Suspended

CNF-RNTModulating Repetitive Negative Thinking Related Brain Networks in Young Adults With Depression

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What is being tested

Active neurofeedback

+ Sham neurofeedback

Behavioral
Who is being recruted

Mental Disorders+1

+ Depressive Disorder, Major

+ Depressive Disorder

From 18 to 35 Years
+22 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Placebo-Controlled
Interventional
Study Start: January 2024
See protocol details

Summary

Principal SponsorLaureate Institute for Brain Research, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 12, 2024

Actual date on which the first participant was enrolled.

This study focuses on young adults aged 18 to 25 who suffer from major depressive disorder (MDD). One in ten young adults are affected by MDD, which can lead to serious consequences like related mental disorders, unemployment, and even suicide. The study aims to explore a new approach to treatment by targeting repetitive negative thinking (RNT), a common issue in MDD where individuals struggle to control distressing thoughts. Current treatments such as medication and therapy often have limited success, particularly for those with high levels of RNT. By using real-time functional Magnetic Resonance Imaging neurofeedback (rtfMRI-nf), the study seeks to understand and potentially modify the brain activity associated with these distressing thought patterns, which could lead to better recovery outcomes for those with MDD. Participants in this study will undergo a non-invasive brain imaging technique that provides real-time feedback on their brain activity. The study involves 110 young adults with MDD and high levels of RNT, who will be randomly assigned to receive either real feedback on their brain activity or sham feedback that does not relate to their brain activity. This will be done during a self-regulation task across two visits one week apart. The primary goal is to see if the real feedback can reduce abnormal brain connectivity linked to RNT, potentially decreasing the severity of negative thinking and depression. The study will measure changes in brain connectivity and evaluate the impact on depression and negative thinking severity using established rating scales.

Official TitleModulating Repetitive Negative Thinking Related Brain Networks in Young Adults With Depression
NCT06219681
Principal SponsorLaureate Institute for Brain Research, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

54 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 35 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersDepressive Disorder, MajorDepressive DisorderMood Disorders

Criteria

4 inclusion criteria required to participate
Young adults ages 18-35

Participants who are able to give written informed consent prior to participation

Meeting DSM-5 diagnostic criteria for MDD who are currently depressed defined by the MINI

Participants who have RNT symptoms (Brooding subscale of Ruminative Response Scale: RRS-B ≥ 13)

18 exclusion criteria prevent from participating
Moderate to severe traumatic brain injury (>30 min. loss of consciousness or >24 hours posttraumatic amnesia) or other neurocognitive disorder with evidence of neurological deficits

Presence of co-morbid medical conditions not limited to but including cardiovascular (e.g., history of acute coronary event, stroke), pulmonary, endocrine, neurological diseases (e.g., Parkinson's disease), or gastrointestinal illness, as well as pain disorders

Current significant suicidal ideation or suicide attempt within the previous 12 months

Current psychosis

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Receiving feedback signals from the repetitive negative thinking (RNT)-related brain functional connectivity

Group II

Sham
Receiving artificially generated feedback signals.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Laureate Institute for Brain Research

Tulsa, United StatesOpen Laureate Institute for Brain Research in Google Maps
SuspendedOne Study Center
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