- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00086190
Study of Antidepressants in Parkinson's Disease (SAD-PD)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
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
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Ontario
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London, Ontario, Canadá, N6A 5A5
- London Health Sciences Centre, University Campus Room A10-325, 339 Windermere Road
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Quebec
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Montreal, Quebec, Canadá, H2W 1T8
- Hotel-Dieu Hospital-CHUM
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California
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San Francisco, California, Estados Unidos, 94143
- University of California San Francisco
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Florida
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Gainesville, Florida, Estados Unidos, 32610
- University of Florida
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Miami, Florida, Estados Unidos, 33136
- University of Miami
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Emory University School of Medicine
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40536
- University of Kentucky
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Maryland
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Baltimore, Maryland, Estados Unidos, 21218
- Johns Hopkins University
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Baltimore, Maryland, Estados Unidos, 21250
- University of Maryland
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- Beth Israel Deaconess Medical Center, Dept. of Neurology E/KS 430, 330 Brookline Avenue
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Missouri
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St. Louis, Missouri, Estados Unidos, 63110
- Washington University School of Medicine
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New York
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Rochester, New York, Estados Unidos, 14627
- University of Rochester
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Ohio
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Toledo, Ohio, Estados Unidos
- Medical University of Ohio
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Oregon
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Portland, Oregon, Estados Unidos, 97239
- Oregon Health Sciences University
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Tennessee
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Memphis, Tennessee, Estados Unidos, 38163
- University of Tennessee-Memphis
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Texas
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Houston, Texas, Estados Unidos, 77030
- Baylor College of Medicine, 6550 Fannin, Suite 1801
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Virginia
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Charlottesville, Virginia, Estados Unidos, 22901
- University of Virginia
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San Juan, Puerto Rico, 00936
- University of Puerto Rico
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
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
¿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 |
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Comparador activo: paroxetine
Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
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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:
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Comparador activo: venlafaxine extended release
Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
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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:
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Comparador de placebos: placebo
Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
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una sustancia inactiva
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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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
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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.
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from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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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
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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.
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from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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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
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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.
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from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Change in Geriatric Depression Rating Scale (GDS)
Periodo de tiempo: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Geriatric Depression Scale ranges from 0-30.
Higher score indicates more severe depression.
0-9 normal, 10-19 mild depression, 20-30 severe depression.
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from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Change in Brief Psychiatric Rating Scale (BPRS)
Periodo de tiempo: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Brief Psychiatric Rating Scale.
Maximum score 126.
Higher score indicates greater psychiatric difficulties.
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from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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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
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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.
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from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Change in Snaith Clinical Anxiety Scale (CAS)
Periodo de tiempo: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Snaith Clinical Anxiety Scale.
Range 0-21.
Higher scores indicate increased anxiety.
Score greater than 8 indicates clinical anxiety.
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from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Change in Pittsburgh Sleep Quality Index (PSQI)
Periodo de tiempo: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Pittsburgh Sleep Quality Index scores range from 0-21, with higher scores indicating severe sleep difficulties.
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from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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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
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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.
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from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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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
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Unified Parkinson's Disease Rating Scale - Tremor subscale ranges from 0-23.
Higher score indicates more severe Parkinson's disease symptoms.
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from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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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
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Unified Parkinson's Disease Rating Scale - Bulbar maximum score 24, minimum score of 0. Higher score indicates more severe Parkinson's disease symptoms.
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from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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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
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Parkinson's Disease Questionnaire (PDQ-39) Total.
Range 0-100.
Lower score indicates a better perceived health status.
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from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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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
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Parkinson's Disease Questionnaire (PDQ-39) - Emotional Well-Being maximum score 24, minimum score of 0.Lower score indicates a better perceived health status.
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from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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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
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Short Form 36 Health Survey.
Range 0-100.
Higher score indicates a better perceived quality of life.
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from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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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
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Short Form 36 Health Survey - Vitality subscale ranges from 0-100.
Higher score indicates a better perceived quality of life.
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from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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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
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Short Form 36 Health Survey - Emotional subscale ranges from 0-100.
Higher score indicates a better perceived quality of life.
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from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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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
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Short Form 36 Health Survey - Mental Health subscale ranges from 0-100.
Higher score indicates a better perceived quality of life.
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from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Colaboradores e Investigadores
Patrocinador
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
Publicaciones Generales
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Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Síntomas de comportamiento
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Trastornos Parkinsonianos
- Enfermedades de los ganglios basales
- Trastornos del movimiento
- Sinucleinopatías
- Enfermedades neurodegenerativas
- Depresión
- Enfermedad de Parkinson
- Efectos fisiológicos de las drogas
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Drogas psicotropicas
- Inhibidores de la captación de serotonina
- Inhibidores de la captación de neurotransmisores
- Moduladores de transporte de membrana
- Agentes de serotonina
- Agentes antidepresivos
- Inhibidores de enzimas del citocromo P-450
- Agentes antidepresivos, segunda generación
- Inhibidores de la recaptación de serotonina y noradrenalina
- Inhibidores del citocromo P-450 CYP2D6
- Paroxetina
- Clorhidrato de venlafaxina
Otros números de identificación del estudio
- R01NS046487 (Subvención/contrato del NIH de EE. UU.)
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