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Emotion and Motivation in Patients With Psychosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02853019
Recruitment Status : Recruiting
First Posted : August 2, 2016
Last Update Posted : August 20, 2019
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Brief Summary:
Anhedonia and avolition reflect emotional and motivational disorders, respectively. However, if these disorders play a major role in the symptomatology of schizophrenia, their mechanisms remain poorly understood, and existing treatments are inefficient on these symptoms. The literature suggests that the impairment does not concern emotion or motivation per se, but rather their influence on cognition. This project aims at using recent advances in the fundamental domain to better understand the cognitive and neuronal mechanisms of the patients' alterations, and especially how emotion and motivation influence cognition in schizophrenia.

Condition or disease Intervention/treatment Phase
Schizophrenia Other: Electroencephalogram Behavioral: Cognitive tasks Behavioral: subjective evaluation scales Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Influence of Emotion and Motivation on Behaviour and Neural Activity in Patients With Psychosis
Actual Study Start Date : February 2, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Healthy volunteers
Healthy volunteers
Other: Electroencephalogram
electrophysiological measurements (evoked potentials) based on neural activity when visualizing stimuli

Behavioral: Cognitive tasks
- clinical scales and subjective assessments of emotional and motivational stimuli

Behavioral: subjective evaluation scales
- clinical scales and subjective assessments of emotional and motivational stimuli

Experimental: Patients with schizophrenia
Patients with schizophrenia
Other: Electroencephalogram
electrophysiological measurements (evoked potentials) based on neural activity when visualizing stimuli

Behavioral: Cognitive tasks
- clinical scales and subjective assessments of emotional and motivational stimuli

Behavioral: subjective evaluation scales
- clinical scales and subjective assessments of emotional and motivational stimuli




Primary Outcome Measures :
  1. Change in the amplitude of the CNV (Contingent Negative Variation) as a function of the primer displayed on the screen [ Time Frame: During EEG sessions, at experimental session 1 (Day 0) and experimental session 2 (up to Day 120) ]
    Before each cognitive trial a primer will be displayed, which will be either neutral or convey emotion or motivation. The investigators will check whether this primer affects the subjects preparation by measuring the CNV, which is an evoked potential recorded with electroencephalography, and indexing preparatory effort.


Secondary Outcome Measures :
  1. Change in the amplitude of the LPP (Late Positive Potential) as a function of the primer displayed on the screen [ Time Frame: During EEG sessions, at experimental session 1 (Day 0) and experimental session 2 (up to Day 120) ]
    The investigators will check whether primers affect the subjects attention by measuring the LPP, which is an evoked potential recorded with electroencephalography, and indexing sustained attention.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • diagnostic and Statistical Manual of Mental Disorders criteria for schizophrenia

Exclusion Criteria:

  • addiction problem
  • invalidating visual sensory problems
  • neurological history
  • for the healthy volunteers: psychiatric history

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): NCT02853019


Contacts
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Contact: Anne GIERSCH 03 88 11 64 71 giersch@unistra.fr

Locations
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France
Unité INSERM 1114 Recruiting
Strasbourg, France, 67091
Contact: Anne GIERSCH, MD, PhD    03 88 11 64 71    giersch@unistra.fr   
Sub-Investigator: Pierre VIDAILHET, MD, PhD         
Principal Investigator: Anne GIERSCH, MD, PhD         
Sub-Investigator: Fabrice BERNA, MD, PhD         
Sub-Investigator: Laurence LALANNE, MD, PhD         
Sub-Investigator: Sébastien WEIBEL, MD, PhD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Institut National de la Santé Et de la Recherche Médicale, France
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02853019    
Other Study ID Numbers: 6152
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Strasbourg, France:
Emotion
motivation
cognition
schizophrenia
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders