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Behavioral Intervention

Neurofeedback for Depression (CNF-RNT Trial)

N/A
Recruiting
Research Sponsored by Laureate Institute for Brain Research, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Young adults ages 18-35
Meeting DSM-5 diagnostic criteria for MDD who are currently depressed defined by the MINI
Must not have
Schizophrenia or schizoaffective disorder
Current diagnosis of post-traumatic disorder (PTSD) defined by the MINI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up a week later

Summary

This trial aims to investigate the relationship between brain connectivity and repetitive negative thinking in individuals with depression. The researchers will use a technique called real-time fMRI neurofeedback to reduce the connectivity between certain brain regions

Who is the study for?
This trial is for young adults with major depressive disorder (MDD) who often have repetitive negative thoughts. Participants must be within a certain age range, typically considered 'young adult', and should meet specific criteria for MDD and high levels of such thoughts.
What is being tested?
The study tests if real-time fMRI neurofeedback can influence brain networks to reduce repetitive negative thinking in depression. It's a randomized trial comparing active neurofeedback targeting specific brain areas versus sham (fake) feedback.
What are the potential side effects?
Since the intervention involves non-invasive brain imaging and feedback, side effects may include discomfort from lying still during MRI scans or possible frustration if no improvement in symptoms is perceived.

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 35 years old.
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I have been diagnosed with major depression according to DSM-5.
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I often find myself dwelling on my problems.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with schizophrenia or schizoaffective disorder.
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I have been diagnosed with PTSD.
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I am currently taking more than three medications for mental health issues.
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I am fluent in English.
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I do not have any serious or unstable health conditions.
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I have had a severe brain injury or a disorder affecting my brain function.
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I am currently taking heart medications that affect blood vessel behavior.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~a week later
This trial's timeline: 3 weeks for screening, Varies for treatment, and a week later for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Changes in Brief State Rumination Inventory (BSRI)
Changes in Montgomery-Åsberg Depression Rating Scale (MADRS)
Other study objectives
Functional connectivity change between right anterior insular (rAI) and right superior temporal sulcus (rSTS)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active neurofeedbackExperimental Treatment1 Intervention
Receiving feedback signals from the repetitive negative thinking (RNT)-related brain functional connectivity
Group II: Sham neurofeedbackPlacebo Group1 Intervention
Receiving artificially generated feedback signals.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Active neurofeedback
2021
N/A
~50

Find a Location

Who is running the clinical trial?

Laureate Institute for Brain Research, Inc.Lead Sponsor
52 Previous Clinical Trials
5,330 Total Patients Enrolled
National Institute of General Medical Sciences (NIGMS)NIH
294 Previous Clinical Trials
248,875 Total Patients Enrolled
~73 spots leftby Jul 2026
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