NCT03163706

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 21, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 23, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

May 23, 2017

Status Verified

May 1, 2017

Enrollment Period

2 years

First QC Date

May 11, 2017

Last Update Submit

May 22, 2017

Conditions

Schizophrenia

Keywords

SchizophreniaStroop effectSemantic conflictResponse conflict

Outcome Measures

Primary Outcomes (1)

  • 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).

    at day 1

Secondary Outcomes (1)

  • Response conflict in stroop test

    at day 1

Study Arms (2)

Schizophrenia patients

EXPERIMENTAL

Patients with DSM-5 criteria of schizophrenia

Behavioral: Modified Stroop effect

Control group

OTHER

Control, no schizophrenia

Behavioral: Modified Stroop effect

Interventions

Modified Stroop effectBEHAVIORAL

to assess whether attention deficits and executive functions in patients with schizophrenia are general (semantic and response conflict) or specific (semantic or response conflict).

Control groupSchizophrenia patients

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • +2 more criteria

You may not qualify if:

  • 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 +
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63003, France

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Isabelle JALENQUES

CONTACT

04 73 75 48 78ijalenques@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Open
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2017

First Posted

May 23, 2017

Study Start

September 21, 2016

Primary Completion

October 1, 2018

Study Completion

June 1, 2019

Last Updated

May 23, 2017

Record last verified: 2017-05

Locations

FR(1)