Neurofeedback for Treatment Resistant Depression

NCT03428828 | Completed DMC FDA Device

• 2 other identifiers: STUDY19020313R61MH115927
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the clinical efficacy of real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) training to increase the amygdala's response to positive autobiographical memories in patients with depression who are considered treatment-resistant

Conditions

Treatment Resistant Depression

Keywords

Neurofeedback; major depressive disorder; treatment resistant; amygdala

Outcome Measures

Primary Outcomes (1)

• Beck Depression Inventory (BDI-II)

  12 weeks

Secondary Outcomes (1)

• Amygdala Activity

  8 weeks

Study Arms (2)

Amygdala Neurofeedback

EXPERIMENTAL

attempt to up regulate the left amygdala during positive autobiographical memory recall via real time fMRI neurofeedback from the amygdala. Five sessions will be performed within a 2 month period.

Device: Amygdala Neurofeedback

Parietal Neurofeedback

ACTIVE COMPARATOR

attempt to upregulate the left horizontal segment of the intraparietal sulcus, a region not involved in emotional processing, during positive autobiographical memory recall via real time fMRI neurofeedback. Five sessions will be performed within a 2 month period.

Device: Parietal Neurofeedback

Interventions

Amygdala Neurofeedback DEVICE

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 Neurofeedback

Parietal Neurofeedback DEVICE

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

Parietal Neurofeedback

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• right-handed adults (ages 18 - 55) with a primary diagnosis of MDD according to diagnostic criteria DSM-5 for recurrent MDD who are currently depressed will be recruited to participate
• must be able to give written informed consent prior to participation
• must have fewer than 45% memories categorized as specific on the Autobiographical Memory Test
• must have a SHAPS score \> 4, indicating the presence of anhedonia
• unmedicated or stable on an SSRI antidepressant regime (at least 3 weeks to ensure symptoms are stable)
• previously failed to respond to two previous SSRI medications according to either a medical record review or clinical interview during Visit 1

You may not qualify if:

• have a clinically significant or unstable cardiovascular, pulmonary, endocrine, neurological, gastrointestinal illness or unstable medical disorder
• met DSM-IV criteria for alcohol and/or substance dependence (other than nicotine) within 12 months prior to screening
• have a history of traumatic brain injury
• are currently pregnant or breast feeding
• are unable to complete questionnaires written in English
• have a DSM-5 diagnosis of psychotic or organic mental disorder, bipolar I or II disorder or any past or current manic or hypomanic symptoms, autism, or a primary diagnosis of an anxiety disorder (though co-morbid anxiety will not be excluded)
• have any eye problems or difficulties in corrected vision.

Sponsors & Collaborators

• Kymberly Young: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

Related Publications (2)

• 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: 28407727 BACKGROUND

• Compere L, Siegle GJ, Lazzaro S, Riley E, Strege M, Canovali G, Barb S, Huppert T, Young K. Amygdala real-time fMRI neurofeedback upregulation in treatment resistant depression: Proof of concept and dose determination. Behav Res Ther. 2024 May;176:104523. doi: 10.1016/j.brat.2024.104523. Epub 2024 Mar 15.

  PMID: 38513424 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Kymberly Young, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: February 12, 2018
• Study Start: October 22, 2018
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

US (1)