NCT05703256

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable major-depressive-disorder

Timeline
24mo left

Started Jun 2023

Longer than P75 for not_applicable major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Jun 2023Apr 2028

First Submitted

Initial submission to the registry

January 18, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 30, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2028

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

3.9 years

First QC Date

January 18, 2023

Last Update Submit

March 3, 2026

Conditions

Major Depressive Disorder

Keywords

neurofeedbackamygdaladepressionmajor depressive disorder

Outcome Measures

Primary Outcomes (1)

  • Beck Depression Inventory (BDI-II)

    measures depressive symptoms. The total score will be used, which ranges from 0-63. A total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. Lower values represent better outcomes.

    baseline vs up to one year

Secondary Outcomes (1)

  • Life Functioning Questionnaire (LFQ)

    baseline vs up to one year

Other Outcomes (1)

  • Autobiographical Memory Test

    baseline vs one month

Study Arms (2)

Amygdala real-time fMRI neurofeedback

EXPERIMENTAL

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.

Device: Amygdala real-time fMRI neurofeedback

Sham feedback

SHAM COMPARATOR

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

Device: Sham feedback

Interventions

Amygdala real-time fMRI neurofeedbackDEVICE

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

Amygdala real-time fMRI neurofeedback
Sham feedbackDEVICE

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

Sham feedback

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

RECRUITING

Related Publications (3)

  • Young KD, Zotev V, Phillips R, Misaki M, Yuan H, Drevets WC, Bodurka J. Real-time FMRI neurofeedback training of amygdala activity in patients with major depressive disorder. PLoS One. 2014 Feb 11;9(2):e88785. doi: 10.1371/journal.pone.0088785. eCollection 2014.

    PMID: 24523939BACKGROUND

  • Young KD, Siegle GJ, Zotev V, Phillips R, Misaki M, Yuan H, Drevets WC, Bodurka J. Randomized Clinical Trial of Real-Time fMRI Amygdala Neurofeedback for Major Depressive Disorder: Effects on Symptoms and Autobiographical Memory Recall. Am J Psychiatry. 2017 Aug 1;174(8):748-755. doi: 10.1176/appi.ajp.2017.16060637. Epub 2017 Apr 14.

    PMID: 28407727BACKGROUND

  • Young KD, Misaki M, Harmer CJ, Victor T, Zotev V, Phillips R, Siegle GJ, Drevets WC, Bodurka J. Real-Time Functional Magnetic Resonance Imaging Amygdala Neurofeedback Changes Positive Information Processing in Major Depressive Disorder. Biol Psychiatry. 2017 Oct 15;82(8):578-586. doi: 10.1016/j.biopsych.2017.03.013. Epub 2017 Mar 28.

    PMID: 28476207BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Kymberly Young, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kymberly Young, PhD

CONTACT

412-648-6179youngk@pitt.edu

Lisa Stupar

CONTACT

412-383-8100stuparlm@upmc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to receive amygdala neurofeedback or yoked sham neurofeedback (seeing the amygdala activity of another participant)
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Psychiatry

Study Record Dates

First Submitted

January 18, 2023

First Posted

January 30, 2023

Study Start

June 1, 2023

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2028

Last Updated

March 4, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

All fMRI, BDI and LFQ scores for IPD will be made available through the NDAR data repository

Time Frame
New data will be uploaded every 6 months and be available indefinitely
Access Criteria
Users with NDA credentials may submit Data Access Requests. Data Access Requests for a given NDA Permission Group are reviewed by an NIH-staffed Data Access Committee.
More information

Locations

US(1)