Safety And Efficacy Of 12 Weeks Of Varenicline For Smoking Cessation In Smokers With Depression
6 de marzo de 2013 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
525
Fase
- Fase 4
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Freiburg, Alemania, 79104
- Universitaetsklinikum Freiburg
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Muenchen, Alemania, 80336
- Ludwig Maximilians-Universitaet Muenchen
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Tuebingen, Alemania, 72076
- Universitaetsklinik Tuebingen, Klinik fuer Psychiatrie und Psychotherapie
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Banja Luka, Bosnia y Herzegovina, 78000
- Psychiatric Clinic, Clinical Center Banja Luka
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Sarajevo, Bosnia y Herzegovina, 71000
- Clinic of Psychiatry, Clinical Center University of Sarajevo
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Zagreb, Croacia, 10000
- "Poliklinika Neuron" - Croatian Institute for Brain Research
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Zagreb, Croacia, 10000
- Psychiatric Hospital Vrapce
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Barcelona, España, 08025
- Hospital de La Santa Creu i Sant Pau
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Barcelona, España, 08035
- Hospital General de La Vall D'Hebron
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Zaragoza, España, 50007
- Centro de Salud Torrero La Paz
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Asturias
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Oviedo, Asturias, España, 33011
- Centro de Salud Mental Ii "La Corredoria"
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California
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Garden Grove, California, Estados Unidos, 92845
- Collaborative Neuroscience Network, Inc.
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Sherman Oaks, California, Estados Unidos, 91403
- California Neuroscience Research Medical Group, Inc
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- Behavioral Health and Wellness Program, University of Colorado Denver
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Connecticut
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Norwich, Connecticut, Estados Unidos, 06360
- Comprehensive Psychiatric Care
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Florida
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Fort Walton Beach, Florida, Estados Unidos, 32547
- Emerald Coast Mood & Memory, PA
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Jacksonville, Florida, Estados Unidos, 32216
- Clinical Neuroscience Solutions Incorporated
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Orlando, Florida, Estados Unidos, 32806
- Clinical Neuroscience Solutions Incorporated
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Kansas
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Overland, Kansas, Estados Unidos, 66211
- Vince and Associates Clinical Research
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Overland Park, Kansas, Estados Unidos, 66212
- Vince and Associates Clinical Research
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Wichita, Kansas, Estados Unidos, 67207
- Heartland Research Associates, LLC
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Ohio
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Beachwood, Ohio, Estados Unidos, 44122
- NorthCoast Clinical Trials Inc.
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Cincinnati, Ohio, Estados Unidos, 45219
- University of Cincinnati
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Cincinnati, Ohio, Estados Unidos, 45237
- University of Cincinnati
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19139
- CRI Worldwide LLC
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Tennessee
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Bartlett, Tennessee, Estados Unidos, 38134
- Clinical Trials of Memphis
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Texas
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Austin, Texas, Estados Unidos, 78731
- FutureSearch Trials
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Houston, Texas, Estados Unidos, 77008
- Claghorn-Lesem Research Clinic, Ltd.
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Moscow, Federación Rusa, 107076
- Federal State Institution Moscow Scientific Research Institute of Psychiatry of Roszdrav
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Moscow, Federación Rusa, 115522
- Institution of Russian Academy of Medical Sciences Mental Health Research Center
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Moscow, Federación Rusa, 125367
- Moscow State Healthcare Institution Clinical Mental Hospital No 12
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St-Petersburg, Federación Rusa, 190121
- St-Petersburg State Healthcare Institution St. Nicholas Mental Hospital
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Budapest, Hungría, 1137
- Processus Kft., Varoskapu Rendelo
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Budapest, Hungría, 1135
- Fovarosi Onkormanyzat Nyiro Gyula Korhaz, II. Pszichiatriai Osztaly
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Gyula, Hungría, 5700
- Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza, Pszichiatriai Osztaly
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Kunszentmarton, Hungría, 5440
- Varosi Egeszsegugyi Kozpont
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Szekesfehervar, Hungría, 8000
- Fejer Megyei Szent Gyorgy Korhaz, Pszichiatriai Osztaly
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Szentes, Hungría, 6600
- Donatella 99 Bt.
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Bucuresti, Rumania, 041902
- Spitalul Clinic de Psihiatrie Prof. Dr. Al. Obregia, sectia 2
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Iasi, Rumania, 700282
- Spitalul Clinic de Psihiatrie Socola, sectia VII
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Sector 4
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Bucuresti, Sector 4, Rumania
- Spitalul Psihiatrie "Prof. Dr. Al. Obregia"
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador de placebos: placebo
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placebo tablets matched in appearance and dosage to varenicline tablets
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Experimental: vareniclina
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varenicline tablets titrated to 1 mg BID during 1st week and then 1 mg BID for 11 weeks
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Percentage of Participants With a Four-Week Continuous Quit Rate (CQR)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Percentage of Participants With Continuous Abstinence Rate (CAR)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Participants With Adverse Events (Including Solicited Neuropsychiatric Adverse Events)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de marzo de 2010
Finalización primaria (Actual)
1 de junio de 2012
Finalización del estudio (Actual)
1 de junio de 2012
Fechas de registro del estudio
Enviado por primera vez
26 de febrero de 2010
Primero enviado que cumplió con los criterios de control de calidad
26 de febrero de 2010
Publicado por primera vez (Estimar)
2 de marzo de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
16 de abril de 2013
Última actualización enviada que cumplió con los criterios de control de calidad
6 de marzo de 2013
Última verificación
1 de marzo de 2013
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- A3051122
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .