Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-24 @ 7:34 PM
NCT ID:
NCT03542903
Eligibility Criteria:
Inclusion Criteria:
* Patients with URS: patients who continue to experience persistent positive psychotic symptoms: item score of 4 (moderate) on at least two of four positive symptoms on the BPRS (grandiosity, suspiciousness, hallucinations and unusual thoughts), current presence of at least moderately severe illness on the total BPRS-18 (45) and a score of 4 (moderate) on the CGI-S, despite a period of clozapine therapy of at least 6 weeks with a plasma concentration of 350 ng/ml and at least two unsuccessful previous treatment trials with conventional or atypical antipsychotic drugs from two distinct families at a dose 600 mg of chlorpromazine equivalents.
* Age: from 18 to 55
* Patients with stable treatments for at least 8 weeks (antipsychotics, mood stabilizers and antidepressants).
* Participants who gave their informed, written consents and agreement of their guardian for the patients under guardianship
* Patients deprived of liberty if they gave their informed, written consents
Exclusion Criteria:
* Current affective episode according to DSM-5 criteria;
* ECT within (the last) 6 months;
* Unstable epilepsy ; severe neurological or systemic disorder that could significantly affect cognition, behavior, or mental status (other than late dyskinesia or neuroleptic-induced parkinsonism);
* Severe substance use disorders (other than nicotine or caffeine) according to DSM-5 criteria.
* Concomitant use of antiepileptics and benzodiazepines apart from lamotrigine
* Women of childbearing age with no adequate contraception, pregnant or lactating women;
* Patients having contraindications to etomidate or any of its excipients;
* Patients having contraindications to neuromuscular blocking agents;
* Patients participating or having participated in an interventional clinical trial within 30 days prior to the inclusion visit;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03542903
Study Brief:
Protocol Section:
NCT03542903