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Evaluation of Metamemory Using a Semantic Construction Strategy in Patients With Schizophrenia (Metamemory 2)

Primary Purpose

Schizophrenia, Aging

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Metamemory
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 Metamemory, Schizophrenia, Aging, Learning, Judgement of learning, Sentence construction strategy

Eligibility Criteria

18 Years - undefined (Adult, Older 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)
  • Age: between 18 and 45 years for adults, and 55 and older for older,

For patients :

  • DSM-5 criteria of schizophrenia
  • Adult patients (<45 years) will be matched to elderly patients (> 55 years) gender and IQ,
  • 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

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 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Adult schizophrenic patients (18-45 years)

Aged patients with schizophrenia (≥ 55 years)

Adults controls (18-45 years)

Aged Controls (≥ 55 years)

Arm Description

4 groups formed by the case-control study in two age strata

4 groups formed by the case-control study in two age strata

4 groups formed by the case-control study in two age strata

4 groups formed by the case-control study in two age strata

Outcomes

Primary Outcome Measures

difference of judgement of learning using a 5 point scale (0%, 25%, 50%, 75%, 100%) in the sentence construction strategy
the 4 groups of participants formed by the case-control study in two age strata value their judgments of learning for each pair of words using a 5 point scale (0%, 25%, 50%, 75%, 100%) in the sentence construction strategy. Four groups are : Adult schizophrenic patients (18-45 years) Aged patients with schizophrenia (≥ 55 years) Adults controls (18-45 years) Aged controls (≥ 55 years)

Secondary Outcome Measures

difference of judgement of learning using a 5 point scale (0%, 25%, 50%, 75%, 100%) between sentence construction and reading strategies.
the 4 groups of participants formed by the case-control study in two age strata, value their judgments of learning for each pair of words using a 5 point scale (0%, 25%, 50%, 75%, 100%) in a sentence construction strategy and in a reading strategy. For each group, difference between these two strategies will be compared. Four groups are : Adult schizophrenic patients (18-45 years) Aged patients with schizophrenia (≥ 55 years) Adults controls (18-45 years) Aged controls (≥ 55 years)

Full Information

First Posted
October 4, 2016
Last Updated
July 25, 2017
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
LAPSCO, Psychology University, Blaise Pascal University, Clermont-Ferrand.
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1. Study Identification

Unique Protocol Identification Number
NCT02932059
Brief Title
Evaluation of Metamemory Using a Semantic Construction Strategy in Patients With Schizophrenia
Acronym
Metamemory 2
Official Title
Evaluation of Metamemory Using a Semantic Construction Strategy in Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 19, 2017 (Actual)
Primary Completion Date
February 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
LAPSCO, Psychology University, Blaise Pascal University, Clermont-Ferrand.

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 purpose of this study is to determine the respective roles of aging and schizophrenia in the regulation of metamemory using a sentence construction strategy. 4 groups will be necessary to comparison: Adult patients (18-45 years) Adult controls (18-45 years) Aged patients (≥ 55 years) Aged controls (≥ 55 years) The effects of age and the disease could lead to interaction in regulating metamemory. The effect of age would be aggravated by the disease.
Detailed Description
Metamemory measurement Objective: Measurement of monitoring and control capabilities, and relations between these two abilities when learning of word pairs. Description: The hardware consists of two lists of 30 pairs of French words, each pair of words being composed of a word index and a target word (names of concrete objects). Among the 60 word pairs, 30 are strongly associated items (or easy items, the other 30 being weakly associated or difficult items. In front of a computer screen, each participant is subjected to a first learning test in which 30 pairs of words appear one by one on the screen. Participants have the option to control the time of presentation of each pair of words. After a retention time of 4 minutes of information devoted to nonverbal distractive task, follows an evaluation phase of deferred judgments of learning (JOL time), where for each pair of words studied, the word index is presented without the target word. Participants must then assess a learning judgment for each pair of words, that is to say they have to estimate, on a 5-point scale, their ability to remember later the target word in the presentation the index word. This JOL (judgments of learning ) assessment phase is immediately followed by cued recall test. For the second learning test (30 other word pair), the steps are identical. Prior to this second learning, building instruction of a phrase with two words to learn is proposed. Participants are trained on 5 pairs of words. The study concludes with a question phase, during which participants give their impressions of the experience, describe the learning strategies they used and generally consider their ability mnemonic during daily tasks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Aging
Keywords
Metamemory, Schizophrenia, Aging, Learning, Judgement of learning, Sentence construction strategy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Adult schizophrenic patients (18-45 years)
Arm Type
Experimental
Arm Description
4 groups formed by the case-control study in two age strata
Arm Title
Aged patients with schizophrenia (≥ 55 years)
Arm Type
Experimental
Arm Description
4 groups formed by the case-control study in two age strata
Arm Title
Adults controls (18-45 years)
Arm Type
Experimental
Arm Description
4 groups formed by the case-control study in two age strata
Arm Title
Aged Controls (≥ 55 years)
Arm Type
Experimental
Arm Description
4 groups formed by the case-control study in two age strata
Intervention Type
Behavioral
Intervention Name(s)
Metamemory
Intervention Description
Metamemory evaluation using a sentence construction strategy
Primary Outcome Measure Information:
Title
difference of judgement of learning using a 5 point scale (0%, 25%, 50%, 75%, 100%) in the sentence construction strategy
Description
the 4 groups of participants formed by the case-control study in two age strata value their judgments of learning for each pair of words using a 5 point scale (0%, 25%, 50%, 75%, 100%) in the sentence construction strategy. Four groups are : Adult schizophrenic patients (18-45 years) Aged patients with schizophrenia (≥ 55 years) Adults controls (18-45 years) Aged controls (≥ 55 years)
Time Frame
at day 1
Secondary Outcome Measure Information:
Title
difference of judgement of learning using a 5 point scale (0%, 25%, 50%, 75%, 100%) between sentence construction and reading strategies.
Description
the 4 groups of participants formed by the case-control study in two age strata, value their judgments of learning for each pair of words using a 5 point scale (0%, 25%, 50%, 75%, 100%) in a sentence construction strategy and in a reading strategy. For each group, difference between these two strategies will be compared. Four groups are : Adult schizophrenic patients (18-45 years) Aged patients with schizophrenia (≥ 55 years) Adults controls (18-45 years) Aged controls (≥ 55 years)
Time Frame
at day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 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) Age: between 18 and 45 years for adults, and 55 and older for older, For patients : DSM-5 criteria of schizophrenia Adult patients (<45 years) will be matched to elderly patients (> 55 years) gender and IQ, 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle JALENQUES
Organizational Affiliation
CHU Clermont-Ferrrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
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

12. IPD Sharing Statement

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Evaluation of Metamemory Using a Semantic Construction Strategy in Patients With Schizophrenia

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