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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03338179
Other study ID # CHU-360
Secondary ID 2010-A00857-32
Status Completed
Phase N/A
First received November 7, 2017
Last updated November 10, 2017
Start date February 8, 2011
Est. completion date May 23, 2016

Study information

Verified date November 2017
Source University Hospital, Clermont-Ferrand
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date May 23, 2016
Est. primary completion date May 23, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
France CHU Clermont-Ferrand Clermont-Ferrand

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand LAPSCO, Psychology University, Blaise Pascal University, Clermont-Ferrand.

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
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