Validating Reward-related Biomarkers (RTOC)

Completed

• Conditions: Negative Symptoms With Primary Psychotic Disorder; Anhedonia, Social; Schizophrenia; Depression; Anhedonia, Physical; Motivation
• Interventions: Behavioral: Self-rating Questionnaires; Behavioral: Measures of Reward processing/reinforcement learning; Behavioral: Additional Schizophrenia-specific Questionnaires and Interviews

• Registration Number: NCT04024371
• Lead Sponsor: Maastricht University

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-16
• Study First Submitted QC: 2019-07-17
• Study First Posted: 2019-07-18
• Study Start: 2019-09-16
• Primary Completion: 2021-02-01
• Study Completion: 2021-02-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-25
• Last Update Posted: 2022-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HV	Self-rating Questionnaires	Humans aged 20-55 without a diagnosis of a psychiatric and neurological disorder.
HV	Measures of Reward processing/reinforcement learning	Humans aged 20-55 without a diagnosis of a psychiatric and neurological disorder.
SZ	Measures of Reward processing/reinforcement learning	Humans aged 20-55 with a primary Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) diagnosis of Schizophrenia.
SZ	Additional Schizophrenia-specific Questionnaires and Interviews	Humans aged 20-55 with a primary Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) diagnosis of Schizophrenia.
MDD	Self-rating Questionnaires	Humans aged 20-55 with a primary Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) diagnosis of MDD.
SZ	Self-rating Questionnaires	Humans aged 20-55 with a primary Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) diagnosis of Schizophrenia.
MDD	Measures of Reward processing/reinforcement learning	Humans aged 20-55 with a primary Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) diagnosis of MDD.

Primary Outcome Measures

Name	Time	Method
Doors task outcome	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	Day 1	Percentage of hard task choices at different reward levels
RL/WM task outcome	Day 1	Accuracy as function of set size (difficulty)

Trial Locations

Locations (4)

University Hospital Frankfurt, Department of Psychiatry, Psychosomatic Medicine and Psychotherap; 🇩🇪 Frankfurt, Germany

Institute of Neuropsychiatry and Addictions (INAD), Parc de Salut Mar, Barcelona; 🇪🇸 Barcelona, Spain

Aristotle University of Thessaloniki, School of Medicine, Department of Clinical Pharmacology; 🇬🇷 Thessaloníki, Greece

Maastricht University; 🇳🇱 Maastricht, Netherlands