hospital
  • Forenede Stater
    • California
      • Garden Grove, California, Forenede Stater, 92845
        • Collaborative Neuroscience Network, Inc.
      • Sherman Oaks, California, Forenede Stater, 91403
        • California Neuroscience Research Medical Group, Inc
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • Behavioral Health and Wellness Program, University of Colorado Denver
    • Connecticut
      • Norwich, Connecticut, Forenede Stater, 06360
        • Comprehensive Psychiatric Care
    • Florida
      • Fort Walton Beach, Florida, Forenede Stater, 32547
        • Emerald Coast Mood & Memory, PA
      • Jacksonville, Florida, Forenede Stater, 32216
        • Clinical Neuroscience Solutions Incorporated
      • Orlando, Florida, Forenede Stater, 32806
        • Clinical Neuroscience Solutions Incorporated
    • Kansas
      • Overland, Kansas, Forenede Stater, 66211
        • Vince and Associates Clinical Research
      • Overland Park, Kansas, Forenede Stater, 66212
        • Vince and Associates Clinical Research
      • Wichita, Kansas, Forenede Stater, 67207
        • Heartland Research Associates, LLC
    • Ohio
      • Beachwood, Ohio, Forenede Stater, 44122
        • NorthCoast Clinical Trials Inc.
      • Cincinnati, Ohio, Forenede Stater, 45219
        • University of Cincinnati
      • Cincinnati, Ohio, Forenede Stater, 45237
        • University of Cincinnati
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19139
        • CRI Worldwide LLC
    • Tennessee
      • Bartlett, Tennessee, Forenede Stater, 38134
        • Clinical Trials of Memphis
    • Texas
      • Austin, Texas, Forenede Stater, 78731
        • FutureSearch Trials
      • Houston, Texas, Forenede Stater, 77008
        • Claghorn-Lesem Research Clinic, Ltd.
  • Kroatien
      • Zagreb, Kroatien, 10000
        • "Poliklinika Neuron" - Croatian Institute for Brain Research
      • Zagreb, Kroatien, 10000
        • Psychiatric Hospital Vrapce
  • Rumænien
      • Bucuresti, Rumænien, 041902
        • Spitalul Clinic de Psihiatrie Prof. Dr. Al. Obregia, sectia 2
      • Iasi, Rumænien, 700282
        • Spitalul Clinic de Psihiatrie Socola, sectia VII
    • Sector 4
      • Bucuresti, Sector 4, Rumænien
        • Spitalul Psihiatrie "Prof. Dr. Al. Obregia"
  • Spanien
      • Barcelona, Spanien, 08025
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spanien, 08035
        • Hospital General de La Vall D'Hebron
      • Zaragoza, Spanien, 50007
        • Centro de Salud Torrero La Paz
    • Asturias
      • Oviedo, Asturias, Spanien, 33011
        • Centro de Salud Mental Ii "La Corredoria"
  • Tyskland
      • Freiburg, Tyskland, 79104
        • Universitaetsklinikum Freiburg
      • Muenchen, Tyskland, 80336
        • Ludwig Maximilians-Universitaet Muenchen
      • Tuebingen, Tyskland, 72076
        • Universitaetsklinik Tuebingen, Klinik fuer Psychiatrie und Psychotherapie
  • Ungarn
      • Budapest, Ungarn, 1137
        • Processus Kft., Varoskapu Rendelo
      • Budapest, Ungarn, 1135
        • Fovarosi Onkormanyzat Nyiro Gyula Korhaz, II. Pszichiatriai Osztaly
      • Gyula, Ungarn, 5700
        • Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza, Pszichiatriai Osztaly
      • Kunszentmarton, Ungarn, 5440
        • Varosi Egeszsegugyi Kozpont
      • Szekesfehervar, Ungarn, 8000
        • Fejer Megyei Szent Gyorgy Korhaz, Pszichiatriai Osztaly
      • Szentes, Ungarn, 6600
        • Donatella 99 Bt.

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 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Male or female cigarette smokers, 18-75 years, motivated to stop smoking and considered suitable for a smoking cessation attempt
  • Smoked an average of at least 10 cigarettes per day during past year and over past month, and exhaled carbon monoxide (CO) > 10 ppm at screening
  • Current or past diagnosis of MDD without psychotic features, either single or recurrent, using DSM IV TR based on clinical assessment and confirmed by SCID and at least one of the following:
  • On stable antidepressant treatment for MDD (stable dose for at least 2 months)
  • Major depressive episode, using DSM IV TR, in the past 2 years successfully treated

Exclusion Criteria:

  • Current or past diagnosis of dementia, schizophrenia, schizoaffective disorder, or other psychotic disorder, bipolar I disorder, bipolar II disorder.
  • Subjects with antisocial, schizotypal, or any other personality disorder severe enough to compromise the subject's ability to comply with the study requirements..
  • Current use of either bupropion or nortryptiline.

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: placebo
Medicin: placebo
placebo tablets matched in appearance and dosage to varenicline tablets
Eksperimentel: vareniclin
Medicin: varenicline
varenicline tablets titrated to 1 mg BID during 1st week and then 1 mg BID for 11 weeks
Andre navne:
  • Champix/Chantix

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With a Four-Week Continuous Quit Rate (CQR)
Tidsramme: Week 9 through Week 12
Percentage of participants who reported no use of nicotine-containing products by answering "No" to the nicotine use inventory (NUI) questions: 'Has the participant smoked cigarettes' and 'Has the participant used other nicotine-containing products' in the last 7 days (Week 9) or since last study visit (Week 9 through 12) confirmed by a measurement of an end-expiratory exhaled carbon monoxide (CO) measurement less than or equal to 10 parts per million (ppm).
Week 9 through Week 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Continuous Abstinence Rate (CAR)
Tidsramme: Week 9 through Week 24, Week 9 through Week 52
Percentage of participants who remained abstinent from the period defined as start of the primary endpoint (Week 9) through Week 24 and the end of follow-up (Week 52) by reporting no use of nicotine-containing products confirmed by a measurement of an end-expiratory exhaled CO measurement less than or equal to 10 ppm.
Week 9 through Week 24, Week 9 through Week 52
Number of Participants With 7-day Point Prevalence (PP) of Abstinence
Tidsramme: Weeks 12, 24, 52
Number of participants reporting no use of nicotine-containing products in the last 7 days confirmed by a measurement of an end-expiratory exhaled CO measurement less than or equal to 10 ppm.
Weeks 12, 24, 52
Number of Participants With 4-Week Point Prevalence (PP) of Abstinence
Tidsramme: Week 52
Number of participants at Week 52 visit reporting no smoking and no use of other tobacco products in the last 4 weeks confirmed by a measurement of an end-expiratory exhaled CO measurement less than or equal to 10 ppm.
Week 52

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Adverse Events (Including Solicited Neuropsychiatric Adverse Events)
Tidsramme: Baseline up to Week 16
Adverse Event (AE):any untoward medical occurrence attributed to study drug in participant who received study drug.SAE:AE causing:death;initial/prolonged inpatient hospitalization;life-threatening experience(immediate risk of dying);persistent/significant disability/incapacity;congenital anomaly.Solicited AEs collected by semi-structured neuropsychiatric AEs interview inquiring about AEs:delusions,hallucinations,paranoia,psychosis,mania,panic,agitation,hostility,aggression,homicidal ideation. If participant had positive response,investigator determined if it met AE criteria.
Baseline up to Week 16
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
Tidsramme: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16, 24, 32, 40, 52
CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement from baseline is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected
Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16, 24, 32, 40, 52
Number of Participants With Clinical Global Impression - Severity (CGI-S) Score
Tidsramme: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16, 24, 32, 40, 52
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected
Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16, 24, 32, 40, 52
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score
Tidsramme: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16
Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Change: mean score at observation minus mean score at baseline.
Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16
Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score
Tidsramme: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16
HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected. Change: mean score at observation minus mean score at baseline.
Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16
Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score
Tidsramme: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16
The BIS-11 is a self-administered 30 items questionnaire to assess measure of impulsivity. Items are scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). Total score range from 30 to 120. Barratt suggested that a total score of greater than or equal to 75 could indicate an impulse-control disorder, whereas a total score in the range of 70 to 75 could indicate pathological impulsivity.
Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Tidsramme: Baseline, Week 1 up to 30 days after Week 12 (treatment-emergent [TE]), thereafter up to Week 52 (follow-up [FU])
C-SSRS assessed if participant experienced following: completed suicide (1), suicide attempt (2)(response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3)("Yes" on "preparatory acts or behavior"), suicidal ideation (4)("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)("Yes" on "Has participant engaged in non-suicidal self-injurious behavior").
Baseline, Week 1 up to 30 days after Week 12 (treatment-emergent [TE]), thereafter up to Week 52 (follow-up [FU])

Samarbejdspartnere og efterforskere

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

Sponsor

Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

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. marts 2010

Primær færdiggørelse (Faktiske)

1. juni 2012

Studieafslutning (Faktiske)

1. juni 2012

Datoer for studieregistrering

Først indsendt

26. februar 2010

Først indsendt, der opfyldte QC-kriterier

26. februar 2010

Først opslået (Skøn)

2. marts 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. april 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. marts 2013

Sidst verificeret

1. marts 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A3051122

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 Depression

Kliniske forsøg med varenicline

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