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Behavioral Intervention
Neurofeedback for Depression
N/A
Recruiting
Led By Yvette I Sheline, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult aged 18 - 65 meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for MDD according to the Clinician-Administered MDD Scale for DSM-5 (unipolar depression or bipolar II depressed)
Normal cognition
Must not have
Use of psychoactive medication (including antidepressants) or currently in therapy
Outside age range
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Summary
This trial tests a new therapy that uses brain scans to help patients with depression change their focus from negative to positive. It targets people with Major Depressive Disorder who often dwell on negative thoughts. The therapy provides real-time feedback and adjusts tasks to reduce negative focus.
Who is the study for?
Adults aged 18-65 with Major Depressive Disorder (MDD) as per DSM-5, scoring at least 16 on the MADRS scale for depression severity. Participants must have normal cognition, understand English, and consent to join. Excluded are pregnant women, those outside the age range or with MRI contraindications like metal implants or claustrophobia, neurological issues affecting brain data or causing depression, recent substance abuse, non-correctable vision loss, active suicide risk or current psychoactive medication use.
What is being tested?
The trial is testing a new therapy using real-time fMRI neurofeedback aimed at reducing negative attention bias in MDD patients. It involves decoding a patient's attentional state and adjusting task stimuli accordingly. The study compares actual neurofeedback against sham feedback to determine its effectiveness.
What are the potential side effects?
Since this is a psychological intervention involving fMRI scans and no drugs are administered directly for the treatment being tested in this trial; there may not be typical 'side effects' as seen with medications. However participants might experience discomfort from lying still during an MRI scan.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old and have been diagnosed with major depressive disorder.
Select...
My thinking and memory skills are normal.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking medication for my mental health or am in therapy.
Select...
I am outside the specified age range for the trial.
Select...
I have permanent vision loss that cannot be corrected.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Attention Mechanism of Depression
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active NeurofeedbackActive Control1 Intervention
R61 Phase: Four training sessions. Each training session contains 32 minutes of active neurofeedback runs.
R33 Phase: Number of training sessions are contingent on R61 findings.
Group II: Sham NeurofeedbackPlacebo Group1 Intervention
R61 Phase: Four training sessions. Each training session contains 32 minutes of sham (placebo) neurofeedback runs.
R33 Phase: Number of training sessions are contingent on R61 findings.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for depression include pharmacotherapy, cognitive-behavioral therapy (CBT), mindfulness-based cognitive therapy (MBCT), and neurofeedback therapy. Antidepressants work by altering neurotransmitter levels in the brain to improve mood and emotional state.
CBT helps patients identify and change negative thought patterns and behaviors. MBCT combines mindfulness practices with cognitive therapy to help patients become more aware of their thoughts and feelings and reduce relapse.
Neurofeedback therapy, such as real-time fMRI neurofeedback, trains patients to modulate their brain activity, specifically targeting attentional states to reduce negative attention bias. Understanding these mechanisms is crucial for patients as it helps them make informed decisions about their treatment options and tailor therapies to their specific needs.
A mechanistic model for individualised treatment of anxiety disorders based on predictive neural biomarkers.International Union of Basic and Clinical Pharmacology CIV: The Neurobiology of Treatment-resistant Depression: From Antidepressant Classifications to Novel Pharmacological Targets.Electroencephalographic neurofeedback: Level of evidence in mental and brain disorders and suggestions for good clinical practice.
A mechanistic model for individualised treatment of anxiety disorders based on predictive neural biomarkers.International Union of Basic and Clinical Pharmacology CIV: The Neurobiology of Treatment-resistant Depression: From Antidepressant Classifications to Novel Pharmacological Targets.Electroencephalographic neurofeedback: Level of evidence in mental and brain disorders and suggestions for good clinical practice.
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,075 Previous Clinical Trials
42,719,828 Total Patients Enrolled
71 Trials studying Depression
29,995 Patients Enrolled for Depression
Yvette I Sheline, MDPrincipal InvestigatorUniversity of Pennsylvania
2 Previous Clinical Trials
187 Total Patients Enrolled
2 Trials studying Depression
187 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking medication for my mental health or am in therapy.I am between 18 and 65 years old and have been diagnosed with major depressive disorder.I am outside the specified age range for the trial.My thinking and memory skills are normal.I have permanent vision loss that cannot be corrected.My gender does not exclude me from this trial.
Research Study Groups:
This trial has the following groups:- Group 1: Sham Neurofeedback
- Group 2: Active Neurofeedback
Awards:
This trial has 0 awards, including: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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