NCT04024371

Validating Reward-related Biomarkers (RTOC)

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 160 (actual)
• Sponsor: Maastricht University · Academic / Other
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

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).

Conditions

• Schizophrenia
• Depression
• Motivation
• Anhedonia, Physical
• Anhedonia, Social
• Negative Symptoms With Primary Psychotic Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Self-rating Questionnaires	* Snaith-Hamilton Pleasure Scale (SHAPS; Snaith et al. 1995) * Quick Inventory of Depressive Symptomatology (QIDS; 16 items) * Behavioral avoidance/inhibition Scales (BIS/BAS)
BEHAVIORAL	Measures of Reward processing/reinforcement learning	* Grip Strength Effort Task (Reddy et al. 2015; in combination with EEG) * Doors (Gambling) task (Foti and Hajcak 2009; in combination with EEG) * Reinforcement Learning/Working Memory task (Collins et al. 2017; no EEG)
BEHAVIORAL	Additional Schizophrenia-specific Questionnaires and Interviews	* Positive and Negative Syndrome Scale (PANSS: Kay et al. 1987) * Brief Negative Symptom Scale (BNSS; Kirkpatrick et al. 2011)

Timeline

• Start date: 2019-09-16
• Primary completion: 2021-02-01
• Completion: 2021-02-01
• First posted: 2019-07-18
• Last updated: 2022-07-26

Locations

4 sites across 4 countries: Germany, Greece, Netherlands, Spain