Back to resultsEmotion and Motivation in Patients With Psychosis
Primary Purpose
Schizophrenia
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Electroencephalogram
Cognitive tasks
subjective evaluation scales
Sponsored by
About this trial
This is an interventional other trial for Schizophrenia focused on measuring Emotion, motivation, cognition, schizophrenia
Eligibility 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
Sites / Locations
- Unité INSERM 1114Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Healthy volunteers
Patients with schizophrenia
Arm Description
Healthy volunteers
Patients with schizophrenia
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02853019
First Posted
May 23, 2016
Last Updated
August 18, 2023
Sponsor
University Hospital, Strasbourg, France
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT02853019
Brief Title
Emotion and Motivation in Patients With Psychosis
Official Title
Influence of Emotion and Motivation on Behaviour and Neural Activity in Patients With Psychosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2017 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Emotion, motivation, cognition, schizophrenia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healthy volunteers
Arm Type
Sham Comparator
Arm Description
Healthy volunteers
Arm Title
Patients with schizophrenia
Arm Type
Experimental
Arm Description
Patients with schizophrenia
Intervention Type
Other
Intervention Name(s)
Electroencephalogram
Intervention Description
electrophysiological measurements (evoked potentials) based on neural activity when visualizing stimuli
Intervention Type
Behavioral
Intervention Name(s)
Cognitive tasks
Intervention Description
- clinical scales and subjective assessments of emotional and motivational stimuli
Intervention Type
Behavioral
Intervention Name(s)
subjective evaluation scales
Intervention Description
- clinical scales and subjective assessments of emotional and motivational stimuli
Primary Outcome Measure Information:
Title
Change in the amplitude of the CNV (Contingent Negative Variation) as a function of the primer displayed on the screen
Description
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.
Time Frame
During EEG sessions, at experimental session 1 (Day 0) and experimental session 2 (up to Day 120)
Secondary Outcome Measure Information:
Title
Change in the amplitude of the LPP (Late Positive Potential) as a function of the primer displayed on the screen
Description
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.
Time Frame
During EEG sessions, at experimental session 1 (Day 0) and experimental session 2 (up to Day 120)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne GIERSCH
Phone
03 88 11 64 71
Email
giersch@unistra.fr
Facility Information:
Facility Name
Unité INSERM 1114
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne GIERSCH, MD, PhD
Phone
03 88 11 64 71
Email
giersch@unistra.fr
First Name & Middle Initial & Last Name & Degree
Pierre VIDAILHET, MD, PhD
First Name & Middle Initial & Last Name & Degree
Anne GIERSCH, MD, PhD
First Name & Middle Initial & Last Name & Degree
Fabrice BERNA, MD, PhD
First Name & Middle Initial & Last Name & Degree
Laurence LALANNE, MD, PhD
First Name & Middle Initial & Last Name & Degree
Sébastien WEIBEL, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Emotion and Motivation in Patients With Psychosis
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