Schizophrenia, schizoaffective disorders, psychosis not otherwise specified, and dellusional disorders
Conditions
Interventions
Trade Name: Aripiprazole
Pharmaceutical Form: Tablet
INN or Proposed INN: Aripiprazole
CAS Number: 129722-12-9
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 5-30
Sponsors
UCLouvain
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Correlation between clinical response, plasma concentrations of each antipsychotic and genetic polymorphism of a panel of pharmacogenes, considering environmental factors (e.g. drug-drug interactions, smoking).;Timepoint(s) of evaluation of this end point: End of recruitement phase | — |
Primary
| Measure | Time frame |
|---|---|
| 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 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, considering environmental factors (e.g. drug-drug interactions, smoking).;Timepoint(s) of evaluation of this end point: End of recruitement phase | — |
Countries
Belgium
Contacts
Public ContactOlivia Dalleur
UCLouvain
Outcome results
None listed