At-risk Mental StatesEPEDIPNCT06539611
Prospective Cohort Study of a Population at Risk of Psychotic Transition
An observational study of At-risk Mental States, run by Centre Hospitalier Esquirol at 1 site in France.
Trial summary
In psychiatry, insight is the patient's awareness of his or her disorder or symptom. Lack of insight also seems to be associated with the presence of anxiety-depressive symptoms. Read more about this study
- Who is it for?
- Ages 15 to 30 years
- Conditions the study is for
- At-risk Mental States
- What is being tested?
- Observational
- How many people
- 125 participants
- Where
- 1 siteFrance
- Study dates
- 18 Nov 2024to 1 Mar 2030
- How long will I take part?
- 66 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 15 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All youth help-seekers assessed by early intervention team meeting the inclusion criteria will be asked to participate to the study.
Who may be able to join
- Male or female ;
- Be aged between 15 and 30 ;
- Being assessed by the eDIP (early intervention team "équipe de détection et d'intervention précoce") ;
- Sufficient level of French to understand and express yourself orally and in writing;
- For adults:
- Patients who have received informed information about the study and who have signed a consent to participate in the study;
- For minors: Patient who has received informed information about the study and who has signed, as well as the holders of parental authority the minor's consent to participate in the study.
Who cannot join
- Have already presented a First Psychotic Episode;
- Previous diagnosis of schizophrenia, psychotic disorder or bipolar disorder;
- Being on antipsychotic treatment at the time of inclusion ;
- Known intellectual disability ;
- Pregnant or breast-feeding woman;
- Minors and adults under legal protection.
Trial locations and contacts
1 site in 1 country.
About this study
In psychiatry, insight is the patient's awareness of his or her disorder or symptom. Lack of insight also seems to be associated with the presence of anxiety-depressive symptoms.
There are several forms of insight:
Read more
- clinical" insight, which is the perception of suffering from a given pathology or symptoms
- cognitive insight (CI), which is the ability to analyse or judge one's own thoughts, beliefs and judgements
- and the insight of cognitive disorders or the subjective perception of the cognitive alterations (or cognitive symptoms) presented. In this study, the investigators will refer to this dimension as 'subjective cognitive complaint' (SCP), in order to differentiate it from cognitive insight, the name of which may lead to confusion.
In schizophrenic disorders, there is a positive correlation between the subjective cognitive complaint SCC, and certain alterations in the neurocognitive assessment, including the attentional dimension. There are scales for collecting SCC in psychotic disorders, such as the SSTICS. To date, there is no scale validated specifically for the UHR population. Thus, the scales used (STICSS, SCoRS, etc.) are validated in populations presenting a characterised psychotic state. Objective impairment is measured during a neurocognitive assessment carried out by a specialised professional: a clinical psychologist specialised in neuropsychology. The cognitive performance of UHR patients is impaired, particularly in terms of cognitive flexibility and self-perception of cognitive disorders, and there may be a discrepancy between the complaint, the objective disorders and their identification as "disorders" by the patient.
Despite this discrepancy, to the investigators knowledge no study to date has investigated a possible link between SCC and psychotic transition in this population. Thus, it is not known whether social class may be a factor in exposure to transition, or whether there is a link at all between social class and risk of transition. The aim of this study is to determine psychotic transition in UHR in a 30 months follow-up, and to determine whether there is a link between SCC and transition.
- Conditions
- At-risk Mental States
- Being tested
- Observational
- Keywords
- at-risk mental states, early intervention, psychotic transition, subjective cognitive complaint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
This study is observationnal: Questionnaires to assess the endpoint
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Psychotic transition in UHR
Use of the CAARMS scale The section on positive symptoms uses a score of symptom intensity (out of 6 points) and frequency (out of 6 points) to determine whether the patient has reached a threshold of mild psychosis (UHR)
Measured: 30 months
Secondary outcomes (9)
Assessment of complaints versus absence of complaints in UHRs
Subjective Cognitive Complaint scale score in UHR within 3 months of assessment. The scale is called SSTICS Subjective Scale to Investigate Cognition in Schizphrenia. Minimal score: 0. Maximal score: 84. Higher scores are related to worse outcomes.
Measured: 3 months
Assessment of attentional impairment versus absence of attentional impairment in UHRs with cognitive complaint
Score at d2R test in the UHR population. d2-R test of attention is a neuropsychological measure of selective and sustained attention and visual scanning speed. The test is computerized. Three main variables are computed and the reported as norm-referenced scores: concentration performance, processed targets and accuracy. Three other variables have only their raw scores reported: errors of omission, errors of commission and errors of commission of "letter" type. Standardized scores consider a test taker's performance in the context of a suitable reference group. The reference group used in this study will be "european population, male and female, 18 - 55 years". The taker's score is plotted as a red line in a graph representing the reference group's performances. Score below 35 is significantly below average. Score over 65 is significantly above average. A higher score is associated with a better outcome.
Measured: 3 months
Date of psychotic transition in UHR patients
The date of transition will be evaluated based on the CAARMS subscale score between follow-up visits.
The CAARMS Comprehensive Assessment of At-Risk Mental States is a semi-structured assessment tool. The positive symptoms scale is graduated 1 to 6. A higher score is associated with more intense and frequent psychotic symptoms, meaning a worse outcome.
Measured: 30 months
Clinical factors associated with transition in UHR: insight scale BCIS
Score of Beck Cognitive Insight Scale
The beck cognitive insight scale is a 15-item self-report consisting of 2 subscales: self- reflectiveness and self-certainty. Overall, cognitive insight is calculated using a composite index, with higher self-reflectiveness relative to self-certainty being indicative of greater cognitive-insight. Composite index scores of three or lower represent low cognitive insight, and ten or above represent good cognitive insight (better outcome).
Measured: at baseline: day 1
Clinical factors associated with transition in UHR: self -esteem.
Score of Rosenberg self-esteem scale
The Rosenberg self-esteem scale ranges from 0 to 30. Scores below 15 suggest low self-esteem. Scores between 15 and 25 are within normal range (better outcome).
Measured: at baseline: day 1
Clinical factors associated with transition in UHR: depression
Score of Hamilton Depression Scale
Hamilton depression rating scale ranges from 0 to 54. Score 10- 13 mild depression, 14 to 17 mild to moderate, > 17 moderate to severe depression. Higher score means a worse outcome.
Measured: at baseline: day 1
Difference between three groups (NoP no psychosis, UHR and FEP first episode psychosis): insight scale
Score of Beck Cognitive Insight Scale
The beck cognitive insight scale is a 15-item self-report consisting of 2 subscales: self- reflectiveness and self-certainty. Overall, cognitive insight is calculated using a composite index, with higher self-reflectiveness relative to self-certainty being indicative of greater cognitive-insight. Composite index scores of three or lower represent low cognitive insight, and ten or above represent good cognitive insight (better outcome).
Measured: at baseline: day 1
Difference between three groups (NoP, UHR and FEP): self-esteem.
Score of Rosenberg self-esteem scale
The Rosenberg self-esteem scale ranges from 0 to 30. Scores below 15 suggest low self-esteem. Scores between 15 and 25 are within normal range (better outcome).
Measured: at baseline: day 1
Difference between three groups ((NoP, UHR and FEP): depression.
Score of Hamilton Depression Scale Hamilton depression rating scale ranges from 0 to 54. Score 10- 13 mild depression, 14 to 17 mild to moderate, > 17 moderate to severe depression. Higher score means a worse outcome.
Measured: at baseline: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start18 Nov 2024
- Primary completion18 Nov 2024
- Study completion1 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for At-risk Mental StatesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
- Target duration
- 66 Months
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Esquirol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Mirvat HAMDAN-DUMONT, Centre Hospitalier Esquirol
- Investigators
- Mirvat B HAMDAN-DUMONT, MD, Principal investigator, Hospital Esquirol Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539611
- Sponsor's protocol ID
- 2024-A00720-47
- Acronym
- EPEDIP
- Status last verified
- Dec 2025
- First submitted
- 29 Jul 2024
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of a Population at Risk of Psychotic Transition
- ClinicalTrials.gov ID
- NCT06539611
- Acronym / sponsor ID
- EPEDIP / 2024-A00720-47
- Conditions
- At-risk Mental States
- Keywords
- at-risk mental states, early intervention, psychotic transition, subjective cognitive complaint
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Centre Hospitalier EsquirolUniversity, hospital or other
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 18 Nov 2024 (actual)
- Study completion
- 1 Mar 2030 (estimated)
- First posted
- 6 Aug 2024 (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.
In psychiatry, insight is the patient's awareness of his or her disorder or symptom. Lack of insight also seems to be associated with the presence of anxiety-depressive symptoms.
There are several forms of insight:
- clinical" insight, which is the perception of suffering from a given pathology or symptoms
- cognitive insight (CI), which is the ability to analyse or judge one's own thoughts, beliefs and judgements
- and the insight of cognitive disorders or the subjective perception of the cognitive alterations (or cognitive symptoms) presented. In this study, the investigators will refer to this dimension as 'subjective cognitive complaint' (SCP), in order to differentiate it from cognitive insight, the name of which may lead to confusion.
In schizophrenic disorders, there is a positive correlation between the subjective cognitive complaint SCC, and certain alterations in the neurocognitive assessment, including the attentional dimension. There are scales for collecting SCC in psychotic disorders, such as the SSTICS. To date, there is no scale validated specifically for the UHR population. Thus, the scales used (STICSS, SCoRS, etc.) are validated in populations presenting a characterised psychotic state. Objective impairment is measured during a neurocognitive assessment carried out by a specialised professional: a clinical psychologist specialised in neuropsychology. The cognitive performance of UHR patients is impaired, particularly in terms of cognitive flexibility and self-perception of cognitive disorders, and there may be a discrepancy between the complaint, the objective disorders and their identification as "disorders" by the patient.
Despite this discrepancy, to the investigators knowledge no study to date has investigated a possible link between SCC and psychotic transition in this population. Thus, it is not known whether social class may be a factor in exposure to transition, or whether there is a link at all between social class and risk of transition. The aim of this study is to determine psychotic transition in UHR in a 30 months follow-up, and to determine whether there is a link between SCC and transition.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 66 Months
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All youth help-seekers assessed by early intervention team meeting the inclusion criteria will be asked to participate to the study.
Key inclusion criteria (7 listed)
- Male or female ;
- Be aged between 15 and 30 ;
- Being assessed by the eDIP (early intervention team "équipe de détection et d'intervention précoce") ;
- Sufficient level of French to understand and express yourself orally and in writing;
- For adults:
Key exclusion criteria (6 listed)
- Have already presented a First Psychotic Episode;
- Previous diagnosis of schizophrenia, psychotic disorder or bipolar disorder;
- Being on antipsychotic treatment at the time of inclusion ;
- Known intellectual disability ;
- Pregnant or breast-feeding woman;
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 |
|---|---|---|
| ObservationalThis study is observationnal: Questionnaires to assess the endpoint | Other | – |
Primary outcome
Percent of Psychotic transition in UHR
Time frame: 30 months
Use of the CAARMS scale The section on positive symptoms uses a score of symptom intensity (out of 6 points) and frequency (out of 6 points) to determine whether the patient has reached a threshold of mild psychosis (UHR)
9 secondary outcomes
Assessment of complaints versus absence of complaints in UHRs
Time frame: 3 months
Assessment of attentional impairment versus absence of attentional impairment in UHRs with cognitive complaint
Time frame: 3 months
Date of psychotic transition in UHR patients
Time frame: 30 months
Clinical factors associated with transition in UHR: insight scale BCIS
Time frame: at baseline: day 1
Clinical factors associated with transition in UHR: self -esteem.
Time frame: at baseline: day 1
Clinical factors associated with transition in UHR: depression
Time frame: at baseline: day 1
Difference between three groups (NoP no psychosis, UHR and FEP first episode psychosis): insight scale
Time frame: at baseline: day 1
Difference between three groups (NoP, UHR and FEP): self-esteem.
Time frame: at baseline: day 1
Difference between three groups ((NoP, UHR and FEP): depression.
Time frame: at baseline: day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
Mirvat B HAMDAN-DUMONT, MD principal investigator
Hospital Esquirol Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of At-risk Mental States, run by Centre Hospitalier Esquirol 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 7 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 19 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Percent of Psychotic transition in UHR (time frame: 30 months). 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 19 Dec 2025.