NCT02932059

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

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable schizophrenia

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

June 19, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

July 27, 2017

Status Verified

October 1, 2016

Enrollment Period

2.6 years

First QC Date

October 4, 2016

Last Update Submit

July 25, 2017

Conditions

Keywords

MetamemorySchizophreniaAgingLearningJudgement of learningSentence construction strategy

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)

EXPERIMENTAL

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

Behavioral: Metamemory

Aged patients with schizophrenia (≥ 55 years)

EXPERIMENTAL

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

Behavioral: Metamemory

Adults controls (18-45 years)

EXPERIMENTAL

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

Behavioral: Metamemory

Aged Controls (≥ 55 years)

EXPERIMENTAL

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

Behavioral: Metamemory

Interventions

MetamemoryBEHAVIORAL

Metamemory evaluation using a sentence construction strategy

Adult schizophrenic patients (18-45 years)Adults controls (18-45 years)Aged Controls (≥ 55 years)Aged patients with schizophrenia (≥ 55 years)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Isabelle JALENQUES

    CHU Clermont-Ferrrand

    PRINCIPAL INVESTIGATOR

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

Locations