SchizophreniaNCT03338179
Evaluation of Metamemory in Patients With Schizophrenia
A study testing Judgement of learning evaluation in people with Schizophrenia and Aging, run by University Hospital, Clermont-Ferrand at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Aging
- What is being tested?
- Judgement of learning evaluation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 8 Feb 2011to 23 May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
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- 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
Who cannot join
- -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:
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Schizophrenia, Aging
- Being tested
- Judgement of learning evaluation
- Keywords
- Metamemory, Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Judgement of learning evaluationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Adult Patients | Experimental | Schizophrenia patients aged between 18 and 45 years old Receives: Behavioral: Judgement of learning evaluation |
| Aged Patients | Experimental | Schizophrenia patients aged 59.5 years and above Receives: Behavioral: Judgement of learning evaluation |
| Adult Controls | Active comparator | Controls aged between 18 and 45 years old Receives: Behavioral: Judgement of learning evaluation |
| Aged Controls | Active comparator | Controls aged 59.5 years and above Receives: Behavioral: Judgement of learning evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at day 1
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start8 Feb 2011
- Primary completion23 May 2016
- Study completion23 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- LAPSCO, Psychology University, Blaise Pascal University, Clermont-Ferrand.
- Responsible party
- Sponsor
- Investigators
- Isabelle JALENQUES, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03338179
- Sponsor's protocol ID
- CHU-360
- Other IDs
- 2010-A00857-32
- Status last verified
- Jul 2026
- First submitted
- 7 Nov 2017
- Last updated
- 3 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Metamemory in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT03338179
- Acronym / sponsor ID
- CHU-360
- Conditions
- Schizophrenia, Aging
- Keywords
- Metamemory, Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- LAPSCO, Psychology University, Blaise Pascal University, Clermont-Ferrand.
- Study start
- 8 Feb 2011 (actual)
- Primary completion
- 23 May 2016 (actual)
- Study completion
- 23 May 2016 (actual)
- First posted
- 9 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Adult Patients | Experimental | Behavioral: Judgement of learning evaluationSchizophrenia patients aged between 18 and 45 years old |
| Aged Patients | Experimental | Behavioral: Judgement of learning evaluationSchizophrenia patients aged 59.5 years and above |
| Adult Controls | Active comparator | Behavioral: Judgement of learning evaluationControls aged between 18 and 45 years old |
| Aged Controls | Active comparator | Behavioral: Judgement of learning evaluationControls aged 59.5 years and above |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- For both:
- Age: between 18 and 45 years for adults, and 59.55 and above for older,
- 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,
Key exclusion criteria (12 listed)
- -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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Judgement of learning evaluationThe 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. | Behavioural | Adult Controls, Adult Patients, Aged Controls, Aged Patients |
Primary outcome
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.
3 secondary outcomes
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
Difference of number of recalled word using a generation strategy
Time frame: at day 1
Difference of number of recalled word between generation and reading strategies
Time frame: at day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle JALENQUES principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Judgement of learning evaluation in people with Schizophrenia and Aging, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference of judgement of learning using a 5 point scale (0%, 25%, 50%, 75%, 100%) using a generation strategy. (time frame: at day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.