Viewing Study NCT01968161


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Study NCT ID: NCT01968161
Status: UNKNOWN
Last Update Posted: 2014-01-09
First Post: 2013-10-16
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: Investigator Initiated Study - Asenapine Early Psychosis
Sponsor: Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec
Organization:

Study Overview

Official Title: An Open-label Switch Study to Asenapine in the Early Stage of Psychosis
Status: UNKNOWN
Status Verified Date: 2014-01
Last Known Status: NOT_YET_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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: None

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: