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NCT Number: NCT04024371

Validating Reward-related Biomarkers (RTOC)

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).

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Key information

Conditions

Schizophrenia Anhedonia Anhedonia, Physical Anhedonia, Social Behavior Behavioral Symptoms Depression Mental Disorders Motivation Negative Symptoms With Primary Psychotic Disorder Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

General:

  • Be able to provide signed and dated informed consent for study participation.
  • Be male or female, aged between 20 and 55 years, inclusive.
  • Be able to read, write, and speak the language in which psychometric tests are provided, with acceptable visual and auditory acuity (corrected if necessary).
  • Unless otherwise stated, CNS medications to treat symptoms of MDD or SZ and other stable CNS conditions requiring medication is permitted in the MDD and SZ groups, provided the daily dose of medication has not been changed by more than +/- 30% in the last 4 weeks before the start of the study, and is not expected to change by a larger fraction while participating in the study.

MDD

Participants must:

  • Have a primary Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) diagnosis of MDD, confirmed by the result of the MINI interview conducted by the site at screening. Subjects with a diagnosis of comorbid Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), Panic Disorder or specific phobia may be included.
  • Meet the DSM-5 criteria for a current Major Depressive Episode, with the current depressive episode not having lasted longer than 6 months.
  • If undergoing treatment, be currently treated with an antidepressant approved in this protocol for at least 4 continuous weeks. Psychological treatments (e.g., Cognitive Behaviour Therapy, Interpersonal Psychotherapy, Psychodynamic Psychotherapy etc.) are all permitted in this study regardless of frequency and duration.

SZ

Subjects must:

  • Have a primary diagnosis of schizophrenia according to the Statistical Manual of Mental Disorders 5th edition (DSM-5), confirmed by the result of the MINI interview conducted by the site at screening. Subjects with a diagnosis of comorbid Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), Panic Disorder or specific phobia may be included.
  • Dose of antipsychotics not exceeding the equivalent of 6 mg risperidone.

Treatment and study plan

Self-rating Questionnaires

Behavioral
  • Snaith-Hamilton Pleasure Scale (SHAPS; Snaith et al. 1995)
  • Quick Inventory of Depressive Symptomatology (QIDS; 16 items)
  • Behavioral avoidance/inhibition Scales (BIS/BAS)

Measures of Reward processing/reinforcement learning

Behavioral
  • 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)

Additional Schizophrenia-specific Questionnaires and Interviews

Behavioral
  • Positive and Negative Syndrome Scale (PANSS: Kay et al. 1987)
  • Brief Negative Symptom Scale (BNSS; Kirkpatrick et al. 2011)

Primary outcomes

  1. Grip effort outcome

    Time frame: Day 1

    Percentage of hard task choices at different reward levels

  2. 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.

  3. RL/WM task outcome

    Time frame: Day 1

    Accuracy as function of set size (difficulty)

Sponsors and collaborators

Lead sponsor

Maastricht University

Other

Collaborators

  • Aristotle University Of Thessaloniki
  • Biotrial
  • Maastricht University, School for Mental Health and Neuroscience
  • P1vital Products LTD.
  • The Institute of Neuropsychiatry and Addictions (INAD), Parc de Salut Mar, Barcelona
  • University Hospital Frankfurt, Department of Psychiatry, Psychosomatic Medicine and Psychotherapy

Registry information

Official study title

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

Acronym: RTOC

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 18, 2019
Registry last updated
Jul 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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