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SchizophreniaRTOCNCT04024371

Validating Reward-related Biomarkers (RTOC)

An observational study of Schizophrenia and Depression, run by Maastricht University at 4 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Schizophrenia, Depression, Motivation
What is being tested?
Self-rating Questionnaires, Measures of Reward processing/reinforcement learning and Additional Schizophrenia-specific Questionnaires and Interviews
How many people
160 participants
Where
4 sitesin 4 countries
Study dates
16 Sep 2019to 1 Feb 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: A sample of 37 completed individuals with MDD, 37 completed individuals with SZ, and a maximum of 80 healthy volunteers (without a neurological or psychiatric disorder) who will not differ on age or gender.

General:

  1. Be able to provide signed and dated informed consent for study participation.
  2. Be male or female, aged between 20 and 55 years, inclusive.
  3. Be able to read, write, and speak the language in which psychometric tests are provided, with acceptable visual and auditory acuity (corrected if necessary).
  4. 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:

  1. 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.
  2. Meet the DSM-5 criteria for a current Major Depressive Episode, with the current depressive episode not having lasted longer than 6 months.
  3. 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:

  1. 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.
  2. Dose of antipsychotics not exceeding the equivalent of 6 mg risperidone.

Trial locations and contacts

4 sites in 4 countries.

4 sites in 4 countries

Germany1 site

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

    Frankfurt

Other trials in Germany

Greece1 site

  • Aristotle University of Thessaloniki, School of Medicine, Department of Clinical Pharmacology

    Thessaloniki

Other trials in Greece

Netherlands1 site

  • Maastricht University

    Maastricht

Other trials in Netherlands

Spain1 site

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

    Barcelona

Other trials in Spain

About this study

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

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.

Read more

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).

Being tested
Self-rating Questionnaires, Measures of Reward processing/reinforcement learning, Additional Schizophrenia-specific Questionnaires and Interviews
Medical subject headings
Schizophrenia, Depression, Anhedonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self-rating QuestionnairesBehavioural

    • 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 learningBehavioural

    • 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 InterviewsBehavioural

    • Positive and Negative Syndrome Scale (PANSS: Kay et al. 1987)
    • Brief Negative Symptom Scale (BNSS; Kirkpatrick et al. 2011)
Study groups in NCT04024371
Study groupRoleWhat they receive
HVHumans aged 20-55 without a diagnosis of a psychiatric and neurological disorder.
Receives: Behavioral: Self-rating Questionnaires; Behavioral: Measures of Reward processing/reinforcement learning
SZHumans aged 20-55 with a primary Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) diagnosis of Schizophrenia.
Receives: Behavioral: Self-rating Questionnaires; Behavioral: Measures of Reward processing/reinforcement learning; Behavioral: Additional Schizophrenia-specific Questionnaires and Interviews
MDDHumans aged 20-55 with a primary Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) diagnosis of MDD.
Receives: Behavioral: Self-rating Questionnaires; Behavioral: Measures of Reward processing/reinforcement learning

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Grip effort outcome

    Percentage of hard task choices at different reward levels

    Measured: Day 1

  2. Doors task outcome

    "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.

    Measured: Day 1

  3. RL/WM task outcome

    Accuracy as function of set size (difficulty)

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2019
  2. Study start16 Sep 2019
  3. Primary completion1 Feb 2021
  4. Study completion1 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04024371
Sponsor's protocol ID
RTOC1
Acronym
RTOC
Status last verified
Jul 2022
First submitted
16 Jul 2019
Last updated
26 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The RTOC clinical study has received funding from Boehringer Ingelheim International GmbH, H. Lundbeck, Janssen Pharmaceutica, Blackthorn Therapeutics, and F. Hoffmann-La Roche Ltd. All individual data will be made available to these parties.

Publications

  • Foti D, Hajcak G. Depression and reduced sensitivity to non-rewards versus rewards: Evidence from event-related potentials. Biol Psychol. 2009 Apr;81(1):1-8. doi: 10.1016/j.biopsycho.2008.12.004. Epub 2008 Dec 31.

    PubMed 19162124

  • Collins AGE, Albrecht MA, Waltz JA, Gold JM, Frank MJ. Interactions Among Working Memory, Reinforcement Learning, and Effort in Value-Based Choice: A New Paradigm and Selective Deficits in Schizophrenia. Biol Psychiatry. 2017 Sep 15;82(6):431-439. doi: 10.1016/j.biopsych.2017.05.017. Epub 2017 May 31.

    PubMed 28651789

  • Reddy LF, Horan WP, Barch DM, Buchanan RW, Dunayevich E, Gold JM, Lyons N, Marder SR, Treadway MT, Wynn JK, Young JW, Green MF. Effort-Based Decision-Making Paradigms for Clinical Trials in Schizophrenia: Part 1-Psychometric Characteristics of 5 Paradigms. Schizophr Bull. 2015 Sep;41(5):1045-54. doi: 10.1093/schbul/sbv089. Epub 2015 Jul 3.

    PubMed 26142081

  • Bilderbeck AC, Raslescu A, Hernaus D, Hayen A, Umbricht D, Pemberton D, Tiller J, Sogaard B, Sambeth A, van Amelsvoort T, Reif A, Papazisis G, Perez V, Elices M, Maurice D, Bertaina-Anglade V, Dawson GR, Pollentier S. Optimizing Behavioral Paradigms to Facilitate Development of New Treatments for Anhedonia and Reward Processing Deficits in Schizophrenia and Major Depressive Disorder: Study Protocol. Front Psychiatry. 2020 Nov 5;11:536112. doi: 10.3389/fpsyt.2020.536112. eCollection 2020.

    PubMed 33250788

Questions about this trial

What is this clinical trial studying?

An observational study of Schizophrenia and Depression, run by Maastricht University at 4 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany, Greece, Netherlands, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Grip effort outcome (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04024371, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.

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Validating Reward-related Biomarkers (RTOC) | AzTrials