Schizophrenia ProdromalLONGIPEPNCT05340348
Patientheque in Patients With a Psychosis
A study testing Blood samples (36 mL) + fecal samples + hair sample in people with Schizophrenia Prodromal and Schizophrenia, Childhood, run by University Hospital, Brest at 1 site in France.
Trial summary
Establishment of a patient library for patients who have had a first psychotic episode and who have an "at risk" status for psychotic disorder (GRD, APS, BLIPS group) or a psychosis threshold during CAARMS administration. Read more about this study
- Who is it for?
- Ages 15 to 30 years
- Conditions the study is for
- Schizophrenia Prodromal, Schizophrenia, Childhood, Schizophrenia
- What is being tested?
- Blood samples (36 mL) + fecal samples + hair sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jul 2022to 25 Jul 2032
- Phase
- Interventional
- 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
Who may be able to join
- Major and or minor aged 15 to 30 assessed within the CEVUP (Consultation for the Assessment of Psychological Vulnerability) and cared for at the psychiatry center as part of a first psychotic episode (Diagnosis CIM 10: F20 -F29 first hospitalization). These patients are referred by care and medico-social partners (general practitioners, school doctors, school nurses, educators, addictologists, psychiatrists
- "At risk" status for psychotic disorder (GRD, APS, BLIPS group) or psychosis threshold during the CAARMS test (psychometric scale for the assessment of psychotic symptoms)
- Consent of the patient or his legal guardian
Who cannot join
- History of psychosis for more than one year
- "Not at risk" status for psychotic disorder on the CAARMS (psychometric scale for the assessment of psychotic symptomatology)
- IQ<70 (WAIS)
- Neurological disorder or other health problem that may explain the disorders
- Refusal to participate - History of psychosis for more than one year
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Brest
Brest, 29609
Christophe LEMEY, 06 19 21 10 32, christophe.lemey@chu-brest.fr
Michel WALTER, 06 42 30 58 48, michel.walter@chu-brest.fr
About this study
Official title: Formation of a Patientheque in Patients With a Beginner Psychosis
Establishment of a patient library for patients who have had a first psychotic episode and who have an "at risk" status for psychotic disorder (GRD, APS, BLIPS group) or a psychosis threshold during CAARMS administration. Samples are taken on inclusion, at 2 years, and if relapse or significant clinical event within 5 years of inclusion, on 250 patients for 10 years.
Read the detailed description
The constitution of this patient library will include results of clinical tests carried out in current practice, neurocognitive tests, blood samples, audio recordings, clinical follow-up, urine samples, fecal samples, brain imaging, EEG.
- Being tested
- Blood samples (36 mL) + fecal samples + hair sample
- Keywords
- Schizophrenia, Patient library
- Medical subject headings
- Schizotypal Personality Disorder, Schizophrenia, Childhood, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples (36 mL) + fecal samples + hair sampleOther
Also called Patient library
Blood samples at inclusion, 2 years later and/or if relapse, fecal samples at inclusion and every years for 5 years, hair sample at inclusion
| Study group | Role | What they receive |
|---|---|---|
| Patient library | Other | All the patients are included in one arm. They will undergo various type of samples. Receives: Other: Blood samples (36 mL) + fecal samples + hair sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
CAARMS (Comprehensive assessment of at-risk mental states) score.
The test will determine the mental state of the patient :
- "Not at risk of psychosis"
- "At risk of psychosis"
- "Psychosis threshold exceeded"
It is organized into 7 clinical dimensions: 1) positive symptoms 2) cognitive changes: attention / concentration 3) emotional disturbance 4) negative symptoms 5) behavioral change 6) physical and motor changes 7) general psychopathology.
Each category is scored between 0 and 6 depending on the level of intensity, frequency and duration of each symptom.
In order to determine if a subject meets the UHR criteria for CAARMS, only the first category (positive symptoms) and its four subscales are used according to a scoring algorithm.
Measured: 5 years
Secondary outcomes (1)
CAARMS sub-assemblies
If the patient is classified at risk of psychosis, the test will classify this risk into one of the three following categories : trait and state risk factor group, APS (attenuated psychotic symptoms) group, BLIPS (Brief, Limited or Intermittent Psychotic Symptoms) group.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start25 Jul 2022
- Primary completion25 Jul 2032 (estimated)
- Study completion25 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia ProdromalStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Monocentric interventional study with minimal risks and constraints
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel WALTER, Principal investigator, CHRU BREST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340348
- Sponsor's protocol ID
- 29BRC20.0097
- Acronym
- LONGIPEP
- Status last verified
- Jun 2026
- First submitted
- 8 Mar 2022
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Formation of a Patientheque in Patients With a Beginner Psychosis
- ClinicalTrials.gov ID
- NCT05340348
- Acronym / sponsor ID
- LONGIPEP / 29BRC20.0097
- Keywords
- Schizophrenia, Patient library
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 25 Jul 2032 (estimated)
- Study completion
- 25 Jul 2032 (estimated)
- First posted
- 22 Apr 2022 (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.
Establishment of a patient library for patients who have had a first psychotic episode and who have an "at risk" status for psychotic disorder (GRD, APS, BLIPS group) or a psychosis threshold during CAARMS administration. Samples are taken on inclusion, at 2 years, and if relapse or significant clinical event within 5 years of inclusion, on 250 patients for 10 years.
Detailed description
The constitution of this patient library will include results of clinical tests carried out in current practice, neurocognitive tests, blood samples, audio recordings, clinical follow-up, urine samples, fecal samples, brain imaging, EEG.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Monocentric interventional study with minimal risks and constraints
| Arm | Type | Receives |
|---|---|---|
| Patient library | Other | Other: Blood samples (36 mL) + fecal samples + hair sampleAll the patients are included in one arm. They will undergo various type of samples. |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Major and or minor aged 15 to 30 assessed within the CEVUP (Consultation for the Assessment of Psychological Vulnerability) and cared for at the psychiatry center as part of a first psychotic episode (Diagnosis CIM 10: F20 -F29 first hospitalization). These patients are referred by care and medico-social partners (general practitioners, school doctors, school nurses, educators, addictologists, psychiatrists
- "At risk" status for psychotic disorder (GRD, APS, BLIPS group) or psychosis threshold during the CAARMS test (psychometric scale for the assessment of psychotic symptoms)
- Consent of the patient or his legal guardian
Key exclusion criteria (5 listed)
- History of psychosis for more than one year
- "Not at risk" status for psychotic disorder on the CAARMS (psychometric scale for the assessment of psychotic symptomatology)
- IQ<70 (WAIS)
- Neurological disorder or other health problem that may explain the disorders
- Refusal to participate - History of psychosis for more than one year
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 |
|---|---|---|
| Blood samples (36 mL) + fecal samples + hair sampleAlso: Patient libraryBlood samples at inclusion, 2 years later and/or if relapse, fecal samples at inclusion and every years for 5 years, hair sample at inclusion | Other | Patient library |
Primary outcome
CAARMS (Comprehensive assessment of at-risk mental states) score.
Time frame: 5 years
The test will determine the mental state of the patient : * "Not at risk of psychosis" * "At risk of psychosis" * "Psychosis threshold exceeded" It is organized into 7 clinical dimensions: 1) positive symptoms 2) cognitive changes: attention / concentration 3) emotional disturbance 4) negative symptoms 5) behavioral change 6) physical and motor changes 7) general psychopathology. Each category is scored between 0 and 6 depending on the level of intensity, frequency and duration of each symptom. In order to determine if a subject meets the UHR criteria for CAARMS, only the first category (positive symptoms) and its four subscales are used according to a scoring algorithm.
1 secondary outcome
CAARMS sub-assemblies
Time frame: 5 years
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 26 Jun 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
Michel WALTER principal investigator
CHRU BREST
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples (36 mL) + fecal samples + hair sample in people with Schizophrenia Prodromal and Schizophrenia, Childhood, run by University Hospital, Brest 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 26 Jun 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?
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?
Contact Michel WALTER (+332 98 01 51 56, michel.walter@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CAARMS (Comprehensive assessment of at-risk mental states) score. (time frame: 5 years). 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 26 Jun 2026.