Study Evaluating Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder
4 de marzo de 2011 actualizado por: Wyeth is now a wholly owned subsidiary of Pfizer
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study To Evaluate Functional Outcome In Outpatients With Major Depressive Disorder Treated With Desvenlafaxine Succinare Sustained Release
This is a multicenter study to assess the health and well-being in subjects who are outpatients with major depressive disorder that take desvenlafaxine succinate sustained release (DVS SR) or placebo for 12 weeks.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
437
Fase
- Fase 3
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
19 años a 74 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Outpatient men and women, between the ages of 18 to 75 years, fluent in both written and spoken English.
- Employed for 20 hours or more for a minimum of 1 month prior to baseline.
- Primary diagnosis of Major Depressive Disorder with symptoms for at least 30 days prior to baseline.
Exclusion Criteria:
- Treatment with desvenlafaxine succinate sustained release at any time in the past and/or venlafaxine (Effexor or Effexor XR) 1 year prior to baseline.
- Treatment-resistant defined as any of the following failed treatments in the past 3 years: 3 or more previous adequate trials of >=2 classes of antidepressant medication, electroconvulsive therapy, or psychotherapy (2 adequate trials).
- Current (within 12 months prior to the screening visit) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder.
- Clinically important abnormalities on physical examination, electrocardiogram (ECG), or laboratory evaluations.
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: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 2
|
CYP2D6 genotyping at randomization
|
|
Comparador de placebos: 1
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50 mg/day oral tablet for 12 weeks
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change From Baseline in Hamilton Depression Scale (HAM-D) at Week 12
Periodo de tiempo: At Baseline and Week 12.
|
HAM-D, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilt feelings, suicide, sleep disturbances, anxiety levels and weight loss).
Total score ranges from 0 to 52; higher scores indicate more depression.
Change from baseline: mean at observation minus mean at baseline.
|
At Baseline and Week 12.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 12
Periodo de tiempo: At Baseline and Week 12.
|
Participant rated scale was used to assess the effect of the participant's symptoms on their work/social/family life.
Total scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life.
Individual item scores range from 0 to 10.
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At Baseline and Week 12.
|
|
Clinical Global Impression Scale - Improvement (CGI- I) Score at Week 12
Periodo de tiempo: At Baseline and Week 12.
|
CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse).
Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.
Higher score = more affected.
Change = score at observation minus score at baseline.
|
At Baseline and Week 12.
|
|
Clinical Global Impressions Scale - Severity of Illness (CGI-S) at Week 12
Periodo de tiempo: At Baseline and Week 12.
|
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.
Change: score at observation minus score at baseline.
|
At Baseline and Week 12.
|
|
Change From Baseline on Work and Activities Item of HAM-D17 at Week 12
Periodo de tiempo: At Baseline and Week 12.
|
The Work and Activities Item of the HAM-D17 is item 7 of HAM-D17.
Scoring range from 0 to 4.
|
At Baseline and Week 12.
|
|
Change From Baseline in Adjusted Mean on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 12
Periodo de tiempo: At Baseline and Week 12.
|
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).
|
At Baseline and Week 12.
|
|
Change From Baseline on Worry Anxiety Tension Scale (WATS) at Week 12
Periodo de tiempo: At Baseline and Week 12.
|
WATS: a self-administered, 3-question rating scale assesses worry, anxiety, and tension.
Each item was a visual analog scale on which the participant circles a number from 0 to 10. Higher scores indicated worse function.
WATS total score was the sum of the 3 items.
If 1 item was missing, the total score would be missing.
|
At Baseline and Week 12.
|
|
Change From Baseline on Stress and Social Support Scales at Week 12
Periodo de tiempo: At Baseline and Week 12.
|
Stress and Social Support Scales: self-administered rating scale where item 1 is the stress vulnerability scale measuring how much the subject was set back by stressful events on an 11-point scale ranging from 0 (not at all) to 10 (extremely) and item 2 is an 11-point scale ranging from 0 to 100 percent of the amount of support the subject received from relatives and friends.
|
At Baseline and Week 12.
|
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.
Publicaciones Generales
- Zilcha-Mano S, Wang X, Wajsbrot DB, Boucher M, Fine SA, Rutherford BR. Trajectories of Function and Symptom Change in Desvenlafaxine Clinical Trials: Toward Personalized Treatment for Depression. J Clin Psychopharmacol. 2021 Sep-Oct 01;41(5):579-584. doi: 10.1097/JCP.0000000000001435.
- Soares CN, Zhang M, Boucher M. Categorical improvement in functional impairment in depressed patients treated with desvenlafaxine. CNS Spectr. 2019 Jun;24(3):322-332. doi: 10.1017/S1092852917000633. Epub 2017 Nov 15.
- Reddy S, Fayyad R, Edgar CJ, Guico-Pabia CJ, Wesnes K. The effect of desvenlafaxine on cognitive functioning in employed outpatients with major depressive disorder: a substudy of a randomized, double-blind, placebo-controlled trial. J Psychopharmacol. 2016 Jun;30(6):559-67. doi: 10.1177/0269881116631649. Epub 2016 Mar 23.
- McIntyre RS, Fayyad R, Mackell JA, Boucher M. Effect of metabolic syndrome and thyroid hormone on efficacy of desvenlafaxine 50 and 100 mg/d in major depressive disorder. Curr Med Res Opin. 2016;32(3):587-99. doi: 10.1185/03007995.2015.1136603. Epub 2016 Jan 13.
- McIntyre RS, Fayyad RS, Guico-Pabia CJ, Boucher M. A Post Hoc Analysis of the Effect of Weight on Efficacy in Depressed Patients Treated With Desvenlafaxine 50 mg/d and 100 mg/d. Prim Care Companion CNS Disord. 2015 Jun 4;17(3):10.4088/PCC.14m01741. doi: 10.4088/PCC.14m01741. eCollection 2015.
- Thase ME, Fayyad R, Cheng RF, Guico-Pabia CJ, Sporn J, Boucher M, Tourian KA. Effects of desvenlafaxine on blood pressure in patients treated for major depressive disorder: a pooled analysis. Curr Med Res Opin. 2015 Apr;31(4):809-20. doi: 10.1185/03007995.2015.1020365. Epub 2015 Mar 26.
- Endicott J, Lam RW, Hsu MA, Fayyad R, Boucher M, Guico-Pabia CJ. Improvements in quality of life with desvenlafaxine 50mg/d vs placebo in employed adults with major depressive disorder. J Affect Disord. 2014 Sep;166:307-14. doi: 10.1016/j.jad.2014.05.011. Epub 2014 May 21.
- Lam RW, Endicott J, Hsu MA, Fayyad R, Guico-Pabia C, Boucher M. Predictors of functional improvement in employed adults with major depressive disorder treated with desvenlafaxine. Int Clin Psychopharmacol. 2014 Sep;29(5):239-51. doi: 10.1097/YIC.0000000000000031.
- Soares CN, Endicott J, Boucher M, Fayyad RS, Guico-Pabia CJ. Predictors of functional response and remission with desvenlafaxine 50 mg/d in patients with major depressive disorder. CNS Spectr. 2014 Dec;19(6):519-27. doi: 10.1017/S1092852914000066. Epub 2014 Feb 26.
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 febrero de 2009
Finalización primaria (Actual)
1 de octubre de 2009
Finalización del estudio (Actual)
1 de noviembre de 2009
Fechas de registro del estudio
Enviado por primera vez
14 de enero de 2009
Primero enviado que cumplió con los criterios de control de calidad
15 de enero de 2009
Publicado por primera vez (Estimar)
16 de enero de 2009
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
10 de marzo de 2011
Última actualización enviada que cumplió con los criterios de control de calidad
4 de marzo de 2011
Última verificación
1 de marzo de 2011
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Síntomas de comportamiento
- Desordenes mentales
- Procesos Patológicos
- Trastornos del estado de ánimo
- Depresión
- Desorden depresivo
- Enfermedad
- Trastorno Depresivo Mayor
- Efectos fisiológicos de las drogas
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Drogas psicotropicas
- Inhibidores de la captación de neurotransmisores
- Moduladores de transporte de membrana
- Agentes antidepresivos
- Inhibidores de la recaptación de serotonina y noradrenalina
- Succinato de desvenlafaxina
Otros números de identificación del estudio
- 3151A1-4415
- B2061006
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. .