Investigator Initiated Study - Asenapine Early Psychosis

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01968161

Enrollment

Registered

2013-10-23

Start date

2013-10-31

Completion date

2014-03-31

Last updated

2014-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disorders, Schizophrenia and Disorders With Psychotic Features

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.

Interventions

DRUGAsenapine

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Impact of switching to asenapine	3 months

Secondary

Measure	Time frame
Predictors of successful switch to asenapine	3 months

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026