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Clinical Trials/NCT04024371
NCT04024371
Completed
Not Applicable

Validating Reward-related Biomarkers to Facilitate Development of New Treatments for Anhedonia and Reward Processing Deficits in Schizophrenia and Major Depressive Disorder

Maastricht University4 sites in 4 countries160 target enrollmentSeptember 16, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
Maastricht University
Enrollment
160
Locations
4
Primary Endpoint
Doors task outcome
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Deficits or abnormalities in reward processing are present in a number of psychiatric disorders. The overarching objective of the study is to conduct initial validation work towards optimising three experimental tasks - which have previously been shown to be sensitive to reward processing deficits - for future use in clinical trials.

This initial validation work has the primary objective to uncover group differences in task outcome measures between healthy control participants, participants with Major Depressive Disorder (MDD) and participants with schizophrenia (SZ) using statistical analyses. This may provide some indications for the use of these tasks as clinically-relevant biomarkers.

Primary aims include:

(i) comparing the investigator's endpoint means and distributions to those in previously published data; (ii) replication of previously-reported differences between MDD/SZ vs. healthy control participants, and, (iii) exploring the relationship between task endpoints and subjective participant- and clinician-rated report of reward-related constructs (e.g. anhedonia, negative symptoms).

Registry
clinicaltrials.gov
Start Date
September 16, 2019
End Date
February 1, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Doors task outcome

Time Frame: Day 1

"Feedback negativity", an event-related potential (ERP) at approximately 300ms after feedback presentation indicating a favourable versus unfavourable outcome in paradigms in which the participant loses or wins money.

Grip effort outcome

Time Frame: Day 1

Percentage of hard task choices at different reward levels

RL/WM task outcome

Time Frame: Day 1

Accuracy as function of set size (difficulty)

Study Sites (4)

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