Neural Correlates of Stress and Perceived Control in Adolescent Depression

NCT ID: NCT04788524

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-23
• Study Completion Date: 2026-04-30

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Computer Task Manipulation

Participants will complete computer tasks while undergoing an fMRI brain scan

Group Type: EXPERIMENTAL

Computer Task Manipulation

Intervention Type: BEHAVIORAL

Participants will complete computer tasks.

Interventions

Computer Task Manipulation

Participants will complete computer tasks.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

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);

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

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;

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;

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)

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mclean Hospital

OTHER

Sponsor Role: lead

Responsible Party

Emily L. Belleau

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emily L Belleau, PhD

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Locations

McLean Hospital

Belmont, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Emily L Belleau, PhD

Role: CONTACT

ebelleau@mclean.harvard.edu

6178554245

Facility Contacts

Emily L Belleau, PhD

Role: primary

ebelleau@mclean.harvard.edu

617-855-4245

Other Identifiers

K23MH122668

Identifier Type: NIH

Identifier Source: org_study_id

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