Investigator Initiated Study - Asenapine Early Psychosis

Schizophrenia and Disorders With Psychotic Features Clinical Trial

Official title:

An Open-label Switch Study to Asenapine in the Early Stage of Psychosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01968161
• Other study ID #: IIS - Switch Asenapine
• Status: Not yet recruiting
• Phase: Phase 4
• First received: October 16, 2013
• Last updated: January 8, 2014
• Start date: October 2013
• Est. completion date: March 2014

Study information

• Verified date: January 2014
• Source: Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: March 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Disorders
• Schizophrenia and Disorders With Psychotic Features

Intervention

Drug:
• Asenapine

Locations

Country	Name	City	State
Canada	Clinique Notre-Dame des Victoires	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of switching to asenapine		3 months	Yes
Secondary	Predictors of successful switch to asenapine		3 months	No