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Neural Correlates of Stress and Perceived Control in Adolescent Depression

Primary Purpose

Major Depressive Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computer Task Manipulation
Sponsored by
Mclean Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Major Depressive Disorder focused on measuring stress, perceived control, neuroimaging, depression

Eligibility Criteria

14 Years - 18 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • McLean HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Computer Task Manipulation

Arm Description

Participants will complete computer tasks while undergoing an fMRI brain scan

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cortisol Rating
Saliva rating to be collected throughout the fMRI brain scan
Mood Rating
Self-reported mood rating to be collected throughout the fMRI brain scan
Stress Reactivity Score
Stress Reactivity Survey Item collected via smart-phone delivered ecological momentary assessment
Stress Reactive Rumination Score
Stress Reactive Rumination Scale collected via smart-phone delivered ecological momentary assessment
Positive Affect Score
Positive Affect Survey Items collected via smart-phone delivered ecological momentary assessment

Full Information

First Posted
March 3, 2021
Last Updated
April 21, 2022
Sponsor
Mclean Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04788524
Brief Title
Neural Correlates of Stress and Perceived Control in Adolescent Depression
Official Title
Neural Correlates of Stress and Perceived Control in Adolescent Depression
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 23, 2021 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mclean Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
stress, perceived control, neuroimaging, depression

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Case-Control Design
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Computer Task Manipulation
Arm Type
Experimental
Arm Description
Participants will complete computer tasks while undergoing an fMRI brain scan
Intervention Type
Behavioral
Intervention Name(s)
Computer Task Manipulation
Intervention Description
Participants will complete computer tasks.
Primary Outcome Measure Information:
Title
Blood-Oxygen-Level-Dependent Imaging (BOLD) activation of the ventral striatum and ventral medial prefrontal cortex
Description
BOLD activation of frontostriatal regions in response to computer tasks performed during the fMRI Brian scan
Time Frame
1.5 hour long scan during session 2
Secondary Outcome Measure Information:
Title
Cortisol Rating
Description
Saliva rating to be collected throughout the fMRI brain scan
Time Frame
collected as part of 1.5 hour long scan during session 2
Title
Mood Rating
Description
Self-reported mood rating to be collected throughout the fMRI brain scan
Time Frame
collected as part of 1.5 hour long scan during session 2
Title
Stress Reactivity Score
Description
Stress Reactivity Survey Item collected via smart-phone delivered ecological momentary assessment
Time Frame
Longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up)
Title
Stress Reactive Rumination Score
Description
Stress Reactive Rumination Scale collected via smart-phone delivered ecological momentary assessment
Time Frame
Longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up)
Title
Positive Affect Score
Description
Positive Affect Survey Items collected via smart-phone delivered ecological momentary assessment
Time Frame
Longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up)

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only female.
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily L Belleau, PhD
Phone
6178554245
Email
ebelleau@mclean.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily L Belleau, PhD
Organizational Affiliation
Mclean Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily L Belleau, PhD
Phone
617-855-4245
Email
ebelleau@mclean.harvard.edu
First Name & Middle Initial & Last Name & Degree
Emily L Belleau, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Neural Correlates of Stress and Perceived Control in Adolescent Depression

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