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Completed

NCT Number: NCT03338179

Evaluation of Metamemory in Patients With Schizophrenia

The purpose of this study is to determine the respective roles of aging and schizophrenia in the regulation of metamemory using a generation strategy. 4 groups will be necessary to comparison:

Adult patients (18-45 years) Adult controls (18-45 years) Aged patients (≥ 59.5 years) Aged controls (≥ 59.5 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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 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 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, generating instruction of a pair of words to learn is proposed: a word index is presented to the participants who have to generate a pair with a target word. Participants are trained on 5 pairs of words.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • For both:
  • Age: between 18 and 45 years for adults, and 59.55 and above for older,

For patients :

  • DSM-5 criteria of schizophrenia
  • Adult patients (<45 years) will be matched to elderly patients (> 59.55 years) gender and educational level,
  • 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 educational level (+/- 2 years) to patients

Exclusion criteria

  • -For patients :
  • Any other comorbid psychiatric diagnosis of Axis I DSM-5 (particularly depression, addiction excluding tobacco, dementia)
  • Patients with impaired vision or hearing preventing the realization of the tests.
  • Long-term Anticholinergic treatment.
  • Patients with less 5 years of school

For controls:

  • Any psychiatric diagnosis according to DSM-5, including addictions (excluding tobacco)
  • Head injuries, brain injuries or diseases,
  • vision or hearing problems preventing the realization of the tests.
  • Current or past addiction to all toxic substances except tobacco.
  • Long-term Anticholinergic treatment.
  • Related to the first degree diagnosed with a psychotic disorder

Treatment and study plan

Judgement of learning evaluation

Behavioral

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.

Primary outcomes

  1. difference of judgement of learning using a 5 point scale (0%, 25%, 50%, 75%, 100%) using a generation 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%) with the generation strategy.

Secondary outcomes

  1. Difference of judgement of learning using a 5 point scale (0%, 25%, 50%, 75%, 100%) between generation 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 generation strategy and in a reading strategy.

  2. Difference of number of recalled word using a generation strategy

    Time frame: at day 1

    the 4 groups of participants formed by the case-control study in two age strata recalled the word they learn using a generation strategy.

  3. Difference of number of recalled word between generation and reading strategies

    Time frame: at day 1

    the 4 groups of participants formed by the case-control study in two age strata recalled the word they learn using a generation strategy and a reading strategy.

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • LAPSCO, Psychology University, Blaise Pascal University, Clermont-Ferrand.

Registry information

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Nov 9, 2017
Registry last updated
Nov 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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