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Clinical Trials/NCT04325529
NCT04325529
Active, not recruiting
Not Applicable

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

Mclean Hospital1 site in 1 country148 target enrollmentJanuary 19, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Major Depression in Remission
Sponsor
Mclean Hospital
Enrollment
148
Locations
1
Primary Endpoint
Clinical Interview
Status
Active, not recruiting
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 19, 2021
End Date
June 30, 2026
Last Updated
4 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Diego Pizzagalli

Principal Investigator; Professor, Department of Psychiatry, Harvard Medical School, Mclean Hospital

Mclean Hospital

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Clinical Interview

Time Frame: Baseline

For assessing psychological state

Salivary Cortisol

Time Frame: Baseline

For assessing stress level

MRI Data

Time Frame: 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

Time Frame: 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)

Time Frame: Baseline

The Probablilistic Reward Task assesses positive reinforcement learning.

Study Sites (1)

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