Recruiting

Observational Study

Sponsor:

Mclean Hospital

Code:

NCT04788524

Conditions

Major Depressive Disorder

Eligibility Criteria

Sex: Female

Age: 14 - 18

Healthy Volunteers: Accepted

Interventions

Computer Task Manipulation

Study Details

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

Study ID

NCT04788524

Start date

Apr 23, 2021

Status verified date

May, 2026

Completion date

Oct 31, 2026

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 14 - 18

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Computer Task Manipulation

Participants will complete computer tasks while undergoing an fMRI brain scan

Interventions

Computer Task Manipulation

Participants will complete computer tasks.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

McLean Hospital

Recruiting

Belmont, Massachusetts, United States, 02478

Contacts

Principal Investigator:

Emily L Belleau, PhD

More Information

Sponsor

Mclean Hospital

Last update posted

May 19, 2026

Last verified

May, 2026

Keywords

  • stress
  • perceived control
  • neuroimaging
  • depression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mclean Hospital on 2026-05-19.