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Computer-Based Intervention for Depression

N/A
Recruiting
Led By Emily L Belleau, PhD
Research Sponsored by Mclean Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No first-degree relatives with a history of depression, bipolar disorder, or psychosis
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);
Must not have
History of use of dopaminergic drugs (including methylphenidate)
History of head trauma with loss of consciousness
Timeline
Screening 3 weeks
Treatment Varies
Follow Up longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up)
Awards & highlights
No Placebo-Only Group

Summary

This trial will study how stress affects the brain's ability to process information related to perceived control among female adolescents with major depressive disorder, as well as how this may be linked to anhedonia (loss of pleasure) and maladaptive coping mechanisms.

Who is the study for?
This trial is for female adolescents aged 14-18 with major depressive disorder, not on psychotropic meds for at least 2 weeks, and no first-degree relatives with depression or bipolar. They must be right-handed, English-speaking, in the follicular phase of their menstrual cycle for fMRI scanning, and have a personal cell-phone.
What is being tested?
The study uses functional magnetic resonance imaging (fMRI) to understand how stress affects perceived control in the brain of adolescent females with depression. It involves a 'value of control task' during the scan to track neural responses.
What are the potential side effects?
Since this trial involves only an fMRI scan and computer tasks without medication intervention, there are minimal side effects expected beyond typical MRI-related discomforts such as claustrophobia or noise exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check β€œYes” for the criteria below
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None of my immediate family has had depression, bipolar disorder, or psychosis.
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I haven't taken any mental health medications for the required time.
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I am between 14 and 18 years old.
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I haven't taken any mental health medications for the required time.
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I am between 14 and 18 years old.
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I am fluent in English.

Exclusion Criteria

You may be eligible for the trial if you check β€œNo” for criteria below:
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I have taken medication that affects dopamine levels.
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I have had a head injury that made me lose consciousness.
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I am currently using hormonal replacement therapy, anabolic steroids, or hormonal contraception.
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I have undergone electroconvulsive therapy in the past.
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I have a history of seizures.
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I don't have conditions or implants that prevent MRI scans.
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I do not have any serious or unstable illnesses affecting my heart, liver, kidneys, lungs, hormones, nervous system, or blood.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up)
This trial's timeline: 3 weeks for screening, Varies for treatment, and longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Blood-Oxygen-Level-Dependent Imaging (BOLD) activation of the ventral striatum and ventral medial prefrontal cortex
Secondary study objectives
Cortisol Rating
Mood Rating
Positive Affect Score
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Computer Task ManipulationExperimental Treatment1 Intervention
Participants will complete computer tasks while undergoing an fMRI brain scan

Find a Location

Who is running the clinical trial?

Mclean HospitalLead Sponsor
216 Previous Clinical Trials
21,793 Total Patients Enrolled
46 Trials studying Depression
3,599 Patients Enrolled for Depression
Emily L Belleau, PhDPrincipal InvestigatorMclean Hospital

Media Library

Computer Task Manipulation Clinical Trial Eligibility Overview. Trial Name: NCT04788524 β€” N/A
Depression Research Study Groups: Computer Task Manipulation
Depression Clinical Trial 2023: Computer Task Manipulation Highlights & Side Effects. Trial Name: NCT04788524 β€” N/A
Computer Task Manipulation 2023 Treatment Timeline for Medical Study. Trial Name: NCT04788524 β€” N/A
~8 spots leftby Apr 2025