Investigator Initiated Study - Asenapine Early Psychosis

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

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.

Study Overview

• Status: Unknown
• Conditions: Disorders; Schizophrenia and Disorders With Psychotic Features
• Intervention / Treatment: Drug: Asenapine

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1K 4B2
    • Clinique Notre-Dame des Victoires

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Asenapine; Open label switch to asenapine: asenapine will be introduced at the target dose (5 mg bid)	Drug: Asenapine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Impact of switching to asenapine	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Predictors of successful switch to asenapine	3 months

Collaborators and Investigators

• Sponsor: Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec
• Investigators: Principal Investigator: Marc-André Roy, MD, Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): February 1, 2014
• Study Completion (Anticipated): March 1, 2014

Study Registration Dates

• First Submitted: October 16, 2013
• First Submitted That Met QC Criteria: October 22, 2013
• First Posted (Estimate): October 23, 2013

Study Record Updates

• Last Update Posted (Estimate): January 9, 2014
• Last Update Submitted That Met QC Criteria: January 8, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Schizophrenia; Disease; Schizophrenia Spectrum and Other Psychotic Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Asenapine
• Other Study ID Numbers: IIS - Switch Asenapine