Evaluation of Metamemory in Patients With Schizophrenia
Primary Purpose
Schizophrenia, Aging
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Judgement of learning evaluation
Sponsored by
About this trial
This is an interventional basic science trial for Schizophrenia focused on measuring Metamemory, Schizophrenia
Eligibility Criteria
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
Sites / Locations
- CHU Clermont-Ferrand
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Active Comparator
Arm Label
Adult Patients
Aged Patients
Adult Controls
Aged Controls
Arm Description
Schizophrenia patients aged between 18 and 45 years old
Schizophrenia patients aged 59.5 years and above
Controls aged between 18 and 45 years old
Controls aged 59.5 years and above
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT03338179
First Posted
November 7, 2017
Last Updated
November 10, 2017
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
LAPSCO, Psychology University, Blaise Pascal University, Clermont-Ferrand.
1. Study Identification
Unique Protocol Identification Number
NCT03338179
Brief Title
Evaluation of Metamemory in Patients With Schizophrenia
Official Title
Evaluation of Metamemory in Patients With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
February 8, 2011 (Actual)
Primary Completion Date
May 23, 2016 (Actual)
Study Completion Date
May 23, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
LAPSCO, Psychology University, Blaise Pascal University, Clermont-Ferrand.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Aging
Keywords
Metamemory, Schizophrenia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
no masking
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adult Patients
Arm Type
Experimental
Arm Description
Schizophrenia patients aged between 18 and 45 years old
Arm Title
Aged Patients
Arm Type
Experimental
Arm Description
Schizophrenia patients aged 59.5 years and above
Arm Title
Adult Controls
Arm Type
Active Comparator
Arm Description
Controls aged between 18 and 45 years old
Arm Title
Aged Controls
Arm Type
Active Comparator
Arm Description
Controls aged 59.5 years and above
Intervention Type
Behavioral
Intervention Name(s)
Judgement of learning evaluation
Intervention 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.
Primary Outcome Measure Information:
Title
difference of judgement of learning using a 5 point scale (0%, 25%, 50%, 75%, 100%) using a generation strategy.
Description
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.
Time Frame
at day 1
Secondary Outcome Measure Information:
Title
Difference of judgement of learning using a 5 point scale (0%, 25%, 50%, 75%, 100%) between generation and reading strategies
Description
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.
Time Frame
at day 1
Title
Difference of number of recalled word using a generation strategy
Description
the 4 groups of participants formed by the case-control study in two age strata recalled the word they learn using a generation strategy.
Time Frame
at day 1
Title
Difference of number of recalled word between generation and reading strategies
Description
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.
Time Frame
at day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle JALENQUES
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
12. IPD Sharing Statement
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Evaluation of Metamemory in Patients With Schizophrenia
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