NCT04325529

Pharmaco-Neuroimaging Studies of Approach/Avoidance Behaviors and Post-Mortem Studies: Study 1.2 (Stress Manipulation)

Novel Treatment Targets For Affective Disorders Through Cross-Species Investigation of Approach/Avoidance Decision Making

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 148 (actual)
• Sponsor: Mclean Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study investigates how remitted individuals with past major depressive disorder (MDD) make approach-avoidance decisions and which brain regions are implicated in such decisions. Information collected through MRI and behavioral tasks will be used to predict depressive symptoms in the future.

Detailed description

The overarching goals of this research are to investigate: (1) neural substrates of approach/avoidance behaviors in remitted MDDs; (2) stress-induced signaling in remitted individuals with past MDD; (3) neural markers that prospectively predict disease course. This will be achieved through an innovative method of using functional magnetic resonance imaging (fMRI) during an approach/avoidance decision-making task.

Conditions

• Major Depression in Remission

Interventions

Type	Name	Description
DEVICE	Aversive stimuli	Electrotactile stimulation will be used as the aversive stimulus. The aversive stimulus is delivered in the form of a mild half-second stimulation to the ankle, calibrated to a subjective threshold that is uncomfortable but not painful. This stimulation is delivered by Digitimer DS8R Constant Current Stimulator (Digitimer North America, LLC. Ft. Lauderdale, FL). Its previous model DS71 has been safely implemented in studies with previously MGH-approved IRB's (Milad et al., 2013).

Timeline

• Start date: 2021-01-19
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2020-03-27
• Last updated: 2025-12-12

Locations

1 site across 1 country: United States