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Status:

COMPLETED

Validating Reward-related Biomarkers (RTOC)

Lead Sponsor:

Maastricht University

Collaborating Sponsors:

P1vital Products LTD.

Biotrial

Conditions:

Schizophrenia

Depression

Eligibility:

All Genders

20-55 years

Brief 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 e...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    September 16 2019

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    February 1 2021

    Estimated Enrollment :

    160 Patients enrolled

    Trial Details

    Trial ID

    NCT04024371

    Start Date

    September 16 2019

    End Date

    February 1 2021

    Last Update

    July 26 2022

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

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

    Frankfurt, Germany

    2

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

    Thessaloniki, Greece

    3

    Maastricht University

    Maastricht, Netherlands

    4

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

    Barcelona, Spain