Individualized care with antipsychotics in patients suffering from schizophrenia spectrum disorders-How to conciliate plasma concentrations, clinical response and genetic factors ?

CLouvain0 sites100 target enrollmentOctober 12, 2021

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Schizophrenia, schizoaffective disorders,psychosis not otherwise specified, and dellusional disorders
Sponsor: CLouvain
Enrollment: 100
Status: Active, not recruiting
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

October 12, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

CLouvain

•Inclusion criteria are : (1\) diagnosis of schizophrenia\-spectrum disorders7 (DSM\-V 295\.xx,
•298\.9 and 297\.1 ; or ICD\-10 F20\.xx, F25\.xx, F29 and F22; or ICD\-11 6A20, 6A21, 6A2Z and
•6A24\), (2\) hospitalized in a psychiatric unit of each center for an acute episode of psychosis, (3\) aged between 18 and 65 years old at admission; and (4\) taking a monotherapy8 of
•aripiprazole, olanzapine or risperidone at admission or any time during their hospital stay for
•their psychotic symptoms until steady state of their antipsychotic is reached.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 100
•F.1\.3 Elderly (\>\=65 years) no

•Exclusion criteria are: (1\) comorbid disorder of intellectual development (i.e. intellectual
•disability also commonly called mental retardation, DSM\-V criteria 317\.xx and 318\.xx), (2\)
•comorbid serious uncontrolled illness or dementia9; (3\) comorbid substance use disorder (DSMV
•305\.20, 304\.30, 305\.90, 304\.60, 305\.30, 304\.50, 305\.50, 304\.00, 305\.40, 304\.10, 305\.70,
•305\.60, 304\.40, 304\.20\) in case of consumption during the hospital stay10 (4\) comorbid alcohol
•use disorder (DSM\-V 305\.00 and 303\.90\); (5\) women with a current pregnancy11 ; (6\)
•hospitalization for a social purpose (e.g. nursing home time out) or planned hospitalization
•without exacerbation ; (7\) patients not speaking French, English or Dutch to a standard
•necessary to receive the assessment scales; (8\) patients with an hepatic fibrosis Child Pugh C
•and severe renal failure (i.e. Clcr \<30 mL/min) identified through chart review.