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Evaluation of the Impact of Case Manager Intervention on the 3-year Psychotic Episode Recurrence Rate in Patients Aged 16 to 30 Years With a First Psychotic Episode. (PEPsy-CM)

Primary Purpose

Psychotic Episode

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Case management
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotic Episode

Eligibility Criteria

16 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The patient or their close relative must have given their free and informed consent and signed the consent form
  • The patient must be a member or beneficiary of a health insurance plan
  • The patient is available for a 3-year follow-up.
  • Patient is managed in a psychiatric service (consultation or hospitalization) for a first episode psychosis defined by:

    • Presence of positive psychotic symptoms (delusion(s) and/or hallucination(s) and/or conceptual disorganization) evolving for at least one week, either daily or at least 3 times per week for at least one hour per occasion ;
    • Never having taken a neuroleptic treatment with antipsychotic aim (except for an antipsychotic treatment started for the current episode for example by the general practitioner before being referred to psychiatry);
    • A disorder meeting the DSM 5 criteria from the following list: delusional disorder, brief psychotic disorder greater than 7 days, schizophreniform disorder, schizophrenia, schizoaffective disorder, substance-induced psychotic disorder greater than 7 days, other specific or nonspecific schizophrenic spectrum disorder or other psychotic disorder, bipolar I or II disorder with congruent and non-mood congruent psychotic features, bipolar disorder with congruent and non-mood congruent psychotic features induced by a substance, major depressive disorder with congruent and non-mood congruent psychotic features.
  • Inclusion should be within the first 3 months of care for first episode psychosis in the psychiatric service.
  • At the time of inclusion, the psychotic symptomatology observed during the first episode psychosis may still be present or in remission.

Exclusion Criteria:

  • The subject is participating in another category I interventional study, or is in a period of exclusion determined by a previous study
  • The subject, or one of the parents for minor patients, refuses to sign the consent
  • It is impossible to give the subject informed information
  • The patient is under safeguard of justice or state guardianship
  • The patients has an IQ less than or equal to 55
  • The patient has a first psychotic episode linked to a psychotic problem triggered by a medication of other medical condition
  • The patient is pregnant or breastfeeding

Sites / Locations

  • CHU de TOULOUSE
  • CH Saint Marie Clermont-Ferrand
  • CHU de MontpellierRecruiting
  • CHU Nice
  • CHU de NîmesRecruiting
  • Centre Hospitalier Léon-Jean GrégoryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Case manager group

Control

Arm Description

Outcomes

Primary Outcome Measures

Rate of patients with recurrence of psychotic episode at least once between groups
Recurrence of the psychotic episode will be defined as psychiatric hospitalization with a diagnosis of psychotic disorder and/or the presence of positive psychotic symptoms according to the Positive and Negative Symptom Scale (PANSS) ≥ 4 for item P1 (delusions) and/or P2 (conceptual disorganization) and/or P3 (hallucination)) over a period of at least one week.

Secondary Outcome Measures

Evaluate the impact of the intervention on the number of recurrences of psychiatric hospitalization per patient
number
Evaluate the impact of the intervention on the number of recurrences of psychiatric hospitalization per patient
number
Evaluate the impact of the intervention on the number of recurrences of psychiatric hospitalization per patient
number
Evaluate the impact of the intervention on the number of psychiatric hospitalizations per patient
number
Evaluate the impact of the intervention on the number of psychiatric hospitalizations per patient
number
Evaluate the impact of the intervention on the number of psychiatric hospitalizations per patient
number
Evaluate the impact of the intervention on the duration of psychiatric hospitalization per patient
days/weeks/months
Evaluate the impact of the intervention on the duration of psychiatric hospitalization per patient
days/weeks/months
Evaluate the impact of the intervention on the duration of psychiatric hospitalization per patient
days/weeks/months
Percentage per patient of medical and caregiving appointments honored between groups
Percentage per patient of medical and caregiving appointments honored between groups
Percentage per patient of medical and caregiving appointments honored between groups
Percentage per patient of medical and caregiving appointments honored between groups
Percentage per patient of medical and caregiving appointments honored between groups
Percentage per patient of medical and caregiving appointments honored between groups
Percentage per patient of medical and caregiving appointments honored between groups
Type of hospital admission (voluntary versus involuntary) between groups
% voluntary versus involuntary
Type of hospital admission (voluntary versus involuntary) between groups
% voluntary versus involuntary
Type of hospital admission (voluntary versus involuntary) between groups
% voluntary versus involuntary
Type of hospital admission (voluntary versus involuntary) between groups
% voluntary versus involuntary
Type of hospital admission (voluntary versus involuntary) between groups
% voluntary versus involuntary
Type of hospital admission (voluntary versus involuntary) between groups
% voluntary versus involuntary
Type of hospital admission (voluntary versus involuntary) between groups
% voluntary versus involuntary
Unscheduled discharge from care between groups
Defined by a break in follow-up organized by the referring care team for more than 30 days
Unscheduled discharge from care between groups
Defined by a break in follow-up organized by the referring care team for more than 30 days
Unscheduled discharge from care between groups
Defined by a break in follow-up organized by the referring care team for more than 30 days
Unscheduled discharge from care between groups
Defined by a break in follow-up organized by the referring care team for more than 30 days
Unscheduled discharge from care between groups
Defined by a break in follow-up organized by the referring care team for more than 30 days
Unscheduled discharge from care between groups
Defined by a break in follow-up organized by the referring care team for more than 30 days
Unscheduled discharge from care between groups
Defined by a break in follow-up organized by the referring care team for more than 30 days
Treatment compliance between groups
item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)
Treatment compliance between groups
item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)
Treatment compliance between groups
item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)
Treatment compliance between groups
item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)
Treatment compliance between groups
item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)
Treatment compliance between groups
item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)
Treatment compliance between groups
item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)
Adherence to treatment
Medication Adherence Rating Scale (MARS, self-administered questionnaire)
Adherence to treatment
Medication Adherence Rating Scale (MARS, self-administered questionnaire)
Adherence to treatment
Medication Adherence Rating Scale (MARS, self-administered questionnaire)
Therapeutic alliance
Working Alliance Inventory-Short Revised (WAI-SR, self-administered questionnaire)
Therapeutic alliance
Working Alliance Inventory-Short Revised (WAI-SR, self-administered questionnaire)
Therapeutic alliance
Working Alliance Inventory-Short Revised (WAI-SR, self-administered questionnaire)
Patient awareness of disorders and of the need for treatment
Birchwood Insight Scale (BIS, self-administered questionnaire)
Patient awareness of disorders and of the need for treatment
Birchwood Insight Scale (BIS, self-administered questionnaire)
Patient awareness of disorders and of the need for treatment
Birchwood Insight Scale (BIS, self-administered questionnaire)
Assessment of addictive comorbidities
semi-structured clinical interview for DSM (SCID)
Assessment of addictive comorbidities
semi-structured clinical interview for DSM (SCID)
Assessment of tobacco, alcohol and drug use
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Evaluation of the clinical impact of the intervention between groups
Clinical Global Impression questionnaire (CGI)
Psychotic and general symptoms
Positive and Negative Symptom Scale (PANSS)
Depressive symptoms
Calgary Depression Scale for Schizophrenia (CDSS)
Self- and hetero-aggressive behaviors
according to Health of the Nation Outcome Scales (HoNOS) items 1 and 2
Reported adverse events
death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS
Reported adverse events
death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS
Reported adverse events
death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS
Reported adverse events
death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS
Reported adverse events
death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS
Reported adverse events
death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS
Reported adverse events
death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS
Current suicidal ideations
Calgary Depression Scale for Schizophrenia (CDSS)
Current suicidal ideations
Calgary Depression Scale for Schizophrenia (CDSS)
Current suicidal ideations
Calgary Depression Scale for Schizophrenia (CDSS)
Current suicidal ideations
Calgary Depression Scale for Schizophrenia (CDSS)
Current suicidal ideations
Calgary Depression Scale for Schizophrenia (CDSS)
Current suicidal ideations
Calgary Depression Scale for Schizophrenia (CDSS)
Current suicidal ideations
Calgary Depression Scale for Schizophrenia (CDSS)
Assess the impact of the intervention on socio-professional functioning and quality of life
Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation
Assess the impact of the intervention on socio-professional functioning and quality of life
Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation
Assess the impact of the intervention on socio-professional functioning and quality of life
Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation
Assess the impact of the intervention on socio-professional functioning and quality of life
Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation
Assess the impact of the intervention on socio-professional functioning and quality of life
Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation
Assess the impact of the intervention on socio-professional functioning and quality of life
Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation
Assess the impact of the intervention on socio-professional functioning and quality of life
Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation
Social and occupational functioning
Social and Occupational Functioning Assessment Scale (SOFAS)
Social and occupational functioning
Social and Occupational Functioning Assessment Scale (SOFAS)
Social and occupational functioning
Social and Occupational Functioning Assessment Scale (SOFAS)
Social and occupational functioning
Social and Occupational Functioning Assessment Scale (SOFAS)
Social and occupational functioning
Social and Occupational Functioning Assessment Scale (SOFAS)
Social and occupational functioning
Social and Occupational Functioning Assessment Scale (SOFAS)
Social and occupational functioning
Social and Occupational Functioning Assessment Scale (SOFAS)
Social functioning
Health of the Nation Outcome Scales
Social functioning
Health of the Nation Outcome Scales
Social functioning
Health of the Nation Outcome Scales
Social functioning
Health of the Nation Outcome Scales
Social functioning
Health of the Nation Outcome Scales
Social functioning
Health of the Nation Outcome Scales
Social functioning
Health of the Nation Outcome Scales
Psychosocial functioning
Quality of Life Scale (QLS) - semi-structured interview
Psychosocial functioning
Quality of Life Scale (QLS) - semi-structured interview
Psychosocial functioning
Quality of Life Scale (QLS) - semi-structured interview
Psychosocial functioning
Quality of Life Scale (QLS) - semi-structured interview
Psychosocial functioning
Quality of Life Scale (QLS) - semi-structured interview
Psychosocial functioning
Quality of Life Scale (QLS) - semi-structured interview
Psychosocial functioning
Quality of Life Scale (QLS) - semi-structured interview
Functioning
Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire
Functioning
Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire
Functioning
Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire
Functioning
Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire
Functioning
Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire
Functioning
Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire
Functioning
Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire
Quality of life of users (patient and family)
World Health Organization Quality of Life brief (WHOQOL-brief)
Quality of life of users (patient and family)
World Health Organization Quality of Life brief (WHOQOL-brief)
Quality of life of users (patient and family)
World Health Organization Quality of Life brief (WHOQOL-brief)
Health-related quality of life
EuroQol-5D 3 level version (EQ-5D-35L)
Health-related quality of life
EuroQol-5D 3 level version (EQ-5D-35L)
Health-related quality of life
EuroQol-5D 3 level version (EQ-5D-35L)
Quality of life of relatives
caregiver schizophrenia quality of life questionnaire (S-CGQoL)
Quality of life of relatives
caregiver schizophrenia quality of life questionnaire (S-CGQoL)
Quality of life of relatives
caregiver schizophrenia quality of life questionnaire (S-CGQoL)
Cost-outcome type ratio
the ratio of the difference in costs between the two strategies divided by the difference in QALYs. This ratio measures the cost per life-year gained in full health, i.e. a cost per QALY. This indicator is obtained by weighting the time spent in each health state h by the utility of that health state measured by the EQ-5D
Cost of care
assessed from a community perspective (health care system, out-of-pocket expenses, caregivers)
Budget impact analysis between strategies
National estimates of avoided costs, care consumption and the cost of implementing the system in the two management strategies
Psychiatric assessment
Structured Clinical Interview for DSM
Psychiatric assessment
Structured Clinical Interview for DSM
Patient age
Patient sex
Current patient professional/training situation
working or studying
Financial situation
Care pathways taken by patient
specialist care sought
Duration of non-treated psychosis
Interval between start of psychotic symptoms and start of sufficient antipsychotic treatment
Personal and family psychiatric history
Social and academic function
Premorbid Adjustment Scale
Medical treatment received
Cerebral imagery
Normal/abnormal
Cerebral imagery
Normal/abnormal
Cerebral imagery
Normal/abnormal
IQ profile
Homogenous/heterogenous
IQ profile
Homogenous/heterogenous
IQ profile
Homogenous/heterogenous
IQ
value
IQ
value
IQ
value
BMI
kg/m2
BMI
kg/m2
BMI
kg/m2
Fasting glycemia
mmol/l
Fasting glycemia
mmol/l
Fasting glycemia
mmol/l
Lipid assessment
Normal/abnormal
Lipid assessment
Normal/abnormal
Lipid assessment
Normal/abnormal
Whole blood count
Normal/abnormal
Whole blood count
Normal/abnormal
Whole blood count
Normal/abnormal
Electrolytes
Normal/abnormal
Electrolytes
Normal/abnormal
Electrolytes
Normal/abnormal
Neurological exam
Normal/abnormal
Neurological exam
Normal/abnormal
Neurological exam
Normal/abnormal
Cardiovascular exam
Normal/abnormal
Cardiovascular exam
Normal/abnormal
Cardiovascular exam
Normal/abnormal
Morphological exam
Normal/abnormal
Morphological exam
Normal/abnormal
Morphological exam
Normal/abnormal
Hepatic exam
Normal/abnormal
Hepatic exam
Normal/abnormal
Hepatic exam
Normal/abnormal
Presence of neurometabolic disease
Yes/no
Presence of neurometabolic disease
Yes/no
Presence of neurometabolic disease
Yes/no
Electrocardiogram
Normal/abnormal
Electrocardiogram
Normal/abnormal
Electrocardiogram
Normal/abnormal
C-reactive protein
mg/l
C-reactive protein
mg/l
C-reactive protein
mg/l
thyroid-stimulating hormone
mUI/l
thyroid-stimulating hormone
mUI/l
thyroid-stimulating hormone
mUI/l
Cortisol
nmol/l
Cortisol
nmol/l
Cortisol
nmol/l
Adverse events
Any of the following (yes/no): Neurological symptoms, overweight, metabolic syndrome, sexual dysfunction, fatigue, salivation dysfunction, other
Adverse events
Any of the following (yes/no): Neurological symptoms, overweight, metabolic syndrome, sexual dysfunction, fatigue, salivation dysfunction, other
Adverse events
Any of the following (yes/no): Neurological symptoms, overweight, metabolic syndrome, sexual dysfunction, fatigue, salivation dysfunction, other
Non-medical treatment received
Psychosocial/psychotherapy interventions
In the experimental group: case management according to good practice guidelines
EPPIC Model Integrity Tool (80 items with subscores)
In the experimental group: Conformity of case management
Index of Fidelity to Assertive Community Treatment (16 criteria of conformity for three dimensions)
In the experimental group: conformity to TIDieR checklist in each patient
TIDieR checklist-patient
In the experimental group: conformity to TIDieR checklist in each patient
TIDieR checklist-patient
In the experimental group: conformity to TIDieR checklist in each patient
TIDieR checklist-patient
In the experimental group: conformity to TIDieR checklist in each patient
TIDieR checklist-patient
In the experimental group: conformity to TIDieR checklist in each patient
TIDieR checklist-patient
In the experimental group: conformity to TIDieR checklist in each patient
TIDieR checklist-patient
In the experimental group: conformity to TIDieR checklist in each patient
TIDieR checklist-patient
In the experimental group: conformity to TIDieR checklist in each center
Customized TIDieR checklist-center
Satisfaction of patients and their families
Client Satisfaction Questionnaire (CSQ)-8
Satisfaction of patients and their families
Client Satisfaction Questionnaire (CSQ)-8
Satisfaction of patients and their families
Client Satisfaction Questionnaire (CSQ)-8
Satisfaction of participants receiving help from a health coordinator
7-item custom questionnaire with free answer section

Full Information

First Posted
October 5, 2021
Last Updated
July 13, 2023
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT05116514
Brief Title
Evaluation of the Impact of Case Manager Intervention on the 3-year Psychotic Episode Recurrence Rate in Patients Aged 16 to 30 Years With a First Psychotic Episode.
Acronym
PEPsy-CM
Official Title
Evaluation of the Impact of Case Manager Intervention on the 3-year Psychotic Episode Recurrence Rate in Patients Aged 16 to 30 Years With a First Psychotic Episode. Randomized, Open-label, Multicenter Controlled Study With Blinded Evaluation.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 27, 2021 (Actual)
Primary Completion Date
September 2028 (Anticipated)
Study Completion Date
November 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The study investigators hypothesize that the intervention of case managers specifically trained in case management of early psychosis will change the paradigm of care of a first psychotic episode from the current organization of the care system. Indeed, the creation of specific services for emerging psychotic disorders cannot easily be generalized throughout the country and requires specific funding. The intervention of case managers according to the recommendations of good practices will make it possible to propose the fundamental principles of early intervention to young patients and their families on a large scale throughout the territory, namely: personalized and proactive accompaniment, psycho-education of the pathology and treatments, involvement and support of the families, and support for socio-professional reintegration

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Episode

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
256 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Case manager group
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Case management
Intervention Description
Regular and personalized follow-up by a case manager using a "case management" approach, updated every 3 months
Primary Outcome Measure Information:
Title
Rate of patients with recurrence of psychotic episode at least once between groups
Description
Recurrence of the psychotic episode will be defined as psychiatric hospitalization with a diagnosis of psychotic disorder and/or the presence of positive psychotic symptoms according to the Positive and Negative Symptom Scale (PANSS) ≥ 4 for item P1 (delusions) and/or P2 (conceptual disorganization) and/or P3 (hallucination)) over a period of at least one week.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Evaluate the impact of the intervention on the number of recurrences of psychiatric hospitalization per patient
Description
number
Time Frame
1 year
Title
Evaluate the impact of the intervention on the number of recurrences of psychiatric hospitalization per patient
Description
number
Time Frame
2 years
Title
Evaluate the impact of the intervention on the number of recurrences of psychiatric hospitalization per patient
Description
number
Time Frame
3 years
Title
Evaluate the impact of the intervention on the number of psychiatric hospitalizations per patient
Description
number
Time Frame
1 year
Title
Evaluate the impact of the intervention on the number of psychiatric hospitalizations per patient
Description
number
Time Frame
2 years
Title
Evaluate the impact of the intervention on the number of psychiatric hospitalizations per patient
Description
number
Time Frame
3 years
Title
Evaluate the impact of the intervention on the duration of psychiatric hospitalization per patient
Description
days/weeks/months
Time Frame
1 year
Title
Evaluate the impact of the intervention on the duration of psychiatric hospitalization per patient
Description
days/weeks/months
Time Frame
2 years
Title
Evaluate the impact of the intervention on the duration of psychiatric hospitalization per patient
Description
days/weeks/months
Time Frame
3 years
Title
Percentage per patient of medical and caregiving appointments honored between groups
Time Frame
Inclusion
Title
Percentage per patient of medical and caregiving appointments honored between groups
Time Frame
6 months
Title
Percentage per patient of medical and caregiving appointments honored between groups
Time Frame
1 year
Title
Percentage per patient of medical and caregiving appointments honored between groups
Time Frame
18 months
Title
Percentage per patient of medical and caregiving appointments honored between groups
Time Frame
2 years
Title
Percentage per patient of medical and caregiving appointments honored between groups
Time Frame
2.5 years
Title
Percentage per patient of medical and caregiving appointments honored between groups
Time Frame
3 years
Title
Type of hospital admission (voluntary versus involuntary) between groups
Description
% voluntary versus involuntary
Time Frame
Inclusion
Title
Type of hospital admission (voluntary versus involuntary) between groups
Description
% voluntary versus involuntary
Time Frame
6 months
Title
Type of hospital admission (voluntary versus involuntary) between groups
Description
% voluntary versus involuntary
Time Frame
1 year
Title
Type of hospital admission (voluntary versus involuntary) between groups
Description
% voluntary versus involuntary
Time Frame
18 months
Title
Type of hospital admission (voluntary versus involuntary) between groups
Description
% voluntary versus involuntary
Time Frame
2 years
Title
Type of hospital admission (voluntary versus involuntary) between groups
Description
% voluntary versus involuntary
Time Frame
2.5 years
Title
Type of hospital admission (voluntary versus involuntary) between groups
Description
% voluntary versus involuntary
Time Frame
3 years
Title
Unscheduled discharge from care between groups
Description
Defined by a break in follow-up organized by the referring care team for more than 30 days
Time Frame
Inclusion
Title
Unscheduled discharge from care between groups
Description
Defined by a break in follow-up organized by the referring care team for more than 30 days
Time Frame
6 months
Title
Unscheduled discharge from care between groups
Description
Defined by a break in follow-up organized by the referring care team for more than 30 days
Time Frame
1 year
Title
Unscheduled discharge from care between groups
Description
Defined by a break in follow-up organized by the referring care team for more than 30 days
Time Frame
18 months
Title
Unscheduled discharge from care between groups
Description
Defined by a break in follow-up organized by the referring care team for more than 30 days
Time Frame
2 years
Title
Unscheduled discharge from care between groups
Description
Defined by a break in follow-up organized by the referring care team for more than 30 days
Time Frame
2.5 years
Title
Unscheduled discharge from care between groups
Description
Defined by a break in follow-up organized by the referring care team for more than 30 days
Time Frame
3 years
Title
Treatment compliance between groups
Description
item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)
Time Frame
Inclusion
Title
Treatment compliance between groups
Description
item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)
Time Frame
6 months
Title
Treatment compliance between groups
Description
item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)
Time Frame
1 year
Title
Treatment compliance between groups
Description
item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)
Time Frame
18 months
Title
Treatment compliance between groups
Description
item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)
Time Frame
2 years
Title
Treatment compliance between groups
Description
item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)
Time Frame
2.5 years
Title
Treatment compliance between groups
Description
item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)
Time Frame
3 years
Title
Adherence to treatment
Description
Medication Adherence Rating Scale (MARS, self-administered questionnaire)
Time Frame
1 year
Title
Adherence to treatment
Description
Medication Adherence Rating Scale (MARS, self-administered questionnaire)
Time Frame
2 years
Title
Adherence to treatment
Description
Medication Adherence Rating Scale (MARS, self-administered questionnaire)
Time Frame
3 years
Title
Therapeutic alliance
Description
Working Alliance Inventory-Short Revised (WAI-SR, self-administered questionnaire)
Time Frame
1 year
Title
Therapeutic alliance
Description
Working Alliance Inventory-Short Revised (WAI-SR, self-administered questionnaire)
Time Frame
2 years
Title
Therapeutic alliance
Description
Working Alliance Inventory-Short Revised (WAI-SR, self-administered questionnaire)
Time Frame
3 years
Title
Patient awareness of disorders and of the need for treatment
Description
Birchwood Insight Scale (BIS, self-administered questionnaire)
Time Frame
1 year
Title
Patient awareness of disorders and of the need for treatment
Description
Birchwood Insight Scale (BIS, self-administered questionnaire)
Time Frame
2 years
Title
Patient awareness of disorders and of the need for treatment
Description
Birchwood Insight Scale (BIS, self-administered questionnaire)
Time Frame
3 years
Title
Assessment of addictive comorbidities
Description
semi-structured clinical interview for DSM (SCID)
Time Frame
Inclusion
Title
Assessment of addictive comorbidities
Description
semi-structured clinical interview for DSM (SCID)
Time Frame
3 years
Title
Assessment of tobacco, alcohol and drug use
Description
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Time Frame
Every 6 months from inclusion
Title
Evaluation of the clinical impact of the intervention between groups
Description
Clinical Global Impression questionnaire (CGI)
Time Frame
Every 6 months from inclusion
Title
Psychotic and general symptoms
Description
Positive and Negative Symptom Scale (PANSS)
Time Frame
Every 6 months from inclusion
Title
Depressive symptoms
Description
Calgary Depression Scale for Schizophrenia (CDSS)
Time Frame
Every 6 months from inclusion
Title
Self- and hetero-aggressive behaviors
Description
according to Health of the Nation Outcome Scales (HoNOS) items 1 and 2
Time Frame
Every 6 months from inclusion
Title
Reported adverse events
Description
death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS
Time Frame
Inclusion
Title
Reported adverse events
Description
death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS
Time Frame
6 months
Title
Reported adverse events
Description
death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS
Time Frame
1 year
Title
Reported adverse events
Description
death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS
Time Frame
18 months
Title
Reported adverse events
Description
death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS
Time Frame
2 years
Title
Reported adverse events
Description
death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS
Time Frame
2.5 years
Title
Reported adverse events
Description
death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS
Time Frame
3 years
Title
Current suicidal ideations
Description
Calgary Depression Scale for Schizophrenia (CDSS)
Time Frame
Inclusion
Title
Current suicidal ideations
Description
Calgary Depression Scale for Schizophrenia (CDSS)
Time Frame
6 months
Title
Current suicidal ideations
Description
Calgary Depression Scale for Schizophrenia (CDSS)
Time Frame
1 year
Title
Current suicidal ideations
Description
Calgary Depression Scale for Schizophrenia (CDSS)
Time Frame
18 months
Title
Current suicidal ideations
Description
Calgary Depression Scale for Schizophrenia (CDSS)
Time Frame
2 years
Title
Current suicidal ideations
Description
Calgary Depression Scale for Schizophrenia (CDSS)
Time Frame
2.5 years
Title
Current suicidal ideations
Description
Calgary Depression Scale for Schizophrenia (CDSS)
Time Frame
3 years
Title
Assess the impact of the intervention on socio-professional functioning and quality of life
Description
Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation
Time Frame
Inclusion
Title
Assess the impact of the intervention on socio-professional functioning and quality of life
Description
Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation
Time Frame
6 months
Title
Assess the impact of the intervention on socio-professional functioning and quality of life
Description
Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation
Time Frame
1 year
Title
Assess the impact of the intervention on socio-professional functioning and quality of life
Description
Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation
Time Frame
18 months
Title
Assess the impact of the intervention on socio-professional functioning and quality of life
Description
Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation
Time Frame
2 years
Title
Assess the impact of the intervention on socio-professional functioning and quality of life
Description
Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation
Time Frame
2.5 years
Title
Assess the impact of the intervention on socio-professional functioning and quality of life
Description
Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation
Time Frame
3 years
Title
Social and occupational functioning
Description
Social and Occupational Functioning Assessment Scale (SOFAS)
Time Frame
Inclusion
Title
Social and occupational functioning
Description
Social and Occupational Functioning Assessment Scale (SOFAS)
Time Frame
6 months
Title
Social and occupational functioning
Description
Social and Occupational Functioning Assessment Scale (SOFAS)
Time Frame
1 year
Title
Social and occupational functioning
Description
Social and Occupational Functioning Assessment Scale (SOFAS)
Time Frame
18 months
Title
Social and occupational functioning
Description
Social and Occupational Functioning Assessment Scale (SOFAS)
Time Frame
2 years
Title
Social and occupational functioning
Description
Social and Occupational Functioning Assessment Scale (SOFAS)
Time Frame
2.5 years
Title
Social and occupational functioning
Description
Social and Occupational Functioning Assessment Scale (SOFAS)
Time Frame
3 years
Title
Social functioning
Description
Health of the Nation Outcome Scales
Time Frame
Inclusion
Title
Social functioning
Description
Health of the Nation Outcome Scales
Time Frame
6 months
Title
Social functioning
Description
Health of the Nation Outcome Scales
Time Frame
1 year
Title
Social functioning
Description
Health of the Nation Outcome Scales
Time Frame
18 months
Title
Social functioning
Description
Health of the Nation Outcome Scales
Time Frame
2 years
Title
Social functioning
Description
Health of the Nation Outcome Scales
Time Frame
2.5 years
Title
Social functioning
Description
Health of the Nation Outcome Scales
Time Frame
3 years
Title
Psychosocial functioning
Description
Quality of Life Scale (QLS) - semi-structured interview
Time Frame
Inclusion
Title
Psychosocial functioning
Description
Quality of Life Scale (QLS) - semi-structured interview
Time Frame
6 months
Title
Psychosocial functioning
Description
Quality of Life Scale (QLS) - semi-structured interview
Time Frame
1 year
Title
Psychosocial functioning
Description
Quality of Life Scale (QLS) - semi-structured interview
Time Frame
18 months
Title
Psychosocial functioning
Description
Quality of Life Scale (QLS) - semi-structured interview
Time Frame
2 years
Title
Psychosocial functioning
Description
Quality of Life Scale (QLS) - semi-structured interview
Time Frame
2.5 years
Title
Psychosocial functioning
Description
Quality of Life Scale (QLS) - semi-structured interview
Time Frame
3 years
Title
Functioning
Description
Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire
Time Frame
Inclusion
Title
Functioning
Description
Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire
Time Frame
6 months
Title
Functioning
Description
Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire
Time Frame
1 year
Title
Functioning
Description
Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire
Time Frame
18 months
Title
Functioning
Description
Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire
Time Frame
2 years
Title
Functioning
Description
Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire
Time Frame
2.5 years
Title
Functioning
Description
Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire
Time Frame
3 years
Title
Quality of life of users (patient and family)
Description
World Health Organization Quality of Life brief (WHOQOL-brief)
Time Frame
1 year
Title
Quality of life of users (patient and family)
Description
World Health Organization Quality of Life brief (WHOQOL-brief)
Time Frame
2 years
Title
Quality of life of users (patient and family)
Description
World Health Organization Quality of Life brief (WHOQOL-brief)
Time Frame
3 years
Title
Health-related quality of life
Description
EuroQol-5D 3 level version (EQ-5D-35L)
Time Frame
1 year
Title
Health-related quality of life
Description
EuroQol-5D 3 level version (EQ-5D-35L)
Time Frame
2 years
Title
Health-related quality of life
Description
EuroQol-5D 3 level version (EQ-5D-35L)
Time Frame
3 years
Title
Quality of life of relatives
Description
caregiver schizophrenia quality of life questionnaire (S-CGQoL)
Time Frame
1 year
Title
Quality of life of relatives
Description
caregiver schizophrenia quality of life questionnaire (S-CGQoL)
Time Frame
2 years
Title
Quality of life of relatives
Description
caregiver schizophrenia quality of life questionnaire (S-CGQoL)
Time Frame
3 years
Title
Cost-outcome type ratio
Description
the ratio of the difference in costs between the two strategies divided by the difference in QALYs. This ratio measures the cost per life-year gained in full health, i.e. a cost per QALY. This indicator is obtained by weighting the time spent in each health state h by the utility of that health state measured by the EQ-5D
Time Frame
3 years
Title
Cost of care
Description
assessed from a community perspective (health care system, out-of-pocket expenses, caregivers)
Time Frame
3 years
Title
Budget impact analysis between strategies
Description
National estimates of avoided costs, care consumption and the cost of implementing the system in the two management strategies
Time Frame
3 years
Title
Psychiatric assessment
Description
Structured Clinical Interview for DSM
Time Frame
Inclusion
Title
Psychiatric assessment
Description
Structured Clinical Interview for DSM
Time Frame
3 years
Title
Patient age
Time Frame
Inclusion
Title
Patient sex
Time Frame
Inclusion
Title
Current patient professional/training situation
Description
working or studying
Time Frame
Over the study until 3 years
Title
Financial situation
Time Frame
Over the study until 3 years
Title
Care pathways taken by patient
Description
specialist care sought
Time Frame
Over the study until 3 years
Title
Duration of non-treated psychosis
Description
Interval between start of psychotic symptoms and start of sufficient antipsychotic treatment
Time Frame
Inclusion
Title
Personal and family psychiatric history
Time Frame
Inclusion
Title
Social and academic function
Description
Premorbid Adjustment Scale
Time Frame
Inclusion
Title
Medical treatment received
Time Frame
Until 3 years
Title
Cerebral imagery
Description
Normal/abnormal
Time Frame
Inclusion
Title
Cerebral imagery
Description
Normal/abnormal
Time Frame
1 year
Title
Cerebral imagery
Description
Normal/abnormal
Time Frame
2 years
Title
IQ profile
Description
Homogenous/heterogenous
Time Frame
Inclusion
Title
IQ profile
Description
Homogenous/heterogenous
Time Frame
1 year
Title
IQ profile
Description
Homogenous/heterogenous
Time Frame
2 years
Title
IQ
Description
value
Time Frame
Inclusion
Title
IQ
Description
value
Time Frame
1 year
Title
IQ
Description
value
Time Frame
2 years
Title
BMI
Description
kg/m2
Time Frame
Inclusion
Title
BMI
Description
kg/m2
Time Frame
1 year
Title
BMI
Description
kg/m2
Time Frame
2 years
Title
Fasting glycemia
Description
mmol/l
Time Frame
Inclusion
Title
Fasting glycemia
Description
mmol/l
Time Frame
1 year
Title
Fasting glycemia
Description
mmol/l
Time Frame
2 years
Title
Lipid assessment
Description
Normal/abnormal
Time Frame
Inclusion
Title
Lipid assessment
Description
Normal/abnormal
Time Frame
1 year
Title
Lipid assessment
Description
Normal/abnormal
Time Frame
2 years
Title
Whole blood count
Description
Normal/abnormal
Time Frame
Inclusion
Title
Whole blood count
Description
Normal/abnormal
Time Frame
1 year
Title
Whole blood count
Description
Normal/abnormal
Time Frame
2 years
Title
Electrolytes
Description
Normal/abnormal
Time Frame
Inclusion
Title
Electrolytes
Description
Normal/abnormal
Time Frame
1 year
Title
Electrolytes
Description
Normal/abnormal
Time Frame
2 years
Title
Neurological exam
Description
Normal/abnormal
Time Frame
Inclusion
Title
Neurological exam
Description
Normal/abnormal
Time Frame
1 year
Title
Neurological exam
Description
Normal/abnormal
Time Frame
2 years
Title
Cardiovascular exam
Description
Normal/abnormal
Time Frame
Inclusion
Title
Cardiovascular exam
Description
Normal/abnormal
Time Frame
1 year
Title
Cardiovascular exam
Description
Normal/abnormal
Time Frame
2 years
Title
Morphological exam
Description
Normal/abnormal
Time Frame
Inclusion
Title
Morphological exam
Description
Normal/abnormal
Time Frame
1 year
Title
Morphological exam
Description
Normal/abnormal
Time Frame
2 years
Title
Hepatic exam
Description
Normal/abnormal
Time Frame
Inclusion
Title
Hepatic exam
Description
Normal/abnormal
Time Frame
1 year
Title
Hepatic exam
Description
Normal/abnormal
Time Frame
2 years
Title
Presence of neurometabolic disease
Description
Yes/no
Time Frame
Inclusion
Title
Presence of neurometabolic disease
Description
Yes/no
Time Frame
1 year
Title
Presence of neurometabolic disease
Description
Yes/no
Time Frame
2 years
Title
Electrocardiogram
Description
Normal/abnormal
Time Frame
Inclusion
Title
Electrocardiogram
Description
Normal/abnormal
Time Frame
1 year
Title
Electrocardiogram
Description
Normal/abnormal
Time Frame
2 years
Title
C-reactive protein
Description
mg/l
Time Frame
Inclusion
Title
C-reactive protein
Description
mg/l
Time Frame
1 year
Title
C-reactive protein
Description
mg/l
Time Frame
2 years
Title
thyroid-stimulating hormone
Description
mUI/l
Time Frame
Inclusion
Title
thyroid-stimulating hormone
Description
mUI/l
Time Frame
1 year
Title
thyroid-stimulating hormone
Description
mUI/l
Time Frame
2 years
Title
Cortisol
Description
nmol/l
Time Frame
Inclusion
Title
Cortisol
Description
nmol/l
Time Frame
1 year
Title
Cortisol
Description
nmol/l
Time Frame
2 years
Title
Adverse events
Description
Any of the following (yes/no): Neurological symptoms, overweight, metabolic syndrome, sexual dysfunction, fatigue, salivation dysfunction, other
Time Frame
Inclusion
Title
Adverse events
Description
Any of the following (yes/no): Neurological symptoms, overweight, metabolic syndrome, sexual dysfunction, fatigue, salivation dysfunction, other
Time Frame
1 year
Title
Adverse events
Description
Any of the following (yes/no): Neurological symptoms, overweight, metabolic syndrome, sexual dysfunction, fatigue, salivation dysfunction, other
Time Frame
2 years
Title
Non-medical treatment received
Description
Psychosocial/psychotherapy interventions
Time Frame
Until 3 years
Title
In the experimental group: case management according to good practice guidelines
Description
EPPIC Model Integrity Tool (80 items with subscores)
Time Frame
End of follow-up (3 years)
Title
In the experimental group: Conformity of case management
Description
Index of Fidelity to Assertive Community Treatment (16 criteria of conformity for three dimensions)
Time Frame
End of study (5 years)
Title
In the experimental group: conformity to TIDieR checklist in each patient
Description
TIDieR checklist-patient
Time Frame
Month 3
Title
In the experimental group: conformity to TIDieR checklist in each patient
Description
TIDieR checklist-patient
Time Frame
Month 6
Title
In the experimental group: conformity to TIDieR checklist in each patient
Description
TIDieR checklist-patient
Time Frame
1 year
Title
In the experimental group: conformity to TIDieR checklist in each patient
Description
TIDieR checklist-patient
Time Frame
18 Months
Title
In the experimental group: conformity to TIDieR checklist in each patient
Description
TIDieR checklist-patient
Time Frame
2 years
Title
In the experimental group: conformity to TIDieR checklist in each patient
Description
TIDieR checklist-patient
Time Frame
30 Months
Title
In the experimental group: conformity to TIDieR checklist in each patient
Description
TIDieR checklist-patient
Time Frame
3 years
Title
In the experimental group: conformity to TIDieR checklist in each center
Description
Customized TIDieR checklist-center
Time Frame
Annually until end of study (5 years)
Title
Satisfaction of patients and their families
Description
Client Satisfaction Questionnaire (CSQ)-8
Time Frame
1 year
Title
Satisfaction of patients and their families
Description
Client Satisfaction Questionnaire (CSQ)-8
Time Frame
2 years
Title
Satisfaction of patients and their families
Description
Client Satisfaction Questionnaire (CSQ)-8
Time Frame
3 years
Title
Satisfaction of participants receiving help from a health coordinator
Description
7-item custom questionnaire with free answer section
Time Frame
End of follow-up (3 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient or their close relative must have given their free and informed consent and signed the consent form The patient must be a member or beneficiary of a health insurance plan The patient is available for a 3-year follow-up. Patient is managed in a psychiatric service (consultation or hospitalization) for a first episode psychosis defined by: Presence of positive psychotic symptoms (delusion(s) and/or hallucination(s) and/or conceptual disorganization) evolving for at least one week, either daily or at least 3 times per week for at least one hour per occasion ; Never having taken a neuroleptic treatment with antipsychotic aim (except for an antipsychotic treatment started for the current episode for example by the general practitioner before being referred to psychiatry); A disorder meeting the DSM 5 criteria from the following list: delusional disorder, brief psychotic disorder greater than 7 days, schizophreniform disorder, schizophrenia, schizoaffective disorder, substance-induced psychotic disorder greater than 7 days, other specific or nonspecific schizophrenic spectrum disorder or other psychotic disorder, bipolar I or II disorder with congruent and non-mood congruent psychotic features, bipolar disorder with congruent and non-mood congruent psychotic features induced by a substance, major depressive disorder with congruent and non-mood congruent psychotic features. Inclusion should be within the first 3 months of care for first episode psychosis in the psychiatric service. At the time of inclusion, the psychotic symptomatology observed during the first episode psychosis may still be present or in remission. Exclusion Criteria: The subject is participating in another category I interventional study, or is in a period of exclusion determined by a previous study The subject, or one of the parents for minor patients, refuses to sign the consent It is impossible to give the subject informed information The patient is under safeguard of justice or state guardianship The patients has an IQ less than or equal to 55 The patient has a first psychotic episode linked to a psychotic problem triggered by a medication of other medical condition The patient is pregnant or breastfeeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aurélie Schandrin
Phone
04.66.68.34.26
Email
aurelie.schandrin@chu-nimes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aurélie Schandrin
Organizational Affiliation
CHU Nimes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de TOULOUSE
City
Toulouse
State/Province
Choisir Une Région
ZIP/Postal Code
31
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ETIENNE VERY
Phone
05.61.77.22.33
Email
very-e@chu-toulouse.fr
Facility Name
CH Saint Marie Clermont-Ferrand
City
Clermont-Ferrand
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sébastien ALMON
Email
sebastien.almon@hotmail.fr
Facility Name
CHU de Montpellier
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Delphine CAPDEVIELLE
Phone
04.67.33.97.02
Email
d-capdevielle@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Delphine CAPDEVIELLE
First Name & Middle Initial & Last Name & Degree
Diane PURPER-OUAKIL
Facility Name
CHU Nice
City
Nice
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno GIORDANA
Phone
04.92.03.76.09
Email
giordana.b@chu-nice.fr
Facility Name
CHU de Nîmes
City
Nîmes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anissa Megzari
Phone
04.66.68.42.36
Email
drc@chu-nimes.fr
First Name & Middle Initial & Last Name & Degree
Aurélie SCHANDRIN
First Name & Middle Initial & Last Name & Degree
Mocrane Abbar
First Name & Middle Initial & Last Name & Degree
Jorge LOPEZ -CASTROMAN
Facility Name
Centre Hospitalier Léon-Jean Grégory
City
Thuir
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurore LARUE
Phone
04.68.84.66.20
Email
aurore.larue@ch-thuir.fr

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the Impact of Case Manager Intervention on the 3-year Psychotic Episode Recurrence Rate in Patients Aged 16 to 30 Years With a First Psychotic Episode.

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