Actively Recruiting

Phase Not Applicable
Age: 18Years - 55Years
All Genders
NCT06050070

Targeting Large-scale Networks in Depression With Real-time Functional Magnetic Resonance Imaging (fMRI) Neurofeedback

Led by University of Michigan · Updated on 2025-10-06

70

Participants Needed

1

Research Sites

128 weeks

Total Duration

On this page

Sponsors

U

University of Michigan

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study is to develop a technique called real time fMRI neurofeedback. This technique uses a regular MRI scanner, except that special software allows the researchers to measure activity in participants brain, using fMRI, and then give information, in the form of a feedback signal, which indicates brain activity in real time, while in the MRI scanner. The larger goal of this study is to develop ways to help people, including those with depression, better regulate brain activity. The researchers think that this may be helpful in managing psychiatric symptoms. This study design has three phases, however, only two phases (phase 2 and 3) are considered to be a clinical trial. Phase 2 (part 2) was registered and is NCT05934604. This is the phase 3 (part 3) for this project and is funded by the National Institutes of Health.

CONDITIONS

Official Title

Targeting Large-scale Networks in Depression With Real-time Functional Magnetic Resonance Imaging (fMRI) Neurofeedback

Who Can Participate

Age: 18Years - 55Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Meets DSM-5 criteria for Major Depressive Disorder, single or recurrent, active or in partial remission
  • Patient Health Questionnaire (PHQ9) score of 6 or higher, with about 50% scoring 10 or higher
  • If on antidepressants, stable dosage for at least 4 weeks
  • No active substance use disorder in the past 6 months
  • No suicidal thoughts with plans or intentions as assessed by Columbia Suicide Severity Rating Scale
  • If woman of child-bearing age, not pregnant or trying to become pregnant
  • Ability to tolerate small, enclosed spaces without anxiety
  • No metals, implants, or metallic substances in or on the body that could interfere with MRI
  • Body size compatible with MRI scanner gantry
  • Ability and willingness to provide informed consent
Not Eligible

You will not qualify if you...

  • Body size not compatible with MRI scanner
  • Diagnosed with bipolar disorder, schizophrenia, other psychosis, obsessive-compulsive disorder, active eating disorder, or post-traumatic stress disorder
  • History of serious neurological illness including seizures or epilepsy
  • Current medical condition that may affect brain function such as liver failure
  • History of closed head injury with loss of consciousness greater than approximately 5 minutes, hospitalization, or neurological complications

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

Loading map...

Research Team

S

Sophia Hovakimian

CONTACT

L

Laura Stchur, MSW

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here