Major Depressive DisorderNCT04788524
Neural Correlates of Stress and Perceived Control in Adolescent Depression
A study testing Computer Task Manipulation in people with Major Depressive Disorder, run by Mclean Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Computer Task Manipulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2021to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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;
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- 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
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
McLean Hospital
Belmont, Massachusetts, 02478
Emily L Belleau, PhD, 617-855-4245, ebelleau@mclean.harvard.edu
Emily L Belleau, PhD
About this study
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.
Read the 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
- Being tested
- Computer Task Manipulation
- Keywords
- stress, perceived control, neuroimaging, depression
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer Task ManipulationBehavioural
Participants will complete computer tasks.
| Study group | Role | What they receive |
|---|---|---|
| Computer Task Manipulation | Experimental | Participants will complete computer tasks while undergoing an fMRI brain scan Receives: Behavioral: Computer Task Manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1.5 hour long scan during session 2
Secondary outcomes (5)
Cortisol Rating
Saliva rating to be collected throughout the fMRI brain scan
Measured: collected as part of 1.5 hour long scan during session 2
Mood Rating
Self-reported mood rating to be collected throughout the fMRI brain scan
Measured: collected as part of 1.5 hour long scan during session 2
Stress Reactivity Score
Stress Reactivity Survey Item collected via smart-phone delivered ecological momentary assessment
Measured: Longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up)
Stress Reactive Rumination Score
Stress Reactive Rumination Scale collected via smart-phone delivered ecological momentary assessment
Measured: Longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up)
Positive Affect Score
Positive Affect Survey Items collected via smart-phone delivered ecological momentary assessment
Measured: Longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start23 Apr 2021
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Case-Control Design
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily L. Belleau, Mclean Hospital
- Investigators
- Emily L Belleau, PhD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788524
- Sponsor's protocol ID
- K23MH122668
- Status last verified
- May 2026
- First submitted
- 3 Mar 2021
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Correlates of Stress and Perceived Control in Adolescent Depression
- ClinicalTrials.gov ID
- NCT04788524
- Acronym / sponsor ID
- K23MH122668
- Conditions
- Major Depressive Disorder
- Keywords
- stress, perceived control, neuroimaging, depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- 23 Apr 2021 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Case-Control Design
| Arm | Type | Receives |
|---|---|---|
| Computer Task Manipulation | Experimental | Behavioral: Computer Task ManipulationParticipants will complete computer tasks while undergoing an fMRI brain scan |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer Task ManipulationParticipants will complete computer tasks. | Behavioural | Computer Task Manipulation |
Primary outcome
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
5 secondary outcomes
Cortisol Rating
Time frame: collected as part of 1.5 hour long scan during session 2
Mood Rating
Time frame: collected as part of 1.5 hour long scan during session 2
Stress Reactivity Score
Time frame: Longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up)
Stress Reactive Rumination Score
Time frame: Longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up)
Positive Affect Score
Time frame: Longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emily L Belleau, PhD principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer Task Manipulation in people with Major Depressive Disorder, run by Mclean Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily L Belleau, PhD (6178554245, ebelleau@mclean.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.