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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial tests a new psychotherapy that uses fMRI neurofeedback to reduce negative attention bias and depression severity in people with MDD.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,003 Previous Clinical Trials
42,881,981 Total Patients Enrolled
69 Trials studying Depression
29,408 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

Active Closed Loop Real Time fMRI Neurofeedback (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05169346 — N/A
Depression Research Study Groups: Sham Neurofeedback, Active Neurofeedback
Depression Clinical Trial 2023: Active Closed Loop Real Time fMRI Neurofeedback Highlights & Side Effects. Trial Name: NCT05169346 — N/A
Active Closed Loop Real Time fMRI Neurofeedback (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05169346 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals currently being accepted to participate in this research?

"Affirmative. According to clinicaltrials.gov, this medical study is actively seeking participants; the trial was initially published on May 25th 2022 and updated last on October 10th of the same year. 140 individuals will be recruited from a single clinic for this experiment."

Answered by AI

Does this experiment accept participants of a certain age, e.g over 60?

"This trial is only available for those between 18 and 65 years old. Conversely, there are 27 trials that accept minors and 213 studies targeting seniors as participants."

Answered by AI

What is the aggregate number of participants in this clinical trial?

"Affirmative. Based on the information available from clinicaltrials.gov, this medical experiment launched in May 25th 2022 and has been edited recently in October 10th is actively recruiting 140 individuals at only one particular centre."

Answered by AI

What are the criteria for entry into this clinical experiment?

"This clinical study is accepting 140 participants that have major depressive disorder and are between 18 to 65 years old."

Answered by AI

Who else is applying?

What site did they apply to?
Center for Neuromodulation in Depression and Stress
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Neurofeedback to Treat Depression
Yvette Sheline 2022. "Neurofeedback to Treat Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05169346.
All > Depression New York
~6 spots leftby Apr 2025
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