Neural Correlates of Stress and Perceived Control in Adolescent Depression (NCT04788524) | Clinical Trial Compass
RecruitingNot Applicable
Neural Correlates of Stress and Perceived Control in Adolescent Depression
United States80 participantsStarted 2021-04-23
Plain-language 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.
Who can participate
Age range
14 Years – 18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. Meet Diagnostic Statistical Manual-5th edition (DSM-5) diagnostic criteria for major depressive disorder (as diagnosed with the KSADS)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is measuring brain activity in specific regions like the ventral striatum and prefrontal cortex during stress tasks — can you help me understand what that means for my teen, and whether participating would involve any risks from the brain imaging process itself?
2Since this trial is listed as Phase NA, which suggests it's more of an observational or research study than a treatment trial, does participating offer my teenager any direct therapeutic benefit, or is the goal mainly to help researchers better understand adolescent depression?
3Given that this study focuses on stress and perceived control in adolescents with depression, what would my teen actually have to do during the study sessions, and how demanding or emotionally difficult might those tasks be for someone already struggling with their mental health?
4Would joining this research study in any way delay or interfere with my teenager starting standard depression treatment, like therapy or medication, and can they do both at the same time?
5If we decide this study isn't the right fit, what are the current standard treatment options you'd recommend for my teenager's major depressive disorder that we could pursue instead?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Blood-Oxygen-Level-Dependent Imaging (BOLD) activation of the ventral striatum and ventral medial prefrontal cortex
. 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);
Exclusion criteria
. 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;