Title
Investigator Initiated Study - Asenapine Early Psychosis
An Open-label Switch Study to Asenapine in the Early Stage of Psychosis
Phase
Phase 4Study Type
InterventionalStatus
Unknown statusIndication/Condition
Schizophrenia and Disorders With Psychotic Features ...Intervention/Treatment
asenapine ...Study Participants
12We propose a use of a unique facility, the databank at the CNDV, to examine the impact of switching subjects to asenapine in an open-label naturalistic setting. This offers the following advantages: i) providing data on a particularly important population, i.e., subjects who are at the inception of treatment for a psychotic disorder and who are likely to remain on a given drug on a long-term basis; ii) its inclusion in a rich clinical setting, with a clinical team dedicated to provide innovative interventions; iii) its naturalistic design, that will allow to obtain data that will be applicable to "real-life" clinical settings; indeed, subjects who will be switched to asenapine within the current project are those we would switch to this drug in our daily practice.
Open label switch to asenapine: asenapine will be introduced at the target dose (5 mg bid)
Inclusion Criteria: Meeting DSM-IV criteria for schizophrenia (SZ) or related SZ spectrum psychotic disorders having provided a consent to include data on our databank,and being able to provide informed consent willingness to participate to the assessments being over 18 years of age being in a clinical situation that warrants switch to asenapine Exclusion Criteria: suffering from a primary drug-induced psychosis being at significant risk for suicide or assault unstable medical condition persistence of psychotic symptoms despite adequate treatment to an extent that clozapine would be required being treated with antipsychotic for 5 years or more having contraindications(allergy to asenapine) being pregnant or lactating
