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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Aging
• Intervention / Treatment: Behavioral: Judgement of learning evaluation

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 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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Chu Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adult Patients; Schizophrenia patients aged between 18 and 45 years old	Behavioral: Judgement of learning evaluation; 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.
Experimental: Aged Patients; Schizophrenia patients aged 59.5 years and above	Behavioral: Judgement of learning evaluation; 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.
Active Comparator: Adult Controls; Controls aged between 18 and 45 years old	Behavioral: Judgement of learning evaluation; 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.
Active Comparator: Aged Controls; Controls aged 59.5 years and above	Behavioral: Judgement of learning evaluation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
difference of judgement of learning using a 5 point scale (0%, 25%, 50%, 75%, 100%) using a generation 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%) with the generation strategy.	at day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference of judgement of learning using a 5 point scale (0%, 25%, 50%, 75%, 100%) between generation 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 generation strategy and in a reading strategy.	at day 1
Difference of number of recalled word using a generation strategy	the 4 groups of participants formed by the case-control study in two age strata recalled the word they learn using a generation strategy.	at day 1
Difference of number of recalled word between generation and reading strategies	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.	at day 1

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: LAPSCO, Psychology University, Blaise Pascal University, Clermont-Ferrand.
• Investigators: Principal Investigator: Isabelle JALENQUES, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2011
• Primary Completion (Actual): May 23, 2016
• Study Completion (Actual): May 23, 2016

Study Registration Dates

• First Submitted: November 7, 2017
• First Submitted That Met QC Criteria: November 7, 2017
• First Posted (Actual): November 9, 2017

Study Record Updates

• Last Update Posted (Actual): November 14, 2017
• Last Update Submitted That Met QC Criteria: November 10, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Schizophrenia; Metamemory
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: CHU-360; 2010-A00857-32 (Other Identifier: 2010-A00857-32)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No