TerminatedNot Applicable

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

Stopped: Terminated due to PI resignation. Not related to safety, efficacy, or administrative mandate.

United States54 participantsStarted 2024-01-12

Plain-language summary

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.

Who can participate

Age range

18 Years – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) Exclusion Criteria: * 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 antiang…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial was terminated before completing — do you know why it was stopped early, and does that affect whether its findings are reliable enough to inform my treatment?
2The trial was focused on changing how specific brain regions involved in repetitive negative thinking communicate with each other — is that kind of brain network approach something being explored in any other active studies that might be relevant for my depression?
3Since this trial targeted young adults with major depressive disorder and focused on reducing repetitive negative thinking, do you think that aspect of my symptoms is significant enough to factor into which treatment we choose?
4This study was listed as Phase NA, which I understand often means it was more exploratory than a standard drug trial — what does that mean for how much we can trust any results that may have come out of it?
5Given that this trial has been terminated, would you recommend we focus on established treatments for my depression right now, or are there similar ongoing studies you think might be worth considering alongside standard care?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Functional Connectivity Change Between Right Anterior Insular (rAI) and Right Superior Temporal Sulcus (rSTS) Within Visit1

Timeframe: Immediately post-intervention during Visit 1 (day 1)

Trial details

NCT IDNCT06219681

SponsorLaureate Institute for Brain Research, Inc.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-04

Results submitted2026-04-28

View on ClinicalTrials.gov More Depressive Disorder, Major trials