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Behavioral Intervention

Active neurofeedback for Major Depressive Disorder (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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up a week later

Awards & highlights

CNF-RNT Trial 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.Check my eligibility

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.See study design

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.

CNF-RNT Trial 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.

CNF-RNT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately after intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately after intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after intervention for reporting.

Treatment Details

Study Objectives

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

Secondary outcome measures

Changes in Brief State Rumination Inventory (BSRI)

Changes in Montgomery-Åsberg Depression Rating Scale (MADRS)

Other outcome measures

Functional connectivity change between right anterior insular (rAI) and right superior temporal sulcus (rSTS)

CNF-RNT 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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Laureate Institute for Brain Research, Inc.Lead Sponsor

50 Previous Clinical Trials

5,235 Total Patients Enrolled

National Institute of General Medical Sciences (NIGMS)NIH

269 Previous Clinical Trials

247,002 Total Patients Enrolled

Frequently Asked Questions

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

Are individuals currently able to enroll in this ongoing medical study?

"Indeed, according to the information available on clinicaltrials.gov, this research study is actively seeking eligible individuals. The initial posting date was January 12th, 2024 and it has been recently updated on the same day. The trial aims to recruit a total of 110 participants from a single designated site."

Answered by AI

Do I meet the criteria to participate in this medical study?

"To be eligible for participation in this clinical trial, individuals must have a diagnosis of major depressive disorder and fall between the ages of 18 and 35. The study is enrolling a total of 110 participants."

Answered by AI

What is the current number of participants being enrolled in this clinical research study?

"Indeed, the information available on clinicaltrials.gov confirms that this trial is currently seeking individuals to participate. Originally posted on January 12, 2024, it was most recently updated on the same day. The study aims to enroll a total of 110 participants from one site."

Answered by AI