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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 βYesβ for the criteria belowSelect...
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 βNoβ for criteria below:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up)
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 moreAwards & 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman.I have taken medication that affects dopamine levels.None of my immediate family has had depression, bipolar disorder, or psychosis.I have had a head injury that made me lose consciousness.I am currently using hormonal replacement therapy, anabolic steroids, or hormonal contraception.Adolescents must provide written informed assent if they are older than age 7 and younger than age 18, and a parent or guardian must provide written informed consent if the adolescent is younger than age 7.I haven't taken any mental health medications for the required time.You have used drugs like cocaine, amphetamine, or methamphetamine in the past.I have a condition that could affect brain blood flow measurements.I have undergone electroconvulsive therapy in the past.I am between 14 and 18 years old.I have a history of seizures.I haven't taken any mental health medications for the required time.You are included if you meet the inclusion criteria.My main diagnosis is depression, but I may also have certain anxiety disorders because of it.You have been diagnosed with major depressive disorder according to the DSM-5 criteria.I don't have conditions or implants that prevent MRI scans.I am a woman.I am between 14 and 18 years old.I am fluent in English.I do not have any serious or unstable illnesses affecting my heart, liver, kidneys, lungs, hormones, nervous system, or blood.You are right-handed.
Research Study Groups:
This trial has the following groups:- Group 1: Computer Task Manipulation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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