MDD Clinical Trial - Neurofeedback to Treat Depression

Status Recruiting

Clinical Trial Summary

This study tests the efficacy of a new psychotherapeutic strategy for reducing negative attention bias (and therefore depression severity) in participants with MDD (60 in R61 phase and 80 in R33 Phase). This real-time fMRI neurofeedback therapy uses cloud-based pattern classification to decode a patient's attentional state and dynamically modulate task stimuli (in a closed loop) based on this state.

Clinical Trial Description

In both the R61and R33 phases we will compare cloud based real time fMRI feedback with placebo (sham feedback) in reducing negative attention bias and depressive symptoms. This study will be the first dose-finding test of real-time fMRI effect on negative attention bias. Measures include: Structured Clinical Interview for DSM-5 (SCID), Clinician-administered diagnostic exam, Montgomery Asberg Depression Rating Scale (MADRS), Clinician-administered scale used to assess the severity of depression, State-Trait Anxiety Inventory (STAI), Self-report questionnaire used to measure types of anxiety and mood symptoms, Mood and Anxiety Symptom Questionnaire (MASQ), Negative perseveration during a go/no-go task, Go/no-go task with overlaid face/scene stimuli; brain response triggers next stimulus, Negative gaze, Negative gaze collected in gaze data following each real time fMRI feedback session ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05169346
Study type	Interventional
Source	University of Pennsylvania
Contact	Frederick Nitchie
Phone	(215) 573-9058
Email	frederick.nitchie@pennmedicine.upenn.edu
Status	Recruiting
Phase	N/A
Start date	May 25, 2022
Completion date	December 31, 2024

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