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

6 mars 2013 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

525

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 75 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur placebo: placebo
Médicament: placebo
placebo tablets matched in appearance and dosage to varenicline tablets
Expérimental: varénicline
Médicament: varenicline
varenicline tablets titrated to 1 mg BID during 1st week and then 1 mg BID for 11 weeks
Autres noms:
  • Champix/Chantix

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percentage of Participants With a Four-Week Continuous Quit Rate (CQR)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Percentage of Participants With Continuous Abstinence Rate (CAR)
Délai: 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
Délai: 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
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Number of Participants With Adverse Events (Including Solicited Neuropsychiatric Adverse Events)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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])

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Pfizer

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mars 2010

Achèvement primaire (Réel)

1 juin 2012

Achèvement de l'étude (Réel)

1 juin 2012

Dates d'inscription aux études

Première soumission

26 février 2010

Première soumission répondant aux critères de contrôle qualité

26 février 2010

Première publication (Estimation)

2 mars 2010

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

16 avril 2013

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 mars 2013

Dernière vérification

1 mars 2013

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • A3051122

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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