Investigator Initiated Study - Asenapine Early Psychosis

• Status: Unknown status
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

We 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec
• Treatments: Asenapine

Criteria

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