Translational Research Evaluating Neurocognitive Memory Processes (TREC-MP)
The purpose of this study is to evaluate the psychometric properties and utility of new, computerized, neurocognitive measures in humans with depression, and humans with depression undergoing electroconvulsive therapy (ECT). The benefits of the study outweigh the risk as there is the possibility of developing better computerized neurocognitive measures, and the risks are limited to no more than minimal test related fatigue and psychological stress.
Depressed humans, depressed human participants undergoing ECT, and humans diagnosed with Parkinson's disease (age 18-85) will be invited to participate in this study. After providing informed consent participants will undergo a clinical psychiatric evaluation to confirm the inclusion/exclusion criteria. After the clinical psychiatric evaluation, participants will complete common and new neurocognitive measures. There will be a total of two testing visits (baseline, 1-month follow-up). The anticipated duration of the participant's involvement is no more than 2 study visits that can take place over a 4-day period (i.e., the clinical evaluation can occur on day 1 and the neuropsychological measures can be administered on day 2 of each study visit) equating to approximately 6-hours (3-hours each day) per study visit.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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North Carolina
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Durham, North Carolina, Estados Unidos, 27710
- Duke Universtiy Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:Depressed Individuals
- Male and female subjects, age 18-85
- DSM-IV-TR diagnosis of major depressive episode, unipolar, confirmed by the MINI-PLUS [221]
- HRSD24 total score > 10
- MMSE total score > 26
- Graduated from high school
- Competent to provide informed consent
Inclusion Criteria:Depressed Individuals Receiving ECT
- Same as for Depressed Cohort Inclusion Criteria (see above)
- Referred for ECT
- Subject competent to provide informed consent
Inclusion Criteria:Individuals Diagnosed with PD
- Male and female subjects, age 18-85
- Diagnosed with PD
- MMSE total score > 20
- Graduate high school
- Subject competent to provide informed consent
Exclusion Criteria:Depressed Individuals/Depressed Individuals Receiving ECT
- Lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder, or mental retardation
- Current neurostimulation treatment (e.g., ECT, MST, rTMS, vagus nerve stimulation, deep brain stimulation)
- Current alcohol abuse or dependence within past 12 months
- Current substance abuse or dependence within past 12 months
- Lifetime mental retardation
- History of central nervous system (CNS) disease
- Current diagnosis of dementia or delirium
- Current visual, auditory, or motor impairment that compromises ability to take tests
- Unable to read or comprehend English
Exclusion Criteria:Individuals Diagnosed with PD
- Lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder, or mental retardation
- Current neurostimulation treatment (e.g., ECT, MST, rTMS, vagus nerve stimulation, deep brain stimulation)
- Current alcohol abuse or dependence within past 12 months
- Current substance abuse or dependence within past 12 months
- Lifetime mental retardation
- History of central nervous system (CNS) disease other than Parkinson's Disease
- Current diagnosis of dementia or delirium
- Current visual, auditory, or motor impairment that compromises ability to take tests
- Unable to read or comprehend English
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Healthy Human
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Depressed Human
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Depressed Human, Undergoing Electroconvulsive Therapy
Electroconvulsive Therapy is being received as standard of care, not as a study intervention.
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Human Diagnosed with Parkinson's Disease
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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California Verbal Learning Test-II
Periodo de tiempo: Baseline
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The California Verbal Learning Test-II (CVLT-II) is a standard neuropsychological instrument that assesses verbal learning and memory.
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Baseline
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California Verbal Learning Test-II
Periodo de tiempo: 1-Month Follow-up
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The California Verbal Learning Test-II (CVLT-II) is a standard neuropsychological instrument that assesses verbal learning and memory.
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1-Month Follow-up
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Shawn McClintock, PhD, Duke University
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
Otros números de identificación del estudio
- Pro00039288
- 5K23MH087739-03 (Subvención/contrato del NIH de EE. UU.)
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