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Trial record 57 of 129 for:    "Depressive Disorder" [DISEASE] AND Behavioral | ( Map: Spain )

Validating Reward-related Biomarkers (RTOC) (RTOC)

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ClinicalTrials.gov Identifier: NCT04024371
Recruitment Status : Recruiting
First Posted : July 18, 2019
Last Update Posted : October 3, 2019
Sponsor:
Collaborators:
P1vital Products LTD.
BIOTRIAL
University Hospital Frankfurt, Department of Psychiatry, Psychosomatic Medicine and Psychotherapy
The Institute of Neuropsychiatry and Addictions (INAD), Parc de Salut Mar, Barcelona
Aristotle University of Thessaloniki, School of Medicine, Department of Clinical Pharmacology
Maastricht University, School for Mental Health and Neuroscience
Information provided by (Responsible Party):
Maastricht University

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 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).


Condition or disease Intervention/treatment
Schizophrenia Depression Motivation Anhedonia, Physical Anhedonia, Social Negative Symptoms With Primary Psychotic Disorder Behavioral: Self-rating Questionnaires Behavioral: Measures of Reward processing/reinforcement learning Behavioral: Additional Schizophrenia-specific Questionnaires and Interviews

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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Validating Reward-related Biomarkers to Facilitate Development of New Treatments for Anhedonia and Reward Processing Deficits in Schizophrenia and Major Depressive Disorder
Actual Study Start Date : September 16, 2019
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Group/Cohort Intervention/treatment
HV
Humans aged 20-55 without a diagnosis of a psychiatric and neurological disorder.
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)

SZ
Humans aged 20-55 with a primary Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) diagnosis of Schizophrenia.
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)

MDD
Humans aged 20-55 with a primary Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) diagnosis of MDD.
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)




Primary Outcome Measures :
  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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04024371


Contacts
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Contact: Dennis Hernaus, PhD +31 43 388 ext 3893 dennis.hernaus@maastrichtuniversity.nl

Locations
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Germany
University Hospital Frankfurt, Department of Psychiatry, Psychosomatic Medicine and Psychotherap Recruiting
Frankfurt, Germany
Contact: Andreas Reif, MD, PhD         
Greece
Aristotle University of Thessaloniki, School of Medicine, Department of Clinical Pharmacology Recruiting
Thessaloníki, Greece
Contact: Georgios Papazisis, MD PhD         
Netherlands
Maastricht University Recruiting
Maastricht, Netherlands
Contact: Therese van Amelsvoort, MD, PhD         
Spain
Institute of Neuropsychiatry and Addictions (INAD), Parc de Salut Mar, Barcelona Recruiting
Barcelona, Spain
Contact: Victor Pérez Sola, MD PhD         
Sponsors and Collaborators
Maastricht University
P1vital Products LTD.
BIOTRIAL
University Hospital Frankfurt, Department of Psychiatry, Psychosomatic Medicine and Psychotherapy
The Institute of Neuropsychiatry and Addictions (INAD), Parc de Salut Mar, Barcelona
Aristotle University of Thessaloniki, School of Medicine, Department of Clinical Pharmacology
Maastricht University, School for Mental Health and Neuroscience
Investigators
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Study Director: Dennis Hernaus, PhD Maastricht University

Publications of Results:
Other Publications:
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Responsible Party: Maastricht University
ClinicalTrials.gov Identifier: NCT04024371     History of Changes
Other Study ID Numbers: RTOC1
First Posted: July 18, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anhedonia
Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms