NCT04788524 Neural Correlates of Stress and Perceived Control in Adolescent Depression
| NCT ID | NCT04788524 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mclean Hospital |
| Condition | Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2021-04-23 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2021-04-23 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
Emily L Belleau, PhD
PRINCIPAL INVESTIGATOR
Mclean Hospital
Frequently Asked Questions
Who can join the NCT04788524 clinical trial?
This trial is open to female participants only, aged 14 Years or older, up to 18 Years, studying Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04788524 currently recruiting?
Yes, NCT04788524 is actively recruiting participants. Contact the research team at ebelleau@mclean.harvard.edu for enrollment information.
Where is the NCT04788524 trial being conducted?
This trial is being conducted at Belmont, United States.
Who is sponsoring the NCT04788524 clinical trial?
NCT04788524 is sponsored by Mclean Hospital. The principal investigator is Emily L Belleau, PhD at Mclean Hospital. The trial plans to enroll 80 participants.