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Neural Correlates of Stress and Perceived Control in Adolescent Depression

21 de abril de 2022 actualizado por: Emily L. Belleau, Mclean Hospital
Lack of perceived control, particularly during stress, has been critically implicated in major depressive disorder (MDD) and anhedonic symptoms, especially among female adolescents; yet the neural underpinnings of perceived control disruptions in MDD remain poorly understood. Using functional magnetic resonance imaging with a novel "value of control task" in conjunction with a prospective design, this study will provide a comprehensive understanding of stress and perceived control related mechanisms in female adolescents with MDD and will examine stress-induced disruptions in perceived control as a predictor of "real world" expressions of maladaptive coping and anhedonia.

Descripción general del estudio

Estado

Reclutamiento

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

Intervencionista

Inscripción (Anticipado)

80

Fase

  • No aplica

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.

Estudio Contacto

Ubicaciones de estudio

    • Massachusetts
      • Belmont, Massachusetts, Estados Unidos, 02478
        • Reclutamiento
        • McLean Hospital
        • Contacto:
        • Investigador principal:
          • Emily L Belleau, PhD

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

14 años a 18 años (Niño, Adulto)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Femenino

Descripción

Inclusion Criteria:

  • Inclusion Criteria: All Participants

    1. Females of all ethnic origins See Section: Inclusion of Women and Minorities);
    2. Ages 14-18 (See Section: Inclusion of Children);
    3. Written informed assent/consent from adolescent and parent/guardian (if under age 18);
    4. English as a first language or English fluency;
    5. Right handed111;
    6. 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

  1. Meet Diagnostic Statistical Manual-5th edition (DSM-5) diagnostic criteria for major depressive disorder (as diagnosed with the KSADS)
  2. 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

  1. No history or current diagnosis of any DSM-5 psychiatric or substance/alcohol-related disorder (as diagnosed with the KSADS)
  2. No first-degree relatives with a history of depression, bipolar disorder, or psychosis

Exclusion Criteria:

  • Exclusion Criteria: All Participants

    1. History of head trauma with loss of consciousness;
    2. History of seizure disorder;
    3. Serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease;
    4. History of cocaine or stimulant use (e.g., amphetamine, cocaine, methamphetamine);
    5. History of use of dopaminergic drugs (including methylphenidate);
    6. Use of hormonal replacement therapy, anabolic steroids, or hormonal contraception;
    7. Clinical or laboratory evidence of hypothyroidism;
    8. Systemic medical or neurological illness that could impact fMRI measures of cerebral blood flow;
    9. 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);
    10. Pregnancy
    11. 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;
    12. History of electroconvulsive therapy
    13. 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

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: 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
Participants will complete computer tasks.

¿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
BOLD activation of frontostriatal regions in response to computer tasks performed during the fMRI Brian scan
1.5 hour long scan during session 2

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
Saliva rating to be collected throughout the fMRI brain scan
collected as part of 1.5 hour long scan during session 2
Mood Rating
Periodo de tiempo: collected as part of 1.5 hour long scan during session 2
Self-reported mood rating to be collected throughout the fMRI brain scan
collected as part of 1.5 hour long scan during session 2
Stress Reactivity Score
Periodo de tiempo: Longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up)
Stress Reactivity Survey Item collected via smart-phone delivered ecological momentary assessment
Longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up)
Stress Reactive Rumination Score
Periodo de tiempo: Longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up)
Stress Reactive Rumination Scale collected via smart-phone delivered ecological momentary assessment
Longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up)
Positive Affect Score
Periodo de tiempo: Longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up)
Positive Affect Survey Items collected via smart-phone delivered ecological momentary assessment
Longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up)

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Investigador principal: Emily L Belleau, PhD, McLean Hospital

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 (Actual)

23 de abril de 2021

Finalización primaria (Anticipado)

30 de abril de 2025

Finalización del estudio (Anticipado)

30 de abril de 2025

Fechas de registro del estudio

Enviado por primera vez

3 de marzo de 2021

Primero enviado que cumplió con los criterios de control de calidad

8 de marzo de 2021

Publicado por primera vez (Actual)

9 de marzo de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de abril de 2022

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

21 de abril de 2022

Última verificación

1 de abril de 2022

Más información

Términos relacionados con este estudio

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)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .

Ensayos clínicos sobre Computer Task Manipulation

3
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