Emotion and Motivation in Patients With Psychosis

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT02853019
Collaborator
Institut National de la Santé Et de la Recherche Médicale, France (Other)
100
1
2
75.9
1.3

Study Details

Study Description

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
  • Other: Electroencephalogram
  • Behavioral: Cognitive tasks
  • Behavioral: subjective evaluation scales
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Feb 2, 2017
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in the amplitude of the CNV (Contingent Negative Variation) as a function of the primer displayed on the screen [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Unité INSERM 1114 Strasbourg France 67091

Sponsors and Collaborators

  • University Hospital, Strasbourg, France
  • Institut National de la Santé Et de la Recherche Médicale, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT02853019
Other Study ID Numbers:
  • 6152
First Posted:
Aug 2, 2016
Last Update Posted:
Aug 19, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 19, 2022