Modulating Repetitive Negative Thinking Related Brain Networks in Young Adults With Depression

Stopped early · Not applicable · Has a placebo group

Conditions studied: Depressive Disorder, Major

In brief

In this project, the investigators use real-time fMRI neurofeedback (rtfMRI-nf) to causally relate dysfunction of right anterior insula (rAI) and right superior temporal sulcus (rSTS) connectivity with the intensity of repetitive negative thinking (RNT). The investigators hypothesize that rtfMRI-nf reducing rAI-rSTS connectivity would reduce RNT. The investigators propose a randomized double-blind, sham-controlled trial of rtfMRI-nf with 110 young adults (n=55/arm) with major depressive disorder (MDD) and high trait-RNT levels.

Key facts

Study ID

NCT06219681

Run by

Laureate Institute for Brain Research, Inc.

People needed

54

Starts

2024-01-12

Expected to finish

2025-04-04

Last updated by the study team

2026-06-17

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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
• Schizophrenia or schizoaffective disorder
• Substance use disorder within the previous 12 months, except for mild alcohol, cannabis, or tobacco use disorder defined as less than 4 symptoms of the criteria for substance use disorder according to the MINI
• Current diagnosis of post-traumatic disorder (PTSD) defined by the MINI
• Severe claustrophobia
• Bodily implants of unsafe paramagnetic materials such as pacemakers and aneurysm clips
• Pregnancy
• Current regular use of cardiovascular medications with a direct vasomotor effect, namely beta- or alpha-beta-blockers, clonidine, and antianginal agents.
• Current use of more than three psychotropic medications
• Evidence of recreational drug use from a urine test
• Commencement of psychotropic medication for depression and/or anxiety less than a month before the study enrollment
• Commencement of psychological therapy less than a month before the study enrollment
• Participants who have a clinically significant or unstable cardiovascular, pulmonary, endocrine, neurological, gastrointestinal illness or unstable medical disorder will be excluded
• Participants who, on arrival to the study, have a temperature greater than 100.4°F will not be allowed to initiate the study
• The majority of the assessments proposed for this study have not been translated from English, thus, non-English speaking volunteers will be excluded

Where it is running

• Laureate Institute for Brain Research — Tulsa, Oklahoma, United States

Full record on ClinicalTrials.gov

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