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NCT Number: NCT04788524

Neural Correlates of Stress and Perceived Control in Adolescent Depression

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.

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Key information

Age range

14 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location status: Recruiting

Location contact

Emily L Belleau, PhD

CONTACT

[email protected]

617-855-4245

Emily L Belleau, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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)

Treatment and study plan

Computer Task Manipulation

Behavioral

Participants will complete computer tasks.

Primary outcomes

  1. 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

  1. Cortisol Rating

    Time frame: collected as part of 1.5 hour long scan during session 2

    Saliva rating to be collected throughout the fMRI brain scan

  2. Mood Rating

    Time frame: collected as part of 1.5 hour long scan during session 2

    Self-reported mood rating to be collected throughout the fMRI brain scan

  3. Stress Reactivity Score

    Time frame: 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

  4. Stress Reactive Rumination Score

    Time frame: 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

  5. Positive Affect Score

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Emily L Belleau, PhD

CONTACT

[email protected]

6178554245

Sponsors and collaborators

Lead sponsor

Mclean Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Mar 9, 2021
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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