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Evaluation of Stroop Effect in Patients With Schizophrenia (STROOP)

Primary Purpose

Schizophrenia

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Modified Stroop effect
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Schizophrenia focused on measuring Schizophrenia, Stroop effect, Semantic conflict, Response conflict

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

For both:

  • MMSE score greater than or equal to, 22 if no grade ; 23 if study certificate or CAP or college without patent ; 25 if patent or school without the tray ; 26 or more when bin
  • IQ ≥ 75 (fNART)
  • Lextale score ≥ 28
  • Age: between 18 and 45 years

For patients :

  • DSM-5 criteria of schizophrenia
  • Patients followed as outpatients,
  • Age of onset of the disease less than 40 years,
  • Patients whose disease has stabilized: no changes psychotropic treatment for at least 1 month
  • Not more of a benzodiazepine,
  • Patients on protection of justice or not,

For controls :

  • Matched for sex to patient
  • Age-matched (+/- 3 years) to patient
  • Matched for IQ (score fNART +/- 10% to patients
  • Matched for Lextale score+/- 10% to patients

Exclusion Criteria:

For patients :

  • Any other comorbid psychiatric diagnosis of Axis I DSM-5
  • Extrapyramidal syndrome or tardive dyskinesia (AIMS score <2 BARS score <2 and score Simpson and Angus <3)
  • Calgary depression scale ≥ 6
  • Current or past addiction to all toxic substances (including alcohol and cannabis) except tobacco.
  • Current or past use of all toxic consumption (excluding alcohol, tobacco and cannabis).
  • Use of alcohol or cannabis before the age of 15 years
  • Alcohol abuse in the past 6 months.
  • Cannabis abuse in the past 6 months and cannabis use in the last 3 months.
  • Patients with impaired vision or hearing preventing the realization of the tests.

For controls:

  • Any psychiatric diagnosis according to DSM-5, including addictions (excluding tobacco)
  • Score HADS Anxiety ≥ 8 and Depression ≥ 8
  • SCL90R: global severity score GSI> 0.33 for women and> 0.27 for men, or score diversity PST symptoms> 18.49 for men and> 21.97 for women or score of degree of discomfort PSDI> 1.27 for men and> 1.3 for women, scoring in the subscale Psychotic Features> 0.
  • Presence of a personality disorder at PDQ4 +
  • Head injuries, brain injuries or diseases,
  • vision or hearing problems preventing the realization of the tests.
  • Current or past addiction to all toxic substances (including alcohol and cannabis) except tobacco.
  • Current or past use of all toxic consumption (excluding alcohol, tobacco and cannabis).
  • Long-term Anticholinergic treatment.
  • Related to the first degree diagnosed with a psychotic disorder

Sites / Locations

  • CHU Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Schizophrenia patients

Control group

Arm Description

Patients with DSM-5 criteria of schizophrenia

Control, no schizophrenia

Outcomes

Primary Outcome Measures

Semantic conflict in stroop test
The stroop effect consists of the semantic and the response conflict. In patients with schizophrenia, the stroop effect is longer than in controls. By comparing the stroop effect and the semantic conflict between patients and controls, we can determine whether the slowing observed in patients is due to a general slowdown (semantic and response conflict) or specific slowness (semantic or response conflict).

Secondary Outcome Measures

Response conflict in stroop test
The stroop effect consists of the semantic and the response conflict. In patients with schizophrenia, the stroop effect is longer than in controls. Response conflict (time in milliseconds) is obtained by subtracting the semantic conflict (time in milliseconds obtained in the second step of the protocol) from the stroop effect (time in milliseconds obtained in the first step of the protocol). Therefore, we can determine whether the slowing observed in patients is due to a general slowdown (semantic and response conflict) or specific slowness (semantic or response conflict).

Full Information

First Posted
May 11, 2017
Last Updated
May 22, 2017
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Université d'Auvergne
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1. Study Identification

Unique Protocol Identification Number
NCT03163706
Brief Title
Evaluation of Stroop Effect in Patients With Schizophrenia
Acronym
STROOP
Official Title
Evaluation of Stroop Effect in Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 21, 2016 (Actual)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Université d'Auvergne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The main objective of this study is to assess whether attention deficits and executive functions in patients with schizophrenia are general (semantic and response conflict) or specific (semantic or response conflict).
Detailed Description
First, participants will receive six categories of stimuli presented in a classical way: (1) incongruous stimulus classical (BLUE written in green for example); (2) associated incongruous stimuli (SKY written in green for example); (3) conventional congruent stimuli (BLUE written in blue for example); (4) associated congruent stimuli (SKY written in blue for example); (5) neutral words (BRIDGE written in green for example); And (6) neutral stimulus (XXXX written in green for example). In a second step (after a 5 minute break), they will receive these six categories of stimuli, but only half will be presented in a classic way and the other half will be presented in order to attract attention as in Augustinova and Ferrand 2007). To do this, in (1) incongruous stimuli classical like BLUE, a single letter (like B for example) will be colored in green for example and the rest of the word (LUE) will appear in gray); In (2) incongruous stimuli associated as SKY, only K for example will be green and the rest of the word will appear in gray); In (3) conventional congruent stimuli such as BLUE, only B for example will be written in blue and the rest of the word will appear in gray); In (4) associated congruent stimuli such as SKY only K for example will be written in blue and the rest of the word will appear in gray); In (5) neutral words like BRIDGE, only D will be colored in green for example and the rest of the word will appear in gray; And finally, in (6) neutral stimuli like XXXX, only one X will be colored in green for example and the rest of the X will appear in gray. The task will be to name the color of each word (by stating the color verbally) as quickly and correctly as possible, while ignoring the written word. In this experiment, we will measure the time taken to denominate the color (in milliseconds) as well as the percentages of incorrect answers. The first step allows to determine the stroop effect and the second the semantic conflict.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Stroop effect, Semantic conflict, Response conflict

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Open
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Schizophrenia patients
Arm Type
Experimental
Arm Description
Patients with DSM-5 criteria of schizophrenia
Arm Title
Control group
Arm Type
Other
Arm Description
Control, no schizophrenia
Intervention Type
Behavioral
Intervention Name(s)
Modified Stroop effect
Intervention Description
to assess whether attention deficits and executive functions in patients with schizophrenia are general (semantic and response conflict) or specific (semantic or response conflict).
Primary Outcome Measure Information:
Title
Semantic conflict in stroop test
Description
The stroop effect consists of the semantic and the response conflict. In patients with schizophrenia, the stroop effect is longer than in controls. By comparing the stroop effect and the semantic conflict between patients and controls, we can determine whether the slowing observed in patients is due to a general slowdown (semantic and response conflict) or specific slowness (semantic or response conflict).
Time Frame
at day 1
Secondary Outcome Measure Information:
Title
Response conflict in stroop test
Description
The stroop effect consists of the semantic and the response conflict. In patients with schizophrenia, the stroop effect is longer than in controls. Response conflict (time in milliseconds) is obtained by subtracting the semantic conflict (time in milliseconds obtained in the second step of the protocol) from the stroop effect (time in milliseconds obtained in the first step of the protocol). Therefore, we can determine whether the slowing observed in patients is due to a general slowdown (semantic and response conflict) or specific slowness (semantic or response conflict).
Time Frame
at day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: For both: MMSE score greater than or equal to, 22 if no grade ; 23 if study certificate or CAP or college without patent ; 25 if patent or school without the tray ; 26 or more when bin IQ ≥ 75 (fNART) Lextale score ≥ 28 Age: between 18 and 45 years For patients : DSM-5 criteria of schizophrenia Patients followed as outpatients, Age of onset of the disease less than 40 years, Patients whose disease has stabilized: no changes psychotropic treatment for at least 1 month Not more of a benzodiazepine, Patients on protection of justice or not, For controls : Matched for sex to patient Age-matched (+/- 3 years) to patient Matched for IQ (score fNART +/- 10% to patients Matched for Lextale score+/- 10% to patients Exclusion Criteria: For patients : Any other comorbid psychiatric diagnosis of Axis I DSM-5 Extrapyramidal syndrome or tardive dyskinesia (AIMS score <2 BARS score <2 and score Simpson and Angus <3) Calgary depression scale ≥ 6 Current or past addiction to all toxic substances (including alcohol and cannabis) except tobacco. Current or past use of all toxic consumption (excluding alcohol, tobacco and cannabis). Use of alcohol or cannabis before the age of 15 years Alcohol abuse in the past 6 months. Cannabis abuse in the past 6 months and cannabis use in the last 3 months. Patients with impaired vision or hearing preventing the realization of the tests. For controls: Any psychiatric diagnosis according to DSM-5, including addictions (excluding tobacco) Score HADS Anxiety ≥ 8 and Depression ≥ 8 SCL90R: global severity score GSI> 0.33 for women and> 0.27 for men, or score diversity PST symptoms> 18.49 for men and> 21.97 for women or score of degree of discomfort PSDI> 1.27 for men and> 1.3 for women, scoring in the subscale Psychotic Features> 0. Presence of a personality disorder at PDQ4 + Head injuries, brain injuries or diseases, vision or hearing problems preventing the realization of the tests. Current or past addiction to all toxic substances (including alcohol and cannabis) except tobacco. Current or past use of all toxic consumption (excluding alcohol, tobacco and cannabis). Long-term Anticholinergic treatment. Related to the first degree diagnosed with a psychotic disorder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle JALENQUES
Phone
04 73 75 48 78
Email
ijalenques@chu-clermontferrand.fr
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
State/Province
Auvergne
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Isabelle JALENQUES
Phone
04 73 75 48 78
Email
ijalenques@chu-clermontferrand.fr

12. IPD Sharing Statement

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Evaluation of Stroop Effect in Patients With Schizophrenia

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