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

This study is currently recruiting participants.
See Contacts and Locations
Verified October 2016 by University Hospital, Clermont-Ferrand
Sponsor:
Collaborator:
LAPSCO, Psychology University, Blaise Pascal University, Clermont-Ferrand.
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT02932059
First received: October 4, 2016
Last updated: July 25, 2017
Last verified: October 2016
  Purpose

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.


Condition Intervention
Schizophrenia Aging Behavioral: Metamemory

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of Metamemory Using a Semantic Construction Strategy in Patients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • difference of judgement of learning using a 5 point scale (0%, 25%, 50%, 75%, 100%) in the sentence construction strategy [ Time Frame: at day 1 ]

    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. [ Time Frame: at day 1 ]

    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)


Estimated Enrollment: 120
Actual Study Start Date: June 19, 2017
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: February 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adult schizophrenic patients (18-45 years)
4 groups formed by the case-control study in two age strata
Behavioral: Metamemory
Metamemory evaluation using a sentence construction strategy
Experimental: Aged patients with schizophrenia (≥ 55 years)
4 groups formed by the case-control study in two age strata
Behavioral: Metamemory
Metamemory evaluation using a sentence construction strategy
Experimental: Adults controls (18-45 years)
4 groups formed by the case-control study in two age strata
Behavioral: Metamemory
Metamemory evaluation using a sentence construction strategy
Experimental: Aged Controls (≥ 55 years)
4 groups formed by the case-control study in two age strata
Behavioral: Metamemory
Metamemory evaluation using a sentence construction strategy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02932059

Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Principal Investigator: Isabelle JALENQUES         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
LAPSCO, Psychology University, Blaise Pascal University, Clermont-Ferrand.
Investigators
Principal Investigator: Isabelle JALENQUES CHU Clermont-Ferrrand
  More Information

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02932059     History of Changes
Other Study ID Numbers: CHU-0280
2016-A00944-47 ( Other Identifier: 2016-A00944-47 )
Study First Received: October 4, 2016
Last Updated: July 25, 2017

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

Keywords provided by University Hospital, Clermont-Ferrand:
Metamemory
Schizophrenia
Aging
Learning
Judgement of learning
Sentence construction strategy

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 25, 2017