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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02853019
Other study ID # 6152
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 2, 2017
Est. completion date June 2025

Study information

Verified date August 2023
Source University Hospital, Strasbourg, France
Contact Anne GIERSCH
Phone 03 88 11 64 71
Email giersch@unistra.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date June 2025
Est. primary completion date June 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France Unité INSERM 1114 Strasbourg

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in the amplitude of the CNV (Contingent Negative Variation) as a function of the primer displayed on the screen 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. During EEG sessions, at experimental session 1 (Day 0) and experimental session 2 (up to Day 120)
Secondary Change in the amplitude of the LPP (Late Positive Potential) as a function of the primer displayed on the screen 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. During EEG sessions, at experimental session 1 (Day 0) and experimental session 2 (up to Day 120)
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