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Clinical Trials/NCT04788524
NCT04788524
Recruiting
Not Applicable

Neural Correlates of Stress and Perceived Control in Adolescent Depression

Mclean Hospital1 site in 1 country80 target enrollmentApril 23, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Major Depressive Disorder
Sponsor
Mclean Hospital
Enrollment
80
Locations
1
Primary Endpoint
Blood-Oxygen-Level-Dependent Imaging (BOLD) activation of the ventral striatum and ventral medial prefrontal cortex
Status
Recruiting
Last Updated
12 months ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
April 23, 2021
End Date
April 30, 2026
Last Updated
12 months ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Emily L. Belleau

Principal Investigator

Mclean Hospital

Eligibility Criteria

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);

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);

Outcomes

Primary Outcomes

Blood-Oxygen-Level-Dependent Imaging (BOLD) activation of the ventral striatum and ventral medial prefrontal cortex

Time Frame: 1.5 hour long scan during session 2

BOLD activation of frontostriatal regions in response to computer tasks performed during the fMRI Brian scan

Secondary Outcomes

  • Cortisol Rating(collected as part of 1.5 hour long scan during session 2)
  • Stress Reactive Rumination Score(Longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up))
  • Mood Rating(collected as part of 1.5 hour long scan during session 2)
  • Stress Reactivity Score(Longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up))
  • Positive Affect Score(Longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up))

Study Sites (1)

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