Individualized care with antipsychotics in patients suffering from schizophrenia spectrum disorders
- Conditions
- Schizophrenia, schizoaffective disorders,psychosis not otherwise specified, and dellusional disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2021-003588-85-BE
- Lead Sponsor
- CLouvain
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
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
F.1.3.1 Number of subjects for this age range
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The aim of this study is to detect the impact of several factors (i.e. genetic polymorphism, drug-drug interactions, smoking) on pharmacokinetics<br>of three atypical antipsychotics in a population suffering from schizophrenia spectrum disorders.;Secondary Objective: Clinical outcomes will also be measured in order to distinguish a real treatment-resistant schizophrenia from a suboptimal treatment.;Primary end point(s): Correlation between plasma concentrations of each antipsychotic and genetic polymorphism,<br>considering environmental factors (e.g. drug-drug interactions, smoking).;Timepoint(s) of evaluation of this end point: End of recruitement phase
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Correlation between clinical response, plasma concentrations of each antipsychotic and genetic<br>polymorphism of a panel of pharmacogenes, considering environmental factors (e.g. drug-drug<br>interactions, smoking).;Timepoint(s) of evaluation of this end point: End of recruitement phase