Safety And Efficacy Of 12 Weeks Of Varenicline For Smoking Cessation In Smokers With Depression
6 marzo 2013 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
525
Fase
- Fase 4
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Banja Luka, Bosnia Erzegovina, 78000
- Psychiatric Clinic, Clinical Center Banja Luka
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Sarajevo, Bosnia Erzegovina, 71000
- Clinic of Psychiatry, Clinical Center University of Sarajevo
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Zagreb, Croazia, 10000
- "Poliklinika Neuron" - Croatian Institute for Brain Research
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Zagreb, Croazia, 10000
- Psychiatric Hospital Vrapce
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Moscow, Federazione Russa, 107076
- Federal State Institution Moscow Scientific Research Institute of Psychiatry of Roszdrav
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Moscow, Federazione Russa, 115522
- Institution of Russian Academy of Medical Sciences Mental Health Research Center
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Moscow, Federazione Russa, 125367
- Moscow State Healthcare Institution Clinical Mental Hospital No 12
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St-Petersburg, Federazione Russa, 190121
- St-Petersburg State Healthcare Institution St. Nicholas Mental Hospital
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Freiburg, Germania, 79104
- Universitaetsklinikum Freiburg
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Muenchen, Germania, 80336
- Ludwig Maximilians-Universitaet Muenchen
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Tuebingen, Germania, 72076
- Universitaetsklinik Tuebingen, Klinik fuer Psychiatrie und Psychotherapie
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Bucuresti, Romania, 041902
- Spitalul Clinic de Psihiatrie Prof. Dr. Al. Obregia, sectia 2
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Iasi, Romania, 700282
- Spitalul Clinic de Psihiatrie Socola, sectia VII
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Sector 4
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Bucuresti, Sector 4, Romania
- Spitalul Psihiatrie "Prof. Dr. Al. Obregia"
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Barcelona, Spagna, 08025
- Hospital de la Santa Creu i Sant Pau
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Barcelona, Spagna, 08035
- Hospital General de La Vall D'Hebron
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Zaragoza, Spagna, 50007
- Centro de Salud Torrero La Paz
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Asturias
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Oviedo, Asturias, Spagna, 33011
- Centro de Salud Mental Ii "La Corredoria"
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California
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Garden Grove, California, Stati Uniti, 92845
- Collaborative Neuroscience Network, Inc.
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Sherman Oaks, California, Stati Uniti, 91403
- California Neuroscience Research Medical Group, Inc
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Colorado
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Aurora, Colorado, Stati Uniti, 80045
- Behavioral Health and Wellness Program, University of Colorado Denver
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Connecticut
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Norwich, Connecticut, Stati Uniti, 06360
- Comprehensive Psychiatric Care
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Florida
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Fort Walton Beach, Florida, Stati Uniti, 32547
- Emerald Coast Mood & Memory, PA
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Jacksonville, Florida, Stati Uniti, 32216
- Clinical Neuroscience Solutions Incorporated
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Orlando, Florida, Stati Uniti, 32806
- Clinical Neuroscience Solutions Incorporated
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Kansas
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Overland, Kansas, Stati Uniti, 66211
- Vince and Associates Clinical Research
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Overland Park, Kansas, Stati Uniti, 66212
- Vince and Associates Clinical Research
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Wichita, Kansas, Stati Uniti, 67207
- Heartland Research Associates, LLC
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Ohio
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Beachwood, Ohio, Stati Uniti, 44122
- NorthCoast Clinical Trials Inc.
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Cincinnati, Ohio, Stati Uniti, 45219
- University of Cincinnati
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Cincinnati, Ohio, Stati Uniti, 45237
- University of Cincinnati
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19139
- CRI Worldwide LLC
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Tennessee
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Bartlett, Tennessee, Stati Uniti, 38134
- Clinical Trials of Memphis
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Texas
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Austin, Texas, Stati Uniti, 78731
- FutureSearch Trials
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Houston, Texas, Stati Uniti, 77008
- Claghorn-Lesem Research Clinic, Ltd.
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Budapest, Ungheria, 1137
- Processus Kft., Varoskapu Rendelo
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Budapest, Ungheria, 1135
- Fovarosi Onkormanyzat Nyiro Gyula Korhaz, II. Pszichiatriai Osztaly
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Gyula, Ungheria, 5700
- Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza, Pszichiatriai Osztaly
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Kunszentmarton, Ungheria, 5440
- Varosi Egeszsegugyi Kozpont
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Szekesfehervar, Ungheria, 8000
- Fejer Megyei Szent Gyorgy Korhaz, Pszichiatriai Osztaly
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Szentes, Ungheria, 6600
- Donatella 99 Bt.
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 75 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore placebo: placebo
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placebo tablets matched in appearance and dosage to varenicline tablets
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Sperimentale: vareniclina
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varenicline tablets titrated to 1 mg BID during 1st week and then 1 mg BID for 11 weeks
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Percentage of Participants With a Four-Week Continuous Quit Rate (CQR)
Lasso di tempo: Week 9 through Week 12
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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).
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Week 9 through Week 12
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percentage of Participants With Continuous Abstinence Rate (CAR)
Lasso di tempo: Week 9 through Week 24, Week 9 through Week 52
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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.
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Week 9 through Week 24, Week 9 through Week 52
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Number of Participants With 7-day Point Prevalence (PP) of Abstinence
Lasso di tempo: Weeks 12, 24, 52
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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.
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Weeks 12, 24, 52
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Number of Participants With 4-Week Point Prevalence (PP) of Abstinence
Lasso di tempo: Week 52
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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.
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Week 52
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Number of Participants With Adverse Events (Including Solicited Neuropsychiatric Adverse Events)
Lasso di tempo: Baseline up to Week 16
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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.
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Baseline up to Week 16
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Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
Lasso di tempo: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16, 24, 32, 40, 52
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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
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Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16, 24, 32, 40, 52
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Number of Participants With Clinical Global Impression - Severity (CGI-S) Score
Lasso di tempo: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16, 24, 32, 40, 52
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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
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Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16, 24, 32, 40, 52
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Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score
Lasso di tempo: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16
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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.
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Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16
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Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score
Lasso di tempo: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16
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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.
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Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16
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Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score
Lasso di tempo: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16
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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.
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Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16
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Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Lasso di tempo: Baseline, Week 1 up to 30 days after Week 12 (treatment-emergent [TE]), thereafter up to Week 52 (follow-up [FU])
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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").
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Baseline, Week 1 up to 30 days after Week 12 (treatment-emergent [TE]), thereafter up to Week 52 (follow-up [FU])
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 marzo 2010
Completamento primario (Effettivo)
1 giugno 2012
Completamento dello studio (Effettivo)
1 giugno 2012
Date di iscrizione allo studio
Primo inviato
26 febbraio 2010
Primo inviato che soddisfa i criteri di controllo qualità
26 febbraio 2010
Primo Inserito (Stima)
2 marzo 2010
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
16 aprile 2013
Ultimo aggiornamento inviato che soddisfa i criteri QC
6 marzo 2013
Ultimo verificato
1 marzo 2013
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- A3051122
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .