SchizophreniaPSYDEVNCT04370730
Dimensional and Developmental Profiles of Psychosis in Children and Adolescents
A study testing clinical, neuroimaging and DNA assessments in people with Schizophrenia and Psychotic Disorders, run by Assistance Publique - Hôpitaux de Paris at 6 sites in France.
Trial summary
Five collaborating sites in France will study the broad spectrum of schizophrenia in children and adolescents. Patients will be studied with diagnostic interviews, developmental histories, dimensional clinical ratings, comprehensive cognitive assessments, neuroimaging and DNA (copy number variant) analyses (in… Read more about this study
- Who is it for?
- Ages 7 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Psychotic Disorders
- What is being tested?
- clinical, neuroimaging and DNA assessments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 6 sitesFrance
- Study dates
- 2 Jun 2021to 1 Oct 2026
- 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 7 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Children and young adults ages 7-20 years with age of onset of psychotic disorder between 7-17 years.
- Hospitalized or seen for out-patient treatment for a psychotic episode, acute or chronic.
- DSM-V diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, psychotic disorder not otherwise specified, or major depressive episode with psychotic features.
- Written informed consent signed by the parents or the individual(s) with legal parental authority, and by the minor patient if his/her condition permits.
- Written informed consent signed by the patient if he/she is a major, after clinical stabilization (not delusional).
- Has health insurance coverage from Social Security (France) (not AME coverage).
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- Inclusion Criteria for parents or siblings wishing to participate in the genetic part of the study :
- Parents : no specific criteria.
- Siblings : siblings are eligible to participate if there are at least two first-degree relatives with psychotic disorders (including the patient) in the family.
- Written informed consent for the genetic part of the study signed by any participating parents and siblings.
- Has health insurance coverage from Social Security (France) (not AME coverage).
Who cannot join
- Moderate or severe intellectual deficiency (IQ < 50).
- Psychoses judged to be secondary to medical illness, medication effects or drugs of abuse.
- Diagnosis of bipolar disorder.
- Patients who are under legal guardianship.
- For the neuroimaging part of the study only : any contraindications to Magnetic Resonance Imaging.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites, 6 recruiting
- Not yet recruiting
Fondation Vallée, Gentilly
Gentilly, 94257
BISSERY Anne, 01 42 16 24 32, anne.bissery@aphp.fr
JOUSSELME Catherine
- Not yet recruiting
CHRU de Lille
Lille, 59037
Bissery Anne, 01 42 16 24 32, anne.bissery@aphp.fr
JARDRI Renaud
- Not yet recruiting
CHU de Nice
Nice, 62000
BISSERY Anne, 01 42 16 24 32, anne.bissery@aphp.fr
ASKENAZY Florence
- Recruiting
Pitié Salpétrière
Paris, 75013
BISSERY Anne, 01 42 16 24 32, anne.bissery@aphp.fr
LAURENT-LEVINSON Claudine, M.D., Ph.D.
- Not yet recruiting
CHU de Rouen
Rouen, 76031
BISSERY Anne, 01 42 16 24 32, anne.bissery@aphp.fr
GERARDIN Priscile
- Not yet recruiting
CHU de Rouvray
Rouen, 76031
BISSERY Anne, 01 42 16 24 32, anne.bissery@aphp.fr
GERARDIN Priscile
About this study
Official title: Dimensional and Developmental Approach to Psychotic Episodes in Children and Adolescents: Impact on Clinical Management
Five collaborating sites in France will study the broad spectrum of schizophrenia in children and adolescents. Patients will be studied with diagnostic interviews, developmental histories, dimensional clinical ratings, comprehensive cognitive assessments, neuroimaging and DNA (copy number variant) analyses (in families and patients who agree), and follow-up of course of illness, cognitive status and treatment response to specific antipsychotic drugs. The goal of the study is to test a prior hypothesis about clinical subgroups in this population and to test whether these subgroups predict antipsychotic medication response.
Read the detailed description
This study relates to the organization of a collection of clinical, biological / genetic and radiological (MRI) data from people with a psychotic episode and from their families. These data will be analyzed to clarify whether there is a different response to antipsychotic treatment based on developmental and clinical expression.To answer the question asked in the research, it is planned to include people with at least one psychotic episode,The target population will be a prospective cohort of patients admitted to a hospital or psychiatric clinic for the treatment of psychotic symptoms.Comprehensive medical evaluation will be carried out according to the clinical features and medical history of each patient, to identify medical causes of psychosis. Comprehensive neuropsychological and speech / language evaluation will be completed. A child psychiatrist-diagnostician will complete the Lifetime Dimensions of Psychosis Scale - Child and Adolescent version at baseline. When the patient and parents agree, structural and functional MRI examinations will also be completed, and blood will be drawn for DNA extraction and analysis. Selected assessments (including evaluation of treatment response to specific antipsychotic drugs) will be performed at follow-up visits after 1, 3 and 5 years.
- Conditions
- Schizophrenia, Psychotic Disorders
- Being tested
- clinical, neuroimaging and DNA assessments
- Keywords
- schizophrenia, schizophrenia spectrum, psychosis, early-onset, cognition, magnetic resonance imaging, course of illness, treatment response
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical, neuroimaging and DNA assessmentsOther
Selected assessments, including evaluation of treatment response to specific antipsychotic drugs, will be performed at follow-up visits after 1, 3 and 5 years
| Study group | Role | What they receive |
|---|---|---|
| prospective cohort | Other | prospective monitoring of children and adolescents with schizophrenia and related psychotic disorders Receives: Other: clinical, neuroimaging and DNA assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lifetime Dimensions of Psychosis Scale-Child and Adolescent Version
Symptoms are rated for lifetime duration and for severity during the worst two-week period.
Number of participants assigned to each of four clinical clusters derived by cluster analysis from clinical and developmental ratings on this scale as previously described.
Measured: 4 months
Secondary outcomes (3)
Clinical global impressions scale - change version
score on a 7 point scale ; worse is 7
Measured: at 5 years
Cortical gray matter volume (Magnetic Resonance Imaging)
Statistical differences among the four clinical clusters in the summary measure of cortical gray matter volume
Measured: up to 4 months
Stability of clinical profile on Lifetime Dimensions of Psychosis Scale-Child and Adolescent Version
differences among the four clinical clusters over time, comparing the cluster assignment at the time of stabilization to the assignment at the last study visit
Measured: at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start2 Jun 2021
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (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 Assistance Publique - Hôpitaux de ParisThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- prospective cohort study
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudine LAURENT-LEVINSON, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04370730
- Sponsor's protocol ID
- K160906J
- Other IDs
- 2018-A01072-53
- Acronym
- PSYDEV
- Status last verified
- Jan 2025
- First submitted
- 25 Mar 2020
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dimensional and Developmental Approach to Psychotic Episodes in Children and Adolescents: Impact on Clinical Management
- ClinicalTrials.gov ID
- NCT04370730
- Acronym / sponsor ID
- PSYDEV / K160906J
- Conditions
- Schizophrenia, Psychotic Disorders
- Keywords
- schizophrenia, schizophrenia spectrum, psychosis, early-onset, cognition, magnetic resonance imaging, course of illness, treatment response
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 1 May 2020 (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.
Five collaborating sites in France will study the broad spectrum of schizophrenia in children and adolescents. Patients will be studied with diagnostic interviews, developmental histories, dimensional clinical ratings, comprehensive cognitive assessments, neuroimaging and DNA (copy number variant) analyses (in families and patients who agree), and follow-up of course of illness, cognitive status and treatment response to specific antipsychotic drugs. The goal of the study is to test a prior hypothesis about clinical subgroups in this population and to test whether these subgroups predict antipsychotic medication response.
Detailed description
This study relates to the organization of a collection of clinical, biological / genetic and radiological (MRI) data from people with a psychotic episode and from their families. These data will be analyzed to clarify whether there is a different response to antipsychotic treatment based on developmental and clinical expression.To answer the question asked in the research, it is planned to include people with at least one psychotic episode,The target population will be a prospective cohort of patients admitted to a hospital or psychiatric clinic for the treatment of psychotic symptoms.Comprehensive medical evaluation will be carried out according to the clinical features and medical history of each patient, to identify medical causes of psychosis. Comprehensive neuropsychological and speech / language evaluation will be completed. A child psychiatrist-diagnostician will complete the Lifetime Dimensions of Psychosis Scale - Child and Adolescent version at baseline. When the patient and parents agree, structural and functional MRI examinations will also be completed, and blood will be drawn for DNA extraction and analysis. Selected assessments (including evaluation of treatment response to specific antipsychotic drugs) will be performed at follow-up visits after 1, 3 and 5 years.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| prospective cohort | Other | Other: clinical, neuroimaging and DNA assessmentsprospective monitoring of children and adolescents with schizophrenia and related psychotic disorders |
Who may qualify
- Ages
- 7 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Children and young adults ages 7-20 years with age of onset of psychotic disorder between 7-17 years.
- Hospitalized or seen for out-patient treatment for a psychotic episode, acute or chronic.
- DSM-V diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, psychotic disorder not otherwise specified, or major depressive episode with psychotic features.
- Written informed consent signed by the parents or the individual(s) with legal parental authority, and by the minor patient if his/her condition permits.
- Written informed consent signed by the patient if he/she is a major, after clinical stabilization (not delusional).
Key exclusion criteria (5 listed)
- Moderate or severe intellectual deficiency (IQ < 50).
- Psychoses judged to be secondary to medical illness, medication effects or drugs of abuse.
- Diagnosis of bipolar disorder.
- Patients who are under legal guardianship.
- For the neuroimaging part of the study only : any contraindications to Magnetic Resonance Imaging.
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 |
|---|---|---|
| clinical, neuroimaging and DNA assessmentsSelected assessments, including evaluation of treatment response to specific antipsychotic drugs, will be performed at follow-up visits after 1, 3 and 5 years | Other | prospective cohort |
Primary outcome
Lifetime Dimensions of Psychosis Scale-Child and Adolescent Version
Time frame: 4 months
Symptoms are rated for lifetime duration and for severity during the worst two-week period. Number of participants assigned to each of four clinical clusters derived by cluster analysis from clinical and developmental ratings on this scale as previously described.
3 secondary outcomes
Clinical global impressions scale - change version
Time frame: at 5 years
Cortical gray matter volume (Magnetic Resonance Imaging)
Time frame: up to 4 months
Stability of clinical profile on Lifetime Dimensions of Psychosis Scale-Child and Adolescent Version
Time frame: at 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 23 Jan 2026.
- 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.
Claudine LAURENT-LEVINSON study director
Assistance Publique - Hôpitaux de Paris
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clinical, neuroimaging and DNA assessments in people with Schizophrenia and Psychotic Disorders, run by Assistance Publique - Hôpitaux de Paris at 6 sites 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 11 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 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 Claudine LAURENT-LEVINSON, M.D., Ph.D. (1 42 16 23 44 ext. +33, claudine.laurent@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lifetime Dimensions of Psychosis Scale-Child and Adolescent Version (time frame: 4 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 23 Jan 2026.