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Study of Antidepressants in Parkinson's Disease (SAD-PD)

3 de enero de 2013 actualizado por: Irene Richard, University of Rochester
The purpose of this study is to find out if two antidepressant medications, paroxetine and venlafaxine, can help control depression in Parkinson's disease, and if these medications affect the motor symptoms of Parkinson's disease such as tremor, stiffness, slowness, and balance.

Descripción general del estudio

Descripción detallada

Nearly 50 percent of individuals with Parkinson's disease (PD) suffer from depression-a condition that causes disability and can reduce quality of life. The University of Rochester Medical Center is conducting a research study of antidepressant medications to find out more about how to treat depression in PD. Antidepressant medications have not been adequately studied in persons with PD.

The purpose of this study is to find out if the antidepressant medications paroxetine and venlafaxine can help control depression in PD and whether or not these medications affect the motor symptoms of PD such as tremor, stiffness, slowness, and balance.

This is a randomized, double blind, placebo-controlled, 12-week study of paroxetine immediate release (Paxil) and venlafaxine extended release (Effexor XR). Paroxetine and venlafaxine XR are drugs that have been approved by the Food and Drug Administration (FDA) and are available by prescription. Paroxetine and venlafaxine XR have been shown to be effective in treating depression in the general population. Two hundred, twenty-eight persons will be enrolled among 15 medical centers throughout the United States and Canada. Each person will participate in the trial for 12 weeks. Each participant will be randomly assigned to take either paroxetine or venlafaxine, or a placebo.

Tipo de estudio

Intervencionista

Inscripción (Actual)

115

Fase

  • Fase 3

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

    • Ontario
      • London, Ontario, Canadá, N6A 5A5
        • London Health Sciences Centre, University Campus Room A10-325, 339 Windermere Road
    • Quebec
      • Montreal, Quebec, Canadá, H2W 1T8
        • Hotel-Dieu Hospital-CHUM
    • California
      • San Francisco, California, Estados Unidos, 94143
        • University of California San Francisco
    • Florida
      • Gainesville, Florida, Estados Unidos, 32610
        • University of Florida
      • Miami, Florida, Estados Unidos, 33136
        • University of Miami
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30322
        • Emory University School of Medicine
    • Kentucky
      • Lexington, Kentucky, Estados Unidos, 40536
        • University of Kentucky
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21218
        • Johns Hopkins University
      • Baltimore, Maryland, Estados Unidos, 21250
        • University of Maryland
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02215
        • Beth Israel Deaconess Medical Center, Dept. of Neurology E/KS 430, 330 Brookline Avenue
    • Missouri
      • St. Louis, Missouri, Estados Unidos, 63110
        • Washington University School of Medicine
    • New York
      • Rochester, New York, Estados Unidos, 14627
        • University of Rochester
    • Ohio
      • Toledo, Ohio, Estados Unidos
        • Medical University of Ohio
    • Oregon
      • Portland, Oregon, Estados Unidos, 97239
        • Oregon Health Sciences University
    • Tennessee
      • Memphis, Tennessee, Estados Unidos, 38163
        • University of Tennessee-Memphis
    • Texas
      • Houston, Texas, Estados Unidos, 77030
        • Baylor College of Medicine, 6550 Fannin, Suite 1801
    • Virginia
      • Charlottesville, Virginia, Estados Unidos, 22901
        • University of Virginia
      • San Juan, Puerto Rico, 00936
        • University of Puerto Rico

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

30 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

To be eligible you must be:

  • 30 years old or older
  • diagnosed with Parkinson's disease
  • experiencing symptoms of depression such as sadness, decreased energy, or problems sleeping

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
Comparador activo: paroxetine
Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
Paroxetine 10 mg tablets or matching placebo given once a day for the first two weeks. If depression is not being effectively treated then the paroxetine or matching placebo will be increased to 20 mg, followed by a 10 mg increase every two weeks (if tolerated). Dosage for this study will not exceed 40 mg.
Otros nombres:
  • Paxil
Comparador activo: venlafaxine extended release
Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
Venlafaxine XR 37.5 mg capsules or matching placebo given once a day for the first two weeks. If depression is not being effectively treated then the venlafaxine XR capsules or matching placebo will be increased to 75 mg followed by 75 mg increments every 2 weeks (if tolerated). Dosage for this study will not exceed 225 mg.
Otros nombres:
  • Effexor XR
Comparador de placebos: placebo
Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
una sustancia inactiva

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Hamilton Depression Rating Scale (HAM-D) Scores
Periodo de tiempo: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Hamilton Rating Scale for Depression over 12 weeks. Hamilton Depression Rating Scale ranges from 0-50. Higher scores represent more significant depression. Mild depression ranges from 8-13, moderate depression from 14-18, severe 19-22 and very severe any score over 23.
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
Periodo de tiempo: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Montgomery-Asberg Depression Rating Scale ranges from 0-60. Higher score indicates more severe depression. 0-6 normal, 7-19 mild depression, 20-34 moderate depression, greater than 34 severe depression.
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Beck Depression Inventory II (BDI-II)
Periodo de tiempo: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Beck Depression Inventory II ranges from 0-63. Higher score indicates more severe depression. 0-13 minimal depression, 14-19 mild depression, 20-28 moderate depression, 29-63 severe depression.
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Geriatric Depression Rating Scale (GDS)
Periodo de tiempo: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Geriatric Depression Scale ranges from 0-30. Higher score indicates more severe depression. 0-9 normal, 10-19 mild depression, 20-30 severe depression.
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Brief Psychiatric Rating Scale (BPRS)
Periodo de tiempo: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Brief Psychiatric Rating Scale. Maximum score 126. Higher score indicates greater psychiatric difficulties.
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Unified Parkinson's Disease Rating Scale (UPDRS)
Periodo de tiempo: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Unified Parkinson's Disease Rating Scale. Higher score indicates more severe Parkinson's disease symptoms. Total maximum = 176. Mental maximum = 52, Activities of Daily Living maximum = 52, Motor maximum = 72. Minimum = 0.
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Snaith Clinical Anxiety Scale (CAS)
Periodo de tiempo: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Snaith Clinical Anxiety Scale. Range 0-21. Higher scores indicate increased anxiety. Score greater than 8 indicates clinical anxiety.
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Pittsburgh Sleep Quality Index (PSQI)
Periodo de tiempo: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Pittsburgh Sleep Quality Index scores range from 0-21, with higher scores indicating severe sleep difficulties.
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Motor
Periodo de tiempo: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Unified Parkinson's Disease Rating Scale - Motor has a maximum score of 72, minimum score of 0. Higher score indicates more severe Parkinson's disease symptoms.
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Tremor
Periodo de tiempo: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Unified Parkinson's Disease Rating Scale - Tremor subscale ranges from 0-23. Higher score indicates more severe Parkinson's disease symptoms.
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Bulbar
Periodo de tiempo: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Unified Parkinson's Disease Rating Scale - Bulbar maximum score 24, minimum score of 0. Higher score indicates more severe Parkinson's disease symptoms.
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Overall
Periodo de tiempo: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Parkinson's Disease Questionnaire (PDQ-39) Total. Range 0-100. Lower score indicates a better perceived health status.
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Emotional Well-Being
Periodo de tiempo: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Parkinson's Disease Questionnaire (PDQ-39) - Emotional Well-Being maximum score 24, minimum score of 0.Lower score indicates a better perceived health status.
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Short Form 36 Health Survey - Mental Component Summary
Periodo de tiempo: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Short Form 36 Health Survey. Range 0-100. Higher score indicates a better perceived quality of life.
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Short Form 36 Health Survey - Vitality
Periodo de tiempo: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Short Form 36 Health Survey - Vitality subscale ranges from 0-100. Higher score indicates a better perceived quality of life.
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Short Form 36 Health Survey - Role-Emotional
Periodo de tiempo: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Short Form 36 Health Survey - Emotional subscale ranges from 0-100. Higher score indicates a better perceived quality of life.
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Short Form 36 Health Survey - Mental Health
Periodo de tiempo: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Short Form 36 Health Survey - Mental Health subscale ranges from 0-100. Higher score indicates a better perceived quality of life.
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Irene Richard, MD, University of Rochester
  • Investigador principal: William McDonald, MD, Co-Principal Investigator--Emory University School of Medicine

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

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 junio de 2005

Finalización primaria (Actual)

1 de noviembre de 2009

Finalización del estudio (Actual)

1 de noviembre de 2009

Fechas de registro del estudio

Enviado por primera vez

28 de junio de 2004

Primero enviado que cumplió con los criterios de control de calidad

28 de junio de 2004

Publicado por primera vez (Estimar)

29 de junio de 2004

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

4 de enero de 2013

Última actualización enviada que cumplió con los criterios de control de calidad

3 de enero de 2013

Última verificación

1 de enero de 2013

Más información

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. .

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