Safety And Efficacy Of 12 Weeks Of Varenicline For Smoking Cessation In Smokers With Depression
6 mars 2013 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
525
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Banja Luka, Bosnien och Hercegovina, 78000
- Psychiatric Clinic, Clinical Center Banja Luka
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Sarajevo, Bosnien och Hercegovina, 71000
- Clinic of Psychiatry, Clinical Center University of Sarajevo
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California
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Garden Grove, California, Förenta staterna, 92845
- Collaborative Neuroscience Network, Inc.
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Sherman Oaks, California, Förenta staterna, 91403
- California Neuroscience Research Medical Group, Inc
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Colorado
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Aurora, Colorado, Förenta staterna, 80045
- Behavioral Health and Wellness Program, University of Colorado Denver
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Connecticut
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Norwich, Connecticut, Förenta staterna, 06360
- Comprehensive Psychiatric Care
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Florida
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Fort Walton Beach, Florida, Förenta staterna, 32547
- Emerald Coast Mood & Memory, PA
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Jacksonville, Florida, Förenta staterna, 32216
- Clinical Neuroscience Solutions Incorporated
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Orlando, Florida, Förenta staterna, 32806
- Clinical Neuroscience Solutions Incorporated
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Kansas
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Overland, Kansas, Förenta staterna, 66211
- Vince and Associates Clinical Research
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Overland Park, Kansas, Förenta staterna, 66212
- Vince and Associates Clinical Research
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Wichita, Kansas, Förenta staterna, 67207
- Heartland Research Associates, LLC
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Ohio
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Beachwood, Ohio, Förenta staterna, 44122
- NorthCoast Clinical Trials Inc.
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Cincinnati, Ohio, Förenta staterna, 45219
- University of Cincinnati
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Cincinnati, Ohio, Förenta staterna, 45237
- University of Cincinnati
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19139
- CRI Worldwide LLC
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Tennessee
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Bartlett, Tennessee, Förenta staterna, 38134
- Clinical Trials of Memphis
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Texas
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Austin, Texas, Förenta staterna, 78731
- FutureSearch Trials
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Houston, Texas, Förenta staterna, 77008
- Claghorn-Lesem Research Clinic, Ltd.
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Zagreb, Kroatien, 10000
- "Poliklinika Neuron" - Croatian Institute for Brain Research
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Zagreb, Kroatien, 10000
- Psychiatric Hospital Vrapce
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Bucuresti, Rumänien, 041902
- Spitalul Clinic de Psihiatrie Prof. Dr. Al. Obregia, sectia 2
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Iasi, Rumänien, 700282
- Spitalul Clinic de Psihiatrie Socola, sectia VII
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Sector 4
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Bucuresti, Sector 4, Rumänien
- Spitalul Psihiatrie "Prof. Dr. Al. Obregia"
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Moscow, Ryska Federationen, 107076
- Federal State Institution Moscow Scientific Research Institute of Psychiatry of Roszdrav
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Moscow, Ryska Federationen, 115522
- Institution of Russian Academy of Medical Sciences Mental Health Research Center
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Moscow, Ryska Federationen, 125367
- Moscow State Healthcare Institution Clinical Mental Hospital No 12
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St-Petersburg, Ryska Federationen, 190121
- St-Petersburg State Healthcare Institution St. Nicholas Mental Hospital
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Barcelona, Spanien, 08025
- Hospital de La Santa Creu i Sant Pau
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Barcelona, Spanien, 08035
- Hospital General de La Vall D'Hebron
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Zaragoza, Spanien, 50007
- Centro de Salud Torrero La Paz
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Asturias
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Oviedo, Asturias, Spanien, 33011
- Centro de Salud Mental Ii "La Corredoria"
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Freiburg, Tyskland, 79104
- Universitaetsklinikum Freiburg
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Muenchen, Tyskland, 80336
- Ludwig Maximilians-Universitaet Muenchen
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Tuebingen, Tyskland, 72076
- Universitaetsklinik Tuebingen, Klinik fuer Psychiatrie und Psychotherapie
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Budapest, Ungern, 1137
- Processus Kft., Varoskapu Rendelo
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Budapest, Ungern, 1135
- Fovarosi Onkormanyzat Nyiro Gyula Korhaz, II. Pszichiatriai Osztaly
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Gyula, Ungern, 5700
- Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza, Pszichiatriai Osztaly
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Kunszentmarton, Ungern, 5440
- Varosi Egeszsegugyi Kozpont
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Szekesfehervar, Ungern, 8000
- Fejer Megyei Szent Gyorgy Korhaz, Pszichiatriai Osztaly
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Szentes, Ungern, 6600
- Donatella 99 Bt.
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Placebo-jämförare: placebo
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placebo tablets matched in appearance and dosage to varenicline tablets
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Experimentell: vareniklin
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varenicline tablets titrated to 1 mg BID during 1st week and then 1 mg BID for 11 weeks
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Percentage of Participants With a Four-Week Continuous Quit Rate (CQR)
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Percentage of Participants With Continuous Abstinence Rate (CAR)
Tidsram: 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
Tidsram: 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
Tidsram: 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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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Number of Participants With Adverse Events (Including Solicited Neuropsychiatric Adverse Events)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2010
Primärt slutförande (Faktisk)
1 juni 2012
Avslutad studie (Faktisk)
1 juni 2012
Studieregistreringsdatum
Först inskickad
26 februari 2010
Först inskickad som uppfyllde QC-kriterierna
26 februari 2010
Första postat (Uppskatta)
2 mars 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
16 april 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 mars 2013
Senast verifierad
1 mars 2013
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- A3051122
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .