Investigator Initiated Study - Asenapine Early Psychosis

Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec

Status and phase: Unknown; Phase 4

Conditions: Schizophrenia and Disorders With Psychotic Features; Disorders

Treatments: Drug: Asenapine

Study type: Interventional

Funder types: Other

Identifiers

NCT01968161

IIS - Switch Asenapine

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Asenapine

Other group

Description:

Open label switch to asenapine: asenapine will be introduced at the target dose (5 mg bid)

Treatment:

Drug: Asenapine