Evaluation of Metamemory Using a Semantic Construction Strategy in Patients With Schizophrenia
Metamemory 2
2 other identifiers
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable schizophrenia
Started Jun 2017
Typical duration for not_applicable schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2016
CompletedFirst Posted
Study publicly available on registry
October 13, 2016
CompletedStudy Start
First participant enrolled
June 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedJuly 27, 2017
October 1, 2016
2.6 years
October 4, 2016
July 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
at day 1
Secondary Outcomes (1)
difference of judgement of learning using a 5 point scale (0%, 25%, 50%, 75%, 100%) between sentence construction and reading strategies.
at day 1
Study Arms (4)
Adult schizophrenic patients (18-45 years)
EXPERIMENTAL4 groups formed by the case-control study in two age strata
Aged patients with schizophrenia (≥ 55 years)
EXPERIMENTAL4 groups formed by the case-control study in two age strata
Adults controls (18-45 years)
EXPERIMENTAL4 groups formed by the case-control study in two age strata
Aged Controls (≥ 55 years)
EXPERIMENTAL4 groups formed by the case-control study in two age strata
Interventions
Metamemory evaluation using a sentence construction strategy
Eligibility Criteria
You may qualify if:
- For both:
- MMSE score greater than or equal to,
- if no grade
- if study certificate or CAP or college without patent
- if patent or school without the tray
- 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,
- +5 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, 63003, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Isabelle JALENQUES
CHU Clermont-Ferrrand
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2016
First Posted
October 13, 2016
Study Start
June 19, 2017
Primary Completion
February 1, 2020
Study Completion
September 1, 2020
Last Updated
July 27, 2017
Record last verified: 2016-10