Neural Correlates of Stress and Perceived Control in Adolescent Depression

Major Depressive Disorder Clinical Trial

Official title:

Neural Correlates of Stress and Perceived Control in Adolescent Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04788524
• Other study ID #: K23MH122668
• Status: Recruiting
• Phase: N/A
• Start date: April 23, 2021
• Est. completion date: April 30, 2025

Study information

• Verified date: April 2022
• Source: Mclean Hospital
• Contact: Emily L Belleau, PhD
• Phone: 6178554245
• Email: ebelleau[@]mclean.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Behavioral:
• Computer Task Manipulation
Participants will complete computer tasks.

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Mclean Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1.5 hour long scan during session 2
Secondary	Cortisol Rating	Saliva rating to be collected throughout the fMRI brain scan	collected as part of 1.5 hour long scan during session 2
Secondary	Mood Rating	Self-reported mood rating to be collected throughout the fMRI brain scan	collected as part of 1.5 hour long scan during session 2
Secondary	Stress Reactivity Score	Stress Reactivity Survey Item collected via smart-phone delivered ecological momentary assessment	Longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up)
Secondary	Stress Reactive Rumination Score	Stress Reactive Rumination Scale collected via smart-phone delivered ecological momentary assessment	Longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up)
Secondary	Positive Affect Score	Positive Affect Survey Items collected via smart-phone delivered ecological momentary assessment	Longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up)