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)

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.

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

Study Overview

• Status: Recruiting
• Conditions: Psychotic Episode
• Intervention / Treatment: Other: Case management

• Study Type: Interventional
• Enrollment (Estimated): 256
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aurélie Schandrin; Phone Number: 04.66.68.34.26; Email: aurelie.schandrin@chu-nimes.fr

Study Locations

• France
  • Clermont-Ferrand, France
    • Not yet recruiting
    • CH Saint Marie Clermont-Ferrand
    • Contact: Sébastien ALMON; Email: sebastien.almon@hotmail.fr
  • Montpellier, France
    • Recruiting
    • CHU de Montpellier
    • Contact: Delphine CAPDEVIELLE; Phone Number: 04.67.33.97.02; Email: d-capdevielle@chu-montpellier.fr
    • Principal Investigator: Delphine CAPDEVIELLE
    • Sub-Investigator: Diane PURPER-OUAKIL
  • Nice, France
    • Not yet recruiting
    • CHU Nice
    • Contact: Bruno GIORDANA; Phone Number: 04.92.03.76.09; Email: giordana.b@chu-nice.fr
  • Nîmes, France
    • Recruiting
    • CHU de Nimes
    • Principal Investigator: Aurélie SCHANDRIN
    • Sub-Investigator: Mocrane Abbar
    • Sub-Investigator: Jorge LOPEZ -CASTROMAN
    • Contact: Anissa Megzari; Phone Number: 04.66.68.42.36; Email: drc@chu-nimes.fr
  • Thuir, France
    • Recruiting
    • Centre Hospitalier Léon-Jean Grégory
    • Contact: Aurore LARUE; Phone Number: 04.68.84.66.20; Email: aurore.larue@ch-thuir.fr
  • Choisir Une Région
    • Toulouse, Choisir Une Région, France, 31
      • Not yet recruiting
      • CHU de Toulouse
      • Contact: ETIENNE VERY; Phone Number: 05.61.77.22.33; Email: very-e@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Case manager group	Other: Case management; Regular and personalized follow-up by a case manager using a "case management" approach, updated every 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the impact of the intervention on the number of recurrences of psychiatric hospitalization per patient	number	1 year
Evaluate the impact of the intervention on the number of recurrences of psychiatric hospitalization per patient	number	2 years
Evaluate the impact of the intervention on the number of recurrences of psychiatric hospitalization per patient	number	3 years
Evaluate the impact of the intervention on the number of psychiatric hospitalizations per patient	number	1 year
Evaluate the impact of the intervention on the number of psychiatric hospitalizations per patient	number	2 years
Evaluate the impact of the intervention on the number of psychiatric hospitalizations per patient	number	3 years
Evaluate the impact of the intervention on the duration of psychiatric hospitalization per patient	days/weeks/months	1 year
Evaluate the impact of the intervention on the duration of psychiatric hospitalization per patient	days/weeks/months	2 years
Evaluate the impact of the intervention on the duration of psychiatric hospitalization per patient	days/weeks/months	3 years
Percentage per patient of medical and caregiving appointments honored between groups		Inclusion
Percentage per patient of medical and caregiving appointments honored between groups		6 months
Percentage per patient of medical and caregiving appointments honored between groups		1 year
Percentage per patient of medical and caregiving appointments honored between groups		18 months
Percentage per patient of medical and caregiving appointments honored between groups		2 years
Percentage per patient of medical and caregiving appointments honored between groups		2.5 years
Percentage per patient of medical and caregiving appointments honored between groups		3 years
Type of hospital admission (voluntary versus involuntary) between groups	% voluntary versus involuntary	Inclusion
Type of hospital admission (voluntary versus involuntary) between groups	% voluntary versus involuntary	6 months
Type of hospital admission (voluntary versus involuntary) between groups	% voluntary versus involuntary	1 year
Type of hospital admission (voluntary versus involuntary) between groups	% voluntary versus involuntary	18 months
Type of hospital admission (voluntary versus involuntary) between groups	% voluntary versus involuntary	2 years
Type of hospital admission (voluntary versus involuntary) between groups	% voluntary versus involuntary	2.5 years
Type of hospital admission (voluntary versus involuntary) between groups	% voluntary versus involuntary	3 years
Unscheduled discharge from care between groups	Defined by a break in follow-up organized by the referring care team for more than 30 days	Inclusion
Unscheduled discharge from care between groups	Defined by a break in follow-up organized by the referring care team for more than 30 days	6 months
Unscheduled discharge from care between groups	Defined by a break in follow-up organized by the referring care team for more than 30 days	1 year
Unscheduled discharge from care between groups	Defined by a break in follow-up organized by the referring care team for more than 30 days	18 months
Unscheduled discharge from care between groups	Defined by a break in follow-up organized by the referring care team for more than 30 days	2 years
Unscheduled discharge from care between groups	Defined by a break in follow-up organized by the referring care team for more than 30 days	2.5 years
Unscheduled discharge from care between groups	Defined by a break in follow-up organized by the referring care team for more than 30 days	3 years
Treatment compliance between groups	item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)	Inclusion
Treatment compliance between groups	item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)	6 months
Treatment compliance between groups	item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)	1 year
Treatment compliance between groups	item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)	18 months
Treatment compliance between groups	item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)	2 years
Treatment compliance between groups	item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)	2.5 years
Treatment compliance between groups	item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)	3 years
Adherence to treatment	Medication Adherence Rating Scale (MARS, self-administered questionnaire)	1 year
Adherence to treatment	Medication Adherence Rating Scale (MARS, self-administered questionnaire)	2 years
Adherence to treatment	Medication Adherence Rating Scale (MARS, self-administered questionnaire)	3 years
Therapeutic alliance	Working Alliance Inventory-Short Revised (WAI-SR, self-administered questionnaire)	1 year
Therapeutic alliance	Working Alliance Inventory-Short Revised (WAI-SR, self-administered questionnaire)	2 years
Therapeutic alliance	Working Alliance Inventory-Short Revised (WAI-SR, self-administered questionnaire)	3 years
Patient awareness of disorders and of the need for treatment	Birchwood Insight Scale (BIS, self-administered questionnaire)	1 year
Patient awareness of disorders and of the need for treatment	Birchwood Insight Scale (BIS, self-administered questionnaire)	2 years
Patient awareness of disorders and of the need for treatment	Birchwood Insight Scale (BIS, self-administered questionnaire)	3 years
Assessment of addictive comorbidities	semi-structured clinical interview for DSM (SCID)	Inclusion
Assessment of addictive comorbidities	semi-structured clinical interview for DSM (SCID)	3 years
Assessment of tobacco, alcohol and drug use	Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)	Every 6 months from inclusion
Evaluation of the clinical impact of the intervention between groups	Clinical Global Impression questionnaire (CGI)	Every 6 months from inclusion
Psychotic and general symptoms	Positive and Negative Symptom Scale (PANSS)	Every 6 months from inclusion
Depressive symptoms	Calgary Depression Scale for Schizophrenia (CDSS)	Every 6 months from inclusion
Self- and hetero-aggressive behaviors	according to Health of the Nation Outcome Scales (HoNOS) items 1 and 2	Every 6 months from inclusion
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	Inclusion
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	6 months
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	1 year
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	18 months
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	2 years
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	2.5 years
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	3 years
Current suicidal ideations	Calgary Depression Scale for Schizophrenia (CDSS)	Inclusion
Current suicidal ideations	Calgary Depression Scale for Schizophrenia (CDSS)	6 months
Current suicidal ideations	Calgary Depression Scale for Schizophrenia (CDSS)	1 year
Current suicidal ideations	Calgary Depression Scale for Schizophrenia (CDSS)	18 months
Current suicidal ideations	Calgary Depression Scale for Schizophrenia (CDSS)	2 years
Current suicidal ideations	Calgary Depression Scale for Schizophrenia (CDSS)	2.5 years
Current suicidal ideations	Calgary Depression Scale for Schizophrenia (CDSS)	3 years
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	Inclusion
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	6 months
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	1 year
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	18 months
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	2 years
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	2.5 years
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	3 years
Social and occupational functioning	Social and Occupational Functioning Assessment Scale (SOFAS)	Inclusion
Social and occupational functioning	Social and Occupational Functioning Assessment Scale (SOFAS)	6 months
Social and occupational functioning	Social and Occupational Functioning Assessment Scale (SOFAS)	1 year
Social and occupational functioning	Social and Occupational Functioning Assessment Scale (SOFAS)	18 months
Social and occupational functioning	Social and Occupational Functioning Assessment Scale (SOFAS)	2 years
Social and occupational functioning	Social and Occupational Functioning Assessment Scale (SOFAS)	2.5 years
Social and occupational functioning	Social and Occupational Functioning Assessment Scale (SOFAS)	3 years
Social functioning	Health of the Nation Outcome Scales	Inclusion
Social functioning	Health of the Nation Outcome Scales	6 months
Social functioning	Health of the Nation Outcome Scales	1 year
Social functioning	Health of the Nation Outcome Scales	18 months
Social functioning	Health of the Nation Outcome Scales	2 years
Social functioning	Health of the Nation Outcome Scales	2.5 years
Social functioning	Health of the Nation Outcome Scales	3 years
Psychosocial functioning	Quality of Life Scale (QLS) - semi-structured interview	Inclusion
Psychosocial functioning	Quality of Life Scale (QLS) - semi-structured interview	6 months
Psychosocial functioning	Quality of Life Scale (QLS) - semi-structured interview	1 year
Psychosocial functioning	Quality of Life Scale (QLS) - semi-structured interview	18 months
Psychosocial functioning	Quality of Life Scale (QLS) - semi-structured interview	2 years
Psychosocial functioning	Quality of Life Scale (QLS) - semi-structured interview	2.5 years
Psychosocial functioning	Quality of Life Scale (QLS) - semi-structured interview	3 years
Functioning	Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire	Inclusion
Functioning	Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire	6 months
Functioning	Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire	1 year
Functioning	Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire	18 months
Functioning	Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire	2 years
Functioning	Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire	2.5 years
Functioning	Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire	3 years
Quality of life of users (patient and family)	World Health Organization Quality of Life brief (WHOQOL-brief)	1 year
Quality of life of users (patient and family)	World Health Organization Quality of Life brief (WHOQOL-brief)	2 years
Quality of life of users (patient and family)	World Health Organization Quality of Life brief (WHOQOL-brief)	3 years
Health-related quality of life	EuroQol-5D 3 level version (EQ-5D-35L)	1 year
Health-related quality of life	EuroQol-5D 3 level version (EQ-5D-35L)	2 years
Health-related quality of life	EuroQol-5D 3 level version (EQ-5D-35L)	3 years
Quality of life of relatives	caregiver schizophrenia quality of life questionnaire (S-CGQoL)	1 year
Quality of life of relatives	caregiver schizophrenia quality of life questionnaire (S-CGQoL)	2 years
Quality of life of relatives	caregiver schizophrenia quality of life questionnaire (S-CGQoL)	3 years
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	3 years
Cost of care	assessed from a community perspective (health care system, out-of-pocket expenses, caregivers)	3 years
Budget impact analysis between strategies	National estimates of avoided costs, care consumption and the cost of implementing the system in the two management strategies	3 years
Psychiatric assessment	Structured Clinical Interview for DSM	Inclusion
Psychiatric assessment	Structured Clinical Interview for DSM	3 years
Patient age		Inclusion
Patient sex		Inclusion
Current patient professional/training situation	working or studying	Over the study until 3 years
Financial situation		Over the study until 3 years
Care pathways taken by patient	specialist care sought	Over the study until 3 years
Duration of non-treated psychosis	Interval between start of psychotic symptoms and start of sufficient antipsychotic treatment	Inclusion
Personal and family psychiatric history		Inclusion
Social and academic function	Premorbid Adjustment Scale	Inclusion
Medical treatment received		Until 3 years
Cerebral imagery	Normal/abnormal	Inclusion
Cerebral imagery	Normal/abnormal	1 year
Cerebral imagery	Normal/abnormal	2 years
IQ profile	Homogenous/heterogenous	Inclusion
IQ profile	Homogenous/heterogenous	1 year
IQ profile	Homogenous/heterogenous	2 years
IQ	value	Inclusion
IQ	value	1 year
IQ	value	2 years
BMI	kg/m2	Inclusion
BMI	kg/m2	1 year
BMI	kg/m2	2 years
Fasting glycemia	mmol/l	Inclusion
Fasting glycemia	mmol/l	1 year
Fasting glycemia	mmol/l	2 years
Lipid assessment	Normal/abnormal	Inclusion
Lipid assessment	Normal/abnormal	1 year
Lipid assessment	Normal/abnormal	2 years
Whole blood count	Normal/abnormal	Inclusion
Whole blood count	Normal/abnormal	1 year
Whole blood count	Normal/abnormal	2 years
Electrolytes	Normal/abnormal	Inclusion
Electrolytes	Normal/abnormal	1 year
Electrolytes	Normal/abnormal	2 years
Neurological exam	Normal/abnormal	Inclusion
Neurological exam	Normal/abnormal	1 year
Neurological exam	Normal/abnormal	2 years
Cardiovascular exam	Normal/abnormal	Inclusion
Cardiovascular exam	Normal/abnormal	1 year
Cardiovascular exam	Normal/abnormal	2 years
Morphological exam	Normal/abnormal	Inclusion
Morphological exam	Normal/abnormal	1 year
Morphological exam	Normal/abnormal	2 years
Hepatic exam	Normal/abnormal	Inclusion
Hepatic exam	Normal/abnormal	1 year
Hepatic exam	Normal/abnormal	2 years
Presence of neurometabolic disease	Yes/no	Inclusion
Presence of neurometabolic disease	Yes/no	1 year
Presence of neurometabolic disease	Yes/no	2 years
Electrocardiogram	Normal/abnormal	Inclusion
Electrocardiogram	Normal/abnormal	1 year
Electrocardiogram	Normal/abnormal	2 years
C-reactive protein	mg/l	Inclusion
C-reactive protein	mg/l	1 year
C-reactive protein	mg/l	2 years
thyroid-stimulating hormone	mUI/l	Inclusion
thyroid-stimulating hormone	mUI/l	1 year
thyroid-stimulating hormone	mUI/l	2 years
Cortisol	nmol/l	Inclusion
Cortisol	nmol/l	1 year
Cortisol	nmol/l	2 years
Adverse events	Any of the following (yes/no): Neurological symptoms, overweight, metabolic syndrome, sexual dysfunction, fatigue, salivation dysfunction, other	Inclusion
Adverse events	Any of the following (yes/no): Neurological symptoms, overweight, metabolic syndrome, sexual dysfunction, fatigue, salivation dysfunction, other	1 year
Adverse events	Any of the following (yes/no): Neurological symptoms, overweight, metabolic syndrome, sexual dysfunction, fatigue, salivation dysfunction, other	2 years
Non-medical treatment received	Psychosocial/psychotherapy interventions	Until 3 years
In the experimental group: case management according to good practice guidelines	EPPIC Model Integrity Tool (80 items with subscores)	End of follow-up (3 years)
In the experimental group: Conformity of case management	Index of Fidelity to Assertive Community Treatment (16 criteria of conformity for three dimensions)	End of study (5 years)
In the experimental group: conformity to TIDieR checklist in each patient	TIDieR checklist-patient	Month 3
In the experimental group: conformity to TIDieR checklist in each patient	TIDieR checklist-patient	Month 6
In the experimental group: conformity to TIDieR checklist in each patient	TIDieR checklist-patient	1 year
In the experimental group: conformity to TIDieR checklist in each patient	TIDieR checklist-patient	18 Months
In the experimental group: conformity to TIDieR checklist in each patient	TIDieR checklist-patient	2 years
In the experimental group: conformity to TIDieR checklist in each patient	TIDieR checklist-patient	30 Months
In the experimental group: conformity to TIDieR checklist in each patient	TIDieR checklist-patient	3 years
In the experimental group: conformity to TIDieR checklist in each center	Customized TIDieR checklist-center	Annually until end of study (5 years)
Satisfaction of patients and their families	Client Satisfaction Questionnaire (CSQ)-8	1 year
Satisfaction of patients and their families	Client Satisfaction Questionnaire (CSQ)-8	2 years
Satisfaction of patients and their families	Client Satisfaction Questionnaire (CSQ)-8	3 years
Satisfaction of participants receiving help from a health coordinator	7-item custom questionnaire with free answer section	End of follow-up (3 years)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Aurélie Schandrin, Chu Nimes

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2021
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: October 5, 2021
• First Submitted That Met QC Criteria: November 8, 2021
• First Posted (Actual): November 11, 2021

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Recurrence; Mental Disorders
• Other Study ID Numbers: PREPS/2018/AS-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No