Dimensional and Developmental Profiles of Psychosis in Children and Adolescents (PSYDEV)
Primary Purpose
Schizophrenia, Psychotic Disorders
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
clinical, neuroimaging and DNA assessments
Sponsored by
About this trial
This is an interventional other trial for Schizophrenia focused on measuring schizophrenia, schizophrenia spectrum, psychosis, early-onset, cognition, magnetic resonance imaging, course of illness, treatment response
Eligibility Criteria
Inclusion Criteria for the Patient:
- 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).
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).
Exclusion Criteria:
- 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.
Sites / Locations
- Fondation Vallée, Gentilly
- CHRU de Lille
- CHU de Nice
- Pitié SalpétrièreRecruiting
- CHU de Rouen
- CHU de Rouvray
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
prospective cohort
Arm Description
prospective monitoring of children and adolescents with schizophrenia and related psychotic disorders
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Clinical global impressions scale - change version
score on a 7 point scale ; worse is 7
Cortical gray matter volume (Magnetic Resonance Imaging)
Statistical differences among the four clinical clusters in the summary measure of cortical gray matter volume
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
Full Information
NCT ID
NCT04370730
First Posted
March 25, 2020
Last Updated
December 6, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT04370730
Brief Title
Dimensional and Developmental Profiles of Psychosis in Children and Adolescents
Acronym
PSYDEV
Official Title
Dimensional and Developmental Approach to Psychotic Episodes in Children and Adolescents: Impact on Clinical Management
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 2, 2021 (Actual)
Primary Completion Date
March 31, 2026 (Anticipated)
Study Completion Date
March 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Psychotic Disorders
Keywords
schizophrenia, schizophrenia spectrum, psychosis, early-onset, cognition, magnetic resonance imaging, course of illness, treatment response
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
prospective cohort study
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
prospective cohort
Arm Type
Other
Arm Description
prospective monitoring of children and adolescents with schizophrenia and related psychotic disorders
Intervention Type
Other
Intervention Name(s)
clinical, neuroimaging and DNA assessments
Intervention Description
Selected assessments, including evaluation of treatment response to specific antipsychotic drugs, will be performed at follow-up visits after 1, 3 and 5 years
Primary Outcome Measure Information:
Title
Lifetime Dimensions of Psychosis Scale-Child and Adolescent Version
Description
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.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Clinical global impressions scale - change version
Description
score on a 7 point scale ; worse is 7
Time Frame
at 5 years
Title
Cortical gray matter volume (Magnetic Resonance Imaging)
Description
Statistical differences among the four clinical clusters in the summary measure of cortical gray matter volume
Time Frame
up to 4 months
Title
Stability of clinical profile on Lifetime Dimensions of Psychosis Scale-Child and Adolescent Version
Description
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
Time Frame
at 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for the Patient:
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).
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).
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claudine LAURENT-LEVINSON, M.D., Ph.D.
Phone
1 42 16 23 44
Ext
+33
Email
claudine.laurent@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Anne BISSERY
Phone
1 42 16 34 32
Ext
+33
Email
anne.bissery@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudine LAURENT-LEVINSON
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Director
Facility Information:
Facility Name
Fondation Vallée, Gentilly
City
Gentilly
ZIP/Postal Code
94257
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BISSERY Anne
Phone
01 42 16 24 32
Email
anne.bissery@aphp.fr
First Name & Middle Initial & Last Name & Degree
JOUSSELME Catherine
Facility Name
CHRU de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bissery Anne
Phone
01 42 16 24 32
Email
anne.bissery@aphp.fr
First Name & Middle Initial & Last Name & Degree
JARDRI Renaud
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
62000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BISSERY Anne
Phone
01 42 16 24 32
Email
anne.bissery@aphp.fr
First Name & Middle Initial & Last Name & Degree
ASKENAZY Florence
Facility Name
Pitié Salpétrière
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BISSERY Anne
Phone
01 42 16 24 32
Email
anne.bissery@aphp.fr
First Name & Middle Initial & Last Name & Degree
LAURENT-LEVINSON Claudine, M.D., Ph.D.
Facility Name
CHU de Rouen
City
Rouen
ZIP/Postal Code
76031
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BISSERY Anne
Phone
01 42 16 24 32
Email
anne.bissery@aphp.fr
First Name & Middle Initial & Last Name & Degree
GERARDIN Priscile
Facility Name
CHU de Rouvray
City
Rouen
ZIP/Postal Code
76031
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BISSERY Anne
Phone
01 42 16 24 32
Email
anne.bissery@aphp.fr
First Name & Middle Initial & Last Name & Degree
GERARDIN Priscile
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Dimensional and Developmental Profiles of Psychosis in Children and Adolescents
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