Neural Correlates of Stress and Perceived Control in Adolescent Depression

NCT04788524 | Recruiting

• 1 other identifier: K23MH122668
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

stress; perceived control; neuroimaging; depression

Outcome Measures

Primary Outcomes (1)

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

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

  1.5 hour long scan during session 2

Secondary Outcomes (5)

• Cortisol Rating

  collected as part of 1.5 hour long scan during session 2

• 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)

• Stress Reactive Rumination 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 Arms (1)

Computer Task Manipulation

EXPERIMENTAL

Participants will complete computer tasks while undergoing an fMRI brain scan

Behavioral: Computer Task Manipulation

Interventions

Computer Task Manipulation BEHAVIORAL

Participants will complete computer tasks.

Computer Task Manipulation

Eligibility Criteria

• Age: 14 Years - 18 Years
• Gender Eligibility Details: Only female.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• 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);
• 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

You may not qualify if:

• 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;
• 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;
• \. 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)

Sponsors & Collaborators

• Mclean Hospital: lead

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Emily L Belleau, PhD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily L Belleau, PhD

CONTACT

6178554245; ebelleau@mclean.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Case-Control Design

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 9, 2021
• Study Start: April 23, 2021
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)