Safety And Efficacy Of 12 Weeks Of Varenicline For Smoking Cessation In Smokers With Depression
6 maart 2013 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
525
Fase
- Fase 4
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Banja Luka, Bosnië-Herzegovina, 78000
- Psychiatric Clinic, Clinical Center Banja Luka
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Sarajevo, Bosnië-Herzegovina, 71000
- Clinic of Psychiatry, Clinical Center University of Sarajevo
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Freiburg, Duitsland, 79104
- Universitaetsklinikum Freiburg
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Muenchen, Duitsland, 80336
- Ludwig Maximilians-Universitaet Muenchen
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Tuebingen, Duitsland, 72076
- Universitaetsklinik Tuebingen, Klinik fuer Psychiatrie und Psychotherapie
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Budapest, Hongarije, 1137
- Processus Kft., Varoskapu Rendelo
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Budapest, Hongarije, 1135
- Fovarosi Onkormanyzat Nyiro Gyula Korhaz, II. Pszichiatriai Osztaly
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Gyula, Hongarije, 5700
- Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza, Pszichiatriai Osztaly
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Kunszentmarton, Hongarije, 5440
- Varosi Egeszsegugyi Kozpont
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Szekesfehervar, Hongarije, 8000
- Fejer Megyei Szent Gyorgy Korhaz, Pszichiatriai Osztaly
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Szentes, Hongarije, 6600
- Donatella 99 Bt.
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Zagreb, Kroatië, 10000
- "Poliklinika Neuron" - Croatian Institute for Brain Research
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Zagreb, Kroatië, 10000
- Psychiatric Hospital Vrapce
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Bucuresti, Roemenië, 041902
- Spitalul Clinic de Psihiatrie Prof. Dr. Al. Obregia, sectia 2
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Iasi, Roemenië, 700282
- Spitalul Clinic de Psihiatrie Socola, sectia VII
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Sector 4
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Bucuresti, Sector 4, Roemenië
- Spitalul Psihiatrie "Prof. Dr. Al. Obregia"
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Moscow, Russische Federatie, 107076
- Federal State Institution Moscow Scientific Research Institute of Psychiatry of Roszdrav
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Moscow, Russische Federatie, 115522
- Institution of Russian Academy of Medical Sciences Mental Health Research Center
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Moscow, Russische Federatie, 125367
- Moscow State Healthcare Institution Clinical Mental Hospital No 12
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St-Petersburg, Russische Federatie, 190121
- St-Petersburg State Healthcare Institution St. Nicholas Mental Hospital
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Barcelona, Spanje, 08025
- Hospital de La Santa Creu i Sant Pau
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Barcelona, Spanje, 08035
- Hospital General de La Vall D'Hebron
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Zaragoza, Spanje, 50007
- Centro de Salud Torrero La Paz
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Asturias
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Oviedo, Asturias, Spanje, 33011
- Centro de Salud Mental Ii "La Corredoria"
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California
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Garden Grove, California, Verenigde Staten, 92845
- Collaborative Neuroscience Network, Inc.
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Sherman Oaks, California, Verenigde Staten, 91403
- California Neuroscience Research Medical Group, Inc
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Colorado
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Aurora, Colorado, Verenigde Staten, 80045
- Behavioral Health and Wellness Program, University of Colorado Denver
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Connecticut
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Norwich, Connecticut, Verenigde Staten, 06360
- Comprehensive Psychiatric Care
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Florida
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Fort Walton Beach, Florida, Verenigde Staten, 32547
- Emerald Coast Mood & Memory, PA
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Jacksonville, Florida, Verenigde Staten, 32216
- Clinical Neuroscience Solutions Incorporated
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Orlando, Florida, Verenigde Staten, 32806
- Clinical Neuroscience Solutions Incorporated
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Kansas
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Overland, Kansas, Verenigde Staten, 66211
- Vince and Associates Clinical Research
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Overland Park, Kansas, Verenigde Staten, 66212
- Vince and Associates Clinical Research
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Wichita, Kansas, Verenigde Staten, 67207
- Heartland Research Associates, LLC
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Ohio
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Beachwood, Ohio, Verenigde Staten, 44122
- NorthCoast Clinical Trials Inc.
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Cincinnati, Ohio, Verenigde Staten, 45219
- University of Cincinnati
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Cincinnati, Ohio, Verenigde Staten, 45237
- University of Cincinnati
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19139
- CRI Worldwide LLC
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Tennessee
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Bartlett, Tennessee, Verenigde Staten, 38134
- Clinical Trials of Memphis
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Texas
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Austin, Texas, Verenigde Staten, 78731
- FutureSearch Trials
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Houston, Texas, Verenigde Staten, 77008
- Claghorn-Lesem Research Clinic, Ltd.
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 75 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Placebo-vergelijker: placebo
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placebo tablets matched in appearance and dosage to varenicline tablets
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Experimenteel: varenicline
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varenicline tablets titrated to 1 mg BID during 1st week and then 1 mg BID for 11 weeks
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Percentage of Participants With a Four-Week Continuous Quit Rate (CQR)
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Percentage of Participants With Continuous Abstinence Rate (CAR)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Number of Participants With Adverse Events (Including Solicited Neuropsychiatric Adverse Events)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 maart 2010
Primaire voltooiing (Werkelijk)
1 juni 2012
Studie voltooiing (Werkelijk)
1 juni 2012
Studieregistratiedata
Eerst ingediend
26 februari 2010
Eerst ingediend dat voldeed aan de QC-criteria
26 februari 2010
Eerst geplaatst (Schatting)
2 maart 2010
Updates van studierecords
Laatste update geplaatst (Schatting)
16 april 2013
Laatste update ingediend die voldeed aan QC-criteria
6 maart 2013
Laatst geverifieerd
1 maart 2013
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- A3051122
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .