Validating Reward-related Biomarkers (RTOC)

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

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)

Sponsors & Collaborators

• P1vital Products LTD.

  collaborator UNKNOWN

• Biotrial

  collaborator INDUSTRY

• University Hospital Frankfurt, Department of Psychiatry, Psychosomatic Medicine and Psychotherapy

  collaborator UNKNOWN

• The Institute of Neuropsychiatry and Addictions (INAD), Parc de Salut Mar, Barcelona

  collaborator UNKNOWN

• Aristotle University Of Thessaloniki

  collaborator OTHER

• Maastricht University, School for Mental Health and Neuroscience

  collaborator UNKNOWN

• Maastricht University

  lead OTHER

Principal Investigators

• Dennis Hernaus, PhD · Maastricht University

Eligibility

Min Age

20 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-09-16

Primary Completion

2021-02-01

Completion

2021-02-01

Countries

• Germany
• Greece
• Netherlands
• Spain

Study Locations