Recruiting

Amygdala Neurofeedback

Sponsor:

Kymberly Young

Code:

NCT05703256

Conditions

Major Depressive Disorder

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Amygdala real-time fMRI neurofeedback

Sham feedback

Study Details

Brief summary:

The goal of this study is to evaluate whether rtfMRI-nf training to increase the amygdala response to positive memories may serve as a stand-alone intervention for major depressive disorder

Conditions

Major Depressive Disorder

Study ID

NCT05703256

Start date

Jun 1, 2023

Status verified date

Mar, 2026

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • ages 18 - 55
  • primary diagnosis of MDD and are currently depressed
  • able to give written informed consent prior to participation
  • unmedicated OR are stable on an antidepressant regime (at least 4 weeks to ensure symptoms are stable). Effective medications will not be discontinued for the purposes of the study.

Exclusion Criteria:

  • clinically significant or unstable cardiovascular, pulmonary, endocrine, neurological, gastrointestinal illness or unstable medical disorder
  • Current severe DSM-V alcohol or substance use disorder, with the exception of nicotine or caffeine. Clinician will access subjects' alcohol and substance use on a case-by-case to determine whether specific cases of mild or moderate alcohol or substance use would also interfere with the effects of the intervention.
  • history of traumatic brain injury
  • unable to complete MRI scan due to claustrophobia or general MRI exclusions (e.g., shrapnel inside body)
  • currently pregnant or breast feeding
  • unable to complete questionnaires written in English
  • current (within 3 weeks of testing) use of any antipsychotics, anticonvulsants, stimulants, benzodiazepines, beta-blockers, or other medications (except antidepressants) likely to influence cerebral blood flow. Effective medications will not be discontinued for the purposes of the study.
  • diagnosis of psychotic or organic mental disorder, bipolar I or II disorder.
  • eye problems or difficulties in corrected vision.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Amygdala real-time fMRI neurofeedback

Amygdala neurofeedback - attempt to upregulate the left amygdala during positive autobiographical memory recall via real time fMRI neurofeedback from the amygdala. Two sessions will be performed one week apart.

sham comparator: Sham feedback

Yoked sham - participants will see the amygdala activity of another subject who completed the intervention. Two sessions will be performed one week apart.

Interventions

Amygdala real-time fMRI neurofeedback

Participants are shown activity from their left amygdala in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories

Sham feedback

Participants are shown activity from another participant's left amygdala who previously completed the task and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories

Primary outcome measure

  • Beck Depression Inventory (BDI-II) [ Time Frame: baseline vs up to one year ]

Central Contacts and Locations

Central contacts

Kymberly Young, PhD

412-648-6179youngk@pitt.edu

Lisa Stupar

412-383-8100stuparlm@upmc.edu

Locations

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15261

Contacts

Kymberly Young, PhD

youngk@pitt.edu

More Information

Sponsor

Kymberly Young

Last update posted

Mar 4, 2026

Last verified

Mar, 2026

Keywords

  • neurofeedback
  • amygdala
  • depression
  • major depressive disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kymberly Young on 2026-03-04.