Clinical trial • Phase III • Psychiatry

ACETYLCYSTEINE for Ultra-high risk of psychosis | First-episode psychosis

Phase III trial of ACETYLCYSTEINE for Ultra-high risk of psychosis | First-episode psychosis.

Overview

Trial Therapeutic Area
Psychiatry
Trial Disease
Ultra-high risk of psychosis | First-episode psychosis
Trial Stage
Phase III
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
22-01-2025
First CTIS Authorization Date
30-01-2025

Trial design

Randomised, open-label, treatment as usual (tau) is the comparator. trial arms include: cpc a: adaptation of add-on medications (biological add-on neuroprotective medication / vitamin supplementation such as omacor (omega-3 acid ethyl esters), acetylcysteine (mucodrill), calcium folinate (folinoral), cyanocobalamin (vitamin b12)); cpc b: digital cognitive reinforcement; cpc a+b: combination of both. doses/schedules not specified in the trial documents.-controlled Phase III trial in France.

Randomised
Yes
Open Label
Yes
Comparator
Treatment as usual (TAU) is the comparator. Trial arms include: CPC A: adaptation of add-on medications (biological add-on neuroprotective medication / vitamin supplementation such as Omacor (omega-3 acid ethyl esters), acetylcysteine (MUCODRILL), calcium folinate (FOLINORAL), cyanocobalamin (Vitamin B12)); CPC B: digital cognitive reinforcement; CPC A+B: combination of both. Doses/schedules not specified in the trial documents.
Target Sample Size
500
Trial Duration For Participant
90

Eligibility

Recruits 500 paediatric patients.

Pregnancy Exclusion
Pregnant women, parturients, and lactating women
Vulnerable Population
Includes adolescents (15-17 years). Informed written consent is required; for minors consent must be signed by the holder of parental authority and the investigator. Subject information and ICF documents for minors, parents and adults are provided. Individuals deprived of liberty and those under legal protection are explicitly excluded.

Inclusion criteria

  • {"criterion_text":"-\tAdolescent and young adults, both sexes, aged 15 to 30 years,"}
  • {"criterion_text":"-\tPersons characterised according to the CAARMS criteria as UHR or FEP in the first two years after having received diagnosis and care, if any"}
  • {"criterion_text":"-\tInformed and written signed consent"}
  • {"criterion_text":"-\tParticipant with regular health insurance (AME is not considered as a regular health insurance)"}

Exclusion criteria

  • {"criterion_text":"Severe and unstabilised medical conditions"}
  • {"criterion_text":"Current daily use of substance of abuse other than nicotine and alcohol and higher than an average equivalent of 10 cannabis cigarettes AND/OR severe substance use disorder (DSMV criteria/dependence DSMIV criteria) other than nicotine during the last 12 months or for more than 5 years."}
  • {"criterion_text":"Pregnant women, parturients, and lactating women"}
  • {"criterion_text":"Individuals deprived of their liberty by a judicial or administrative decision, persons under psychiatric care under articles L3212-1 and 3213-1 (Public Health Code)"}
  • {"criterion_text":"Individuals of legal age who are the subject of a legal protection measure or unable to express their consent"}
  • {"criterion_text":"Insufficient level in reading and/or French language,"}
  • {"criterion_text":"Current participation in another intervention trial or in a full cognitive remediation programme"}
  • {"criterion_text":"Enforced hospitalization (ASPDT, ASPPI, ASPRE)"}
  • {"criterion_text":"Intellectual Deficiency (i.e. IQ<70), and / or sensorimotor deficits incompatible with a cognitive reinforcement"}
  • {"criterion_text":"Former treated episode of psychosis, chronic schizophrenia, schizoaffective, or Bipolar disorder (preceeding the 24 months established in the inclusion criteria)"}
  • {"criterion_text":"Current severe depression (in case of doubt, MADRS > 34 criterium)"}
  • {"criterion_text":"Receiving therapeutic levels of antipsychotics for more than 24 months"}
  • {"criterion_text":"Current medication with benzodiazepine >30 mg per day equivalent diazepam"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Global functioning will be assessed using the Personal and Social Performance Scale (PSP), determined reference period 3 to 4 months after the begning","definition_or_measurement_approach":"PSP assessed at 3-4 months after inclusion. The PSP provides a single overall score ranging from 1 to 100, subdivided into 10 equal intervals; higher scores indicate better personal and social functioning. (PSP derived from SOFAS)"}

Recruitment

Planned Sample Size
500
Recruitment Window Months
50
Consent Approach
Informed written consent required. For minors, consent must be signed by the holder of parental authority and the investigator. Separate subject information and informed consent forms exist for minors, parents, adults and participants who become adults during the trial.

Geography

Total Number Of Sites
14
Total Number Of Participants
500

France

Earliest CTIS Part Ii Submission Date
20-01-2025
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
465
Number Of Sites
14
Number Of Participants
500

Sites

Site Name
University Hospital Of Clermont-Ferrand
Department Name
Unité Pass'âge Pôle Psychiatrie enfant-adulte
Principal Investigator Name
Isabelle JALENQUES
Principal Investigator Email
ijalenques@chu-clermontferrand.fr
Contact Person Name
Isabelle JALENQUES
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
PSYCHIATRIE
Principal Investigator Name
CHRISTOPHE LEMEY
Principal Investigator Email
christophe.lemey@chu-brest.fr
Contact Person Name
CHRISTOPHE LEMEY
Contact Person Email
christophe.lemey@chu-brest.fr
Site Name
Groupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience
Department Name
PSYCHIATRIE
Principal Investigator Name
Gilles Martinez
Principal Investigator Email
gilles.martinez@ghu-paris.fr
Contact Person Name
Gilles Martinez
Contact Person Email
gilles.martinez@ghu-paris.fr
Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
PSYCHIATRIE
Principal Investigator Name
SONIA Dollfus
Principal Investigator Email
Dollfus-s@chu-caen.fr
Contact Person Name
SONIA Dollfus
Contact Person Email
Dollfus-s@chu-caen.fr
Site Name
Groupe Hospitalier Nord Essonne
Department Name
PSYCHIATRIE
Principal Investigator Name
JULIE BOURGIN
Principal Investigator Email
J.BOURGINDUCHESNAY@gh-nord-essonne.fr
Contact Person Name
JULIE BOURGIN
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
PSYCHIATRIE
Principal Investigator Name
CLEMENT DONDE COQUELET
Principal Investigator Email
CDondecoquelet@chu-grenoble.fr
Contact Person Name
CLEMENT DONDE COQUELET
Contact Person Email
CDondecoquelet@chu-grenoble.fr
Site Name
Centre Psychotherapique De Nancy
Department Name
UNité de recherche et d'Investigation Clinique (UNIC)
Principal Investigator Name
Vincent LAPRÉVOTE
Principal Investigator Email
Vincent.LAPREVOTE@cpn-laxou.com
Contact Person Name
Vincent LAPRÉVOTE
Site Name
Centre Hospitalier La Chartreuse
Department Name
PSYCHIATRIE
Principal Investigator Name
Juliette MARTIN
Principal Investigator Email
juliette.martin@chlcdijon.fr
Contact Person Name
Juliette MARTIN
Contact Person Email
juliette.martin@chlcdijon.fr
Site Name
Centre Hospotalier Guillaume Regnier
Department Name
PSYCHIATRIE
Principal Investigator Name
DRAPIER Dominique
Principal Investigator Email
d.drapier@ch-guillaumeregnier.fr
Contact Person Name
DRAPIER Dominique
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Le CIPP Centre d'Intervention Précoce pour Psychose
Principal Investigator Name
Diane PURPER OUAKIL
Principal Investigator Email
d-purper_ouakil@chu-montpellier.fr
Contact Person Name
Diane PURPER OUAKIL
Site Name
Groupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience
Department Name
PSYCHIATRIE
Principal Investigator Name
MARIE ORDILE KREBS
Principal Investigator Email
MO.KREBS@ghu-paris.fr
Contact Person Name
MARIE ORDILE KREBS
Contact Person Email
MO.KREBS@ghu-paris.fr
Site Name
Centre Hospitalier Henri Laborit
Department Name
PSYCHIATRIE
Principal Investigator Name
Nemat JAAFARI
Principal Investigator Email
nemat.jaafari@ch-poitiers.fr
Contact Person Name
Nemat JAAFARI
Contact Person Email
nemat.jaafari@ch-poitiers.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
PSYCHIATRIE
Principal Investigator Name
Grégoire BENVEGNU
Principal Investigator Email
benvegnu.g@chu-toulouse.fr
Contact Person Name
Grégoire BENVEGNU
Contact Person Email
benvegnu.g@chu-toulouse.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
PSYCHIATRIE
Principal Investigator Name
RENAUD JARDRI
Principal Investigator Email
drs.promotion@chru-lille.fr
Contact Person Name
RENAUD JARDRI
Contact Person Email
drs.promotion@chru-lille.fr

Sponsor

Primary sponsor

Full Name
Groupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
MUCODRILL 600 mg SANS SUCRE, comprimé effervescent édulcoré au sucralose
Active Substance
ACETYLCYSTEINE
Modality
Small molecule
Routes Of Administration
BUCCAL USE
Route
BUCCAL USE
Authorisation Status
Authorised
Maximum Dose
1800 mg
Investigational Product Name
FOLINORAL 25 mg, gélule
Active Substance
CALCIUM FOLINATE
Modality
Small molecule
Routes Of Administration
BUCCAL USE
Route
BUCCAL USE
Authorisation Status
Authorised
Maximum Dose
50 mg
Investigational Product Name
VITAMINE B12 GERDA 250 microgrammes, comprimé sécable
Active Substance
CYANOCOBALAMIN
Modality
Small molecule
Routes Of Administration
BUCCAL USE
Route
BUCCAL USE
Authorisation Status
Authorised
Maximum Dose
500 µg
Investigational Product Name
Omacor 1000 mg capsules molles
Active Substance
OMEGA-3-ACID ETHYL ESTERS 90
Modality
Small molecule
Routes Of Administration
BUCCAL USE
Route
BUCCAL USE
Authorisation Status
Authorised
Maximum Dose
3000 mg
Combination Treatment
Yes

Related trials

Other published trials that may interest you.