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

Active, not recruiting

• Conditions: Major Depression in Remission
• Interventions: Device: Aversive stimuli

• Registration Number: NCT04325529
• Lead Sponsor: Mclean Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2020-03-24
• Study First Submitted QC: 2020-03-26
• Study First Posted: 2020-03-27
• Study Start: 2021-01-19
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-13
• Primary Completion: 2025-03-31
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control subjects	Aversive stimuli	healthy control subjects
remitted MDD	Aversive stimuli	Unmedicated Remitted Participants with Past History of MDD

Primary Outcome Measures

Name	Time	Method
Clinical Interview	Baseline	For assessing psychological state
Salivary Cortisol	Baseline	For assessing stress level
MRI Data	MRI scans take place within 30 days of Screening Visit	For testing the neural correlates of approach-avoidance decision making behaviors in a trans-diagnostic sample
Follow-up Clinical interviews	Change from Baseline at 6 months and 12 months after the MRI scanning visit	To assess psychological state changes
Behavioral Performance on the Probabilistic Reward Task (PRT)	Baseline	The Probablilistic Reward Task assesses positive reinforcement learning.

Trial Locations

Locations (1)

McLean Hospital; 🇺🇸 Belmont, Massachusetts, United States