Safety And Efficacy Of 12 Weeks Of Varenicline For Smoking Cessation In Smokers With Depression
6. mars 2013 oppdatert 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
525
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Banja Luka, Bosnia og Herzegovina, 78000
- Psychiatric Clinic, Clinical Center Banja Luka
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Sarajevo, Bosnia og Herzegovina, 71000
- Clinic of Psychiatry, Clinical Center University of Sarajevo
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Moscow, Den russiske føderasjonen, 107076
- Federal State Institution Moscow Scientific Research Institute of Psychiatry of Roszdrav
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Moscow, Den russiske føderasjonen, 115522
- Institution of Russian Academy of Medical Sciences Mental Health Research Center
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Moscow, Den russiske føderasjonen, 125367
- Moscow State Healthcare Institution Clinical Mental Hospital No 12
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St-Petersburg, Den russiske føderasjonen, 190121
- St-Petersburg State Healthcare Institution St. Nicholas Mental Hospital
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California
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Garden Grove, California, Forente stater, 92845
- Collaborative Neuroscience Network, Inc.
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Sherman Oaks, California, Forente stater, 91403
- California Neuroscience Research Medical Group, Inc
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Colorado
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Aurora, Colorado, Forente stater, 80045
- Behavioral Health and Wellness Program, University of Colorado Denver
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Connecticut
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Norwich, Connecticut, Forente stater, 06360
- Comprehensive Psychiatric Care
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Florida
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Fort Walton Beach, Florida, Forente stater, 32547
- Emerald Coast Mood & Memory, PA
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Jacksonville, Florida, Forente stater, 32216
- Clinical Neuroscience Solutions Incorporated
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Orlando, Florida, Forente stater, 32806
- Clinical Neuroscience Solutions Incorporated
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Kansas
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Overland, Kansas, Forente stater, 66211
- Vince and Associates Clinical Research
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Overland Park, Kansas, Forente stater, 66212
- Vince and Associates Clinical Research
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Wichita, Kansas, Forente stater, 67207
- Heartland Research Associates, LLC
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Ohio
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Beachwood, Ohio, Forente stater, 44122
- NorthCoast Clinical Trials Inc.
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Cincinnati, Ohio, Forente stater, 45219
- University of Cincinnati
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Cincinnati, Ohio, Forente stater, 45237
- University of Cincinnati
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19139
- CRI Worldwide LLC
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Tennessee
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Bartlett, Tennessee, Forente stater, 38134
- Clinical Trials of Memphis
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Texas
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Austin, Texas, Forente stater, 78731
- FutureSearch Trials
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Houston, Texas, Forente stater, 77008
- Claghorn-Lesem Research Clinic, Ltd.
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Zagreb, Kroatia, 10000
- "Poliklinika Neuron" - Croatian Institute for Brain Research
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Zagreb, Kroatia, 10000
- Psychiatric Hospital Vrapce
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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, Spania, 08025
- Hospital de La Santa Creu i Sant Pau
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Barcelona, Spania, 08035
- Hospital General de La Vall D'Hebron
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Zaragoza, Spania, 50007
- Centro de Salud Torrero La Paz
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Asturias
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Oviedo, Asturias, Spania, 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, Ungarn, 1137
- Processus Kft., Varoskapu Rendelo
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Budapest, Ungarn, 1135
- Fovarosi Onkormanyzat Nyiro Gyula Korhaz, II. Pszichiatriai Osztaly
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Gyula, Ungarn, 5700
- Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza, Pszichiatriai Osztaly
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Kunszentmarton, Ungarn, 5440
- Varosi Egeszsegugyi Kozpont
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Szekesfehervar, Ungarn, 8000
- Fejer Megyei Szent Gyorgy Korhaz, Pszichiatriai Osztaly
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Szentes, Ungarn, 6600
- Donatella 99 Bt.
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Placebo komparator: placebo
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placebo tablets matched in appearance and dosage to varenicline tablets
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Eksperimentell: vareniklin
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varenicline tablets titrated to 1 mg BID during 1st week and then 1 mg BID for 11 weeks
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Percentage of Participants With a Four-Week Continuous Quit Rate (CQR)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Participants With Continuous Abstinence Rate (CAR)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Number of Participants With Adverse Events (Including Solicited Neuropsychiatric Adverse Events)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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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Samarbeidspartnere og etterforskere
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Sponsor
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Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mars 2010
Primær fullføring (Faktiske)
1. juni 2012
Studiet fullført (Faktiske)
1. juni 2012
Datoer for studieregistrering
Først innsendt
26. februar 2010
Først innsendt som oppfylte QC-kriteriene
26. februar 2010
Først lagt ut (Anslag)
2. mars 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
16. april 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. mars 2013
Sist bekreftet
1. mars 2013
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- A3051122
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .