SchizophreniaMetamemory 2NCT02932059
Evaluation of Metamemory Using a Semantic Construction Strategy in Patients With Schizophrenia
A study testing Metamemory 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 sentence construction strategy. 4 groups will be necessary to comparison: Adult patients (18-45 years) Adult controls (18-45 years) Aged patients (≥ 55 years) Aged controls (≥ 55 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?
- Metamemory
- 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
- 19 Jun 2017to Sep 2020
- 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:
- MMSE score greater than or equal to,
- 22 if no grade
- 23 if study certificate or CAP or college without patent
- 25 if patent or school without the tray
- 26 or more when bin
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- IQ ≥ 75 (fNART)
- Age: between 18 and 45 years for adults, and 55 and older for older,
- For patients :
- DSM-5 criteria of schizophrenia
- Adult patients (<45 years) will be matched to elderly patients (> 55 years) gender and IQ,
- 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 IQ (score fNART +/- 10%) to patients
Who cannot join
- For patients :
- Any other comorbid psychiatric diagnosis of Axis I DSM-5
- Extrapyramidal syndrome or tardive dyskinesia (AIMS score <2 BARS score <2 and score Simpson and Angus <3)
- Calgary depression scale ≥ 6
- Current or past addiction to all toxic substances (including alcohol and cannabis) except tobacco.
- Current or past use of all toxic consumption (excluding alcohol, tobacco and cannabis).
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- Use of alcohol or cannabis before the age of 15 years
- Alcohol abuse in the past 6 months.
- Cannabis abuse in the past 6 months and cannabis use in the last 3 months.
- Patients with impaired vision or hearing preventing the realization of the tests.
- For controls:
- Any psychiatric diagnosis according to DSM-5, including addictions (excluding tobacco)
- Score HADS Anxiety ≥ 8 and Depression ≥ 8
- SCL90R: global severity score GSI> 0.33 for women and> 0.27 for men, or score diversity PST symptoms> 18.49 for men and> 21.97 for women or score of degree of discomfort PSDI> 1.27 for men and> 1.3 for women, scoring in the subscale Psychotic Features> 0.
- Presence of a personality disorder at PDQ4 +
- Head injuries, brain injuries or diseases,
- vision or hearing problems preventing the realization of the tests.
- Current or past addiction to all toxic substances (including alcohol and cannabis) except tobacco.
- Current or past use of all toxic consumption (excluding alcohol, tobacco and cannabis).
- Long-term Anticholinergic treatment.
- Related to the first degree diagnosed with a psychotic disorder
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Isabelle JALENQUES
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 sentence construction strategy. 4 groups will be necessary to comparison:
Adult patients (18-45 years) Adult controls (18-45 years) Aged patients (≥ 55 years) Aged controls (≥ 55 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 first 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 (judgments of learning ) 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, building instruction of a phrase with two words to learn is proposed. Participants are trained on 5 pairs of words. The study concludes with a question phase, during which participants give their impressions of the experience, describe the learning strategies they used and generally consider their ability mnemonic during daily tasks.
- Conditions
- Schizophrenia, Aging
- Being tested
- Metamemory
- Keywords
- Metamemory, Schizophrenia, Aging, Learning, Judgement of learning, Sentence construction strategy
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetamemoryBehavioural
Metamemory evaluation using a sentence construction strategy
| Study group | Role | What they receive |
|---|---|---|
| Adult schizophrenic patients (18-45 years) | Experimental | 4 groups formed by the case-control study in two age strata Receives: Behavioral: Metamemory |
| Aged patients with schizophrenia (≥ 55 years) | Experimental | 4 groups formed by the case-control study in two age strata Receives: Behavioral: Metamemory |
| Adults controls (18-45 years) | Experimental | 4 groups formed by the case-control study in two age strata Receives: Behavioral: Metamemory |
| Aged Controls (≥ 55 years) | Experimental | 4 groups formed by the case-control study in two age strata Receives: Behavioral: Metamemory |
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%) in the sentence construction 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%) in the sentence construction strategy.
Four groups are :
- Adult schizophrenic patients (18-45 years)
- Aged patients with schizophrenia (≥ 55 years)
- Adults controls (18-45 years)
- Aged controls (≥ 55 years)
Measured: at day 1
Secondary outcomes (1)
difference of judgement of learning using a 5 point scale (0%, 25%, 50%, 75%, 100%) between sentence construction 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 sentence construction strategy and in a reading strategy.
For each group, difference between these two strategies will be compared.
Four groups are :
- Adult schizophrenic patients (18-45 years)
- Aged patients with schizophrenia (≥ 55 years)
- Adults controls (18-45 years)
- Aged controls (≥ 55 years)
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 posted13 Oct 2016 (estimated)
- Study start19 Jun 2017
- Primary completionFeb 2020 (estimated)
- Study completionSep 2020 (estimated)
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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
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, CHU Clermont-Ferrrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02932059
- Sponsor's protocol ID
- CHU-0280
- Other IDs
- 2016-A00944-47
- Acronym
- Metamemory 2
- Status last verified
- Oct 2016
- First submitted
- 4 Oct 2016
- Last updated
- 27 Jul 2017
- 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 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Metamemory Using a Semantic Construction Strategy in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT02932059
- Acronym / sponsor ID
- Metamemory 2 / CHU-0280
- Conditions
- Schizophrenia, Aging
- Keywords
- Metamemory, Schizophrenia, Aging, Learning, Judgement of learning, Sentence construction strategy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- LAPSCO, Psychology University, Blaise Pascal University, Clermont-Ferrand.
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 13 Oct 2016 (estimated)
- 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 sentence construction strategy. 4 groups will be necessary to comparison:
Adult patients (18-45 years) Adult controls (18-45 years) Aged patients (≥ 55 years) Aged controls (≥ 55 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 first 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 (judgments of learning ) 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, building instruction of a phrase with two words to learn is proposed. Participants are trained on 5 pairs of words. The study concludes with a question phase, during which participants give their impressions of the experience, describe the learning strategies they used and generally consider their ability mnemonic during daily tasks.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Adult schizophrenic patients (18-45 years) | Experimental | Behavioral: Metamemory4 groups formed by the case-control study in two age strata |
| Aged patients with schizophrenia (≥ 55 years) | Experimental | Behavioral: Metamemory4 groups formed by the case-control study in two age strata |
| Adults controls (18-45 years) | Experimental | Behavioral: Metamemory4 groups formed by the case-control study in two age strata |
| Aged Controls (≥ 55 years) | Experimental | Behavioral: Metamemory4 groups formed by the case-control study in two age strata |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- For both:
- MMSE score greater than or equal to,
- IQ ≥ 75 (fNART)
- Age: between 18 and 45 years for adults, and 55 and older for older,
- DSM-5 criteria of schizophrenia
Key exclusion criteria (21 listed)
- For patients :
- Any other comorbid psychiatric diagnosis of Axis I DSM-5
- Extrapyramidal syndrome or tardive dyskinesia (AIMS score <2 BARS score <2 and score Simpson and Angus <3)
- Calgary depression scale ≥ 6
- Current or past addiction to all toxic substances (including alcohol and cannabis) except tobacco.
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 |
|---|---|---|
| MetamemoryMetamemory evaluation using a sentence construction strategy | Behavioural | Adult schizophrenic patients (18-45 years), Adults controls (18-45 years), Aged Controls (≥ 55 years), Aged patients with schizophrenia (≥ 55 years) |
Primary outcome
difference of judgement of learning using a 5 point scale (0%, 25%, 50%, 75%, 100%) in the sentence construction 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%) in the sentence construction strategy. Four groups are : * Adult schizophrenic patients (18-45 years) * Aged patients with schizophrenia (≥ 55 years) * Adults controls (18-45 years) * Aged controls (≥ 55 years)
1 secondary outcome
difference of judgement of learning using a 5 point scale (0%, 25%, 50%, 75%, 100%) between sentence construction and reading strategies.
Time frame: at day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2017.
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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
CHU Clermont-Ferrrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metamemory 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 20 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 27 Jul 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. 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%) in the sentence construction 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 27 Jul 2017.