What side effects are associated with this type of intervention?

Common treatments for depression include pharmacological options like SSRIs, SNRIs, and atypical antidepressants, which can cause side effects such as nausea, weight gain, sexual dysfunction, insomnia, and dry mouth. Non-pharmacological treatments like cognitive-behavioral therapy (CBT) and neurofeedback therapies, including real-time fMRI neurofeedback therapy, generally have fewer physical side effects but may cause temporary discomfort or emotional distress. Real-time fMRI neurofeedback therapy is non-invasive and well-tolerated, with mild side effects such as headache or fatigue due to extended periods of concentration.

What prior FDA approvals exist?

The FDA has approved several treatments for depression, primarily focusing on pharmacotherapy and neuromodulation techniques. Commonly approved antidepressants include selective serotonin reuptake inhibitors (SSRIs) like fluoxetine and sertraline, serotonin-norepinephrine reuptake inhibitors (SNRIs) like venlafaxine, and atypical antidepressants like bupropion. Neuromodulation techniques such as repetitive transcranial magnetic stimulation (rTMS) and electroconvulsive therapy (ECT) have also received FDA approval. While Real-time fMRI Neurofeedback Therapy is a novel approach focusing on modulating attentional states to reduce negative attention bias, it represents an emerging area of research rather than an established FDA-approved treatment.

What other types of research exist?

Promising novel alternatives to real-time fMRI neurofeedback therapy for depression include: 1) Transcranial Magnetic Stimulation (TMS), which has shown efficacy in reducing depressive symptoms, particularly when applied to the frontal cortex. 2) Transcranial Direct Current Stimulation (tDCS), which has demonstrated potential in reducing both positive and negative symptoms of depression. 3) Cognitive Behavioral Therapy (CBT), especially digital or online CBT, which has been effective in improving psychological well-being and sleep-related quality of life. 4) Electroconvulsive Therapy (ECT), particularly for treatment-resistant depression, which has been shown to be effective in multiple randomized controlled trials.

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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 below

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I am between 18 and 65 years old and have been diagnosed with major depressive disorder.

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My thinking and memory skills are normal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking medication for my mental health or am in therapy.

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I am outside the specified age range for the trial.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

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.

0 / 5Eligibility criteria met

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.