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New treatment option for Major Depressive Disorder
Official title Neural Correlates of Stress and Perceived Control in Adolescent Depression
ClinicalTrials.gov ID: NCT04788524
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 18, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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;
You likely can't join if
- 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);
See the full eligibility 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...
- 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); 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: 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Belmont, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 14 years to 18 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Belmont, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.