- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04788524
Neural Correlates of Stress and Perceived Control in Adolescent Depression
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Participants in this research will include 40 female adolescents, aged 14-18, with Major Depressive Disorder (MDD) and 40 healthy adolescents from the greater Boston area by Dr. Emily Belleau, at McLean Hospital's Center for Depression, Anxiety and Stress Research.
The study will include four sessions:
- A clinical diagnostic interview as well as filling out a series of questionnaires and assessments.
- The second session will include a functional magnetic resonance imaging (fMRI) brain scan to be conducted at the McLean Hospital Imaging Center. Participants will be asked to respond to surveys on their cell phone in the week following the fMRI brain scan.
- The third session will include a diagnostic interview, assessments, and questionnaires to be completed three-months after the fMRI brain scan. Participants will be asked to complete surveys on their cell phone during the week following this three month follow-up session.
- The fourth session will include a diagnostic interview, assessments, and questionnaires to be completed six-months after the fMRI brain scan. Participants will be asked to complete surveys on their cell phone during the week following this six month follow-up session.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Emily L Belleau, PhD
- Número de teléfono: 6178554245
- Correo electrónico: ebelleau@mclean.harvard.edu
Ubicaciones de estudio
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Massachusetts
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Belmont, Massachusetts, Estados Unidos, 02478
- Reclutamiento
- McLean Hospital
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Contacto:
- Emily L Belleau, PhD
- Número de teléfono: 617-855-4245
- Correo electrónico: ebelleau@mclean.harvard.edu
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Investigador principal:
- Emily L Belleau, PhD
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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:
Inclusion Criteria: All Participants
- Females of all ethnic origins See Section: Inclusion of Women and Minorities);
- Ages 14-18 (See Section: Inclusion of Children);
- Written informed assent/consent from adolescent and parent/guardian (if under age 18);
- English as a first language or English fluency;
- Right handed111;
- Personal cell-phone (for Ecological Momentary Assessment [EMA]) 7 All participants will be in the follicular phase of their menstrual cycle when completing the functional magnetic resonance imaging (fMRI) study session
Inclusion Criteria: MDD Sample
- Meet Diagnostic Statistical Manual-5th edition (DSM-5) diagnostic criteria for major depressive disorder (as diagnosed with the KSADS)
- Absence of any psychotropic medications for at least 2 weeks (6 weeks for fluoxetine; 6 months for neuroleptics; 2 weeks for benzodiazepines; 2 weeks for any other antidepressants);
Inclusion Criteria: Healthy Control (HC) Sample
- No history or current diagnosis of any DSM-5 psychiatric or substance/alcohol-related disorder (as diagnosed with the KSADS)
- No first-degree relatives with a history of depression, bipolar disorder, or psychosis
Exclusion Criteria:
Exclusion Criteria: All Participants
- History of head trauma with loss of consciousness;
- History of seizure disorder;
- Serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease;
- History of cocaine or stimulant use (e.g., amphetamine, cocaine, methamphetamine);
- History of use of dopaminergic drugs (including methylphenidate);
- Use of hormonal replacement therapy, anabolic steroids, or hormonal contraception;
- Clinical or laboratory evidence of hypothyroidism;
- Systemic medical or neurological illness that could impact fMRI measures of cerebral blood flow;
- Failure to meet standard exclusion criteria for fMRI scanning (e.g., claustrophobia, cardiac pacemakers, neural pacemakers, surgically implanted metal devices, cochlear implants, metal braces, or other metal objects in the body);
- Pregnancy
- Testing positive on a drug test on the day of the scan which testis for stimulants, marijuana, barbiturates, benzodiazepine, buprenorphine, 3,4-Methyl enedioxy methamphetamine (MDMA), methadone, opiates, oxycodone, phencyclidine;
- History of electroconvulsive therapy
- Participants with suicidal ideation where study participation is deemed unsafe by the study clinician;
Additional Exclusion Criteria: Major Depressive Disorder (MDD) Sample
1. Major depressive disorder diagnosis secondary to another disorder (selected comorbid anxiety disorders such as generalized anxiety disorder, specific phobia, and social anxiety disorders are allowed if they are secondary to MDD)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Computer Task Manipulation
Participants will complete computer tasks while undergoing an fMRI brain scan
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Participants will complete computer tasks.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Blood-Oxygen-Level-Dependent Imaging (BOLD) activation of the ventral striatum and ventral medial prefrontal cortex
Periodo de tiempo: 1.5 hour long scan during session 2
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BOLD activation of frontostriatal regions in response to computer tasks performed during the fMRI Brian scan
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1.5 hour long scan during session 2
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Cortisol Rating
Periodo de tiempo: collected as part of 1.5 hour long scan during session 2
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Saliva rating to be collected throughout the fMRI brain scan
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collected as part of 1.5 hour long scan during session 2
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Mood Rating
Periodo de tiempo: collected as part of 1.5 hour long scan during session 2
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Self-reported mood rating to be collected throughout the fMRI brain scan
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collected as part of 1.5 hour long scan during session 2
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Stress Reactivity Score
Periodo de tiempo: Longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up)
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Stress Reactivity Survey Item collected via smart-phone delivered ecological momentary assessment
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Longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up)
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Stress Reactive Rumination Score
Periodo de tiempo: Longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up)
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Stress Reactive Rumination Scale collected via smart-phone delivered ecological momentary assessment
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Longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up)
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Positive Affect Score
Periodo de tiempo: Longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up)
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Positive Affect Survey Items collected via smart-phone delivered ecological momentary assessment
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Longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Emily L Belleau, PhD, McLean Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
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
Otros números de identificación del estudio
- K23MH122668 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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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