Investigator Initiated Study - Asenapine Early Psychosis

Phase 4

• Conditions: Schizophrenia and Disorders With Psychotic Features; Disorders
• Interventions: Drug: Asenapine

• Registration Number: NCT01968161
• Lead Sponsor: Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-16
• Study First Submitted QC: 2013-10-22
• Study First Posted: 2013-10-23
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-08
• Last Update Posted: 2014-01-09
• Primary Completion: 2014-02
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Impact of switching to asenapine	3 months

Secondary Outcome Measures

Name	Time	Method
Predictors of successful switch to asenapine	3 months

Trial Locations

Locations (1)

Clinique Notre-Dame des Victoires; 🇨🇦 Quebec, Canada