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NCT04024371: RTOC

Validating Reward-related Biomarkers (RTOC)

Completed Last updated 26 July 2022
What this trial tests

trial testing Self-rating Questionnaires in Schizophrenia in 160 participants. Completed in 1 February 2021.

Timeline
16 September 2019
Primary endpoint
1 February 2021
1 February 2021

Quick facts

Lead sponsorMaastricht University
StatusCompleted
Study typeOBSERVATIONAL
Enrollment160
Start date16 September 2019
Primary completion1 February 2021
Estimated completion1 February 2021
Sites4 locations across Netherlands, Greece, Germany, Spain

Drugs / interventions tested

Conditions studied

Sponsor

Maastricht University

Who can join

Adults 20 to 55, any sex, with Schizophrenia or Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Optimizing Behavioral Paradigms to Facilitate Development of New Treatments for Anhedonia and Reward Processing Deficits in Schizophrenia and Major Depressive Disorder: Study Protocol.
    Bilderbeck AC, Raslescu A, Hernaus D, Hayen A, et al · · 2020 · cited 6× · PMID 33250788 · DOI 10.3389/fpsyt.2020.536112

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Other recruiting trials for Schizophrenia

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