An interventional study of Amygdala real-time fMRI neurofeedback and Sham feedback in Major Depressive Disorder, sponsored by Kymberly Young. Recruiting at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-03-04.
Sponsored by Kymberly Young · Not applicable, Interventional, and Treatment
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
Previous research has shown that real-time fMRI neurofeedback (rtfMRI-nf) training aimed at increasing the amygdala's response to positive autobiographical memory recall holds therapeutic potential for treating patients with major depressive disorder (MDD), as clinically significant decreases in clinician administered and self-report measures of depression severity were observed following two rtfMRI amygdala neurofeedback sessions. Furthermore, rtfMRI amygdala neurofeedback changed emotional processing towards a positive bias. The goal of the current study is to confirm the clinical efficacy of this intervention in a new sample of depressed participants. Thus, over the course of four years, we will conduct a randomized double-blind clinical trial examining the clinical and cognitive effects of amygdala rtfMRI-nf compared to yoked sham rtfMRI-nf (seeing the amygdala activity of another participant during training) in 200 participants with MDD from the Pittsburgh metropolitan area. Participants will undergo two rtfMRI-nf sessions. Half of the participants will receive amygdala neurofeedback and half will receive yoked sham neurofeedback. Participants will complete the BDI-II monthly for one year following completion of the neurofeedback intervention. The rationale for the proposed research is to provide new insights into possible mechanistic solutions for MDD, and to further guide development of this rtfMRI-nf intervention into a treatment for MDD.
2,740 studies on the registry are indexed under Depressive Disorder, Major; 558 are open to participants now.
This study's planned enrollment of 200 is above the median of 80 across 2,282 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →Kymberly Young is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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
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
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
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
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.
Time frame: baseline vs up to one year
Life Functioning Questionnaire (LFQ)
measures ability to function in daily life. The total score will be used, which ranges from 14-56. A total score of 14-27 indicates no problems, and a score of 28+ indicates some impairment. Lower values represent better outcomes.
Time frame: baseline vs up to one year
Autobiographical Memory Test
measures memory specificity. Participants are asked to recall a memory in response to 18 cue words. The number of specific memories is determined and reported. Scores can range from 0-18 and higher scores represent better memory performance.
Time frame: baseline vs one month
Plan to share: Yes — All fMRI, BDI and LFQ scores for IPD will be made available through the NDAR data repository
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