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Investigator Initiated Study - Asenapine Early Psychosis

Primary Purpose

Schizophrenia and Disorders With Psychotic Features, Disorders

Status
Unknown status
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Asenapine
Sponsored by
Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia and Disorders With Psychotic Features

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Clinique Notre-Dame des Victoires

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Asenapine

Arm Description

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

Outcomes

Primary Outcome Measures

Impact of switching to asenapine

Secondary Outcome Measures

Predictors of successful switch to asenapine

Full Information

First Posted
October 16, 2013
Last Updated
January 8, 2014
Sponsor
Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec
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1. Study Identification

Unique Protocol Identification Number
NCT01968161
Brief Title
Investigator Initiated Study - Asenapine Early Psychosis
Official Title
An Open-label Switch Study to Asenapine in the Early Stage of Psychosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
March 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia and Disorders With Psychotic Features, Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Asenapine
Arm Type
Other
Arm Description
Open label switch to asenapine: asenapine will be introduced at the target dose (5 mg bid)
Intervention Type
Drug
Intervention Name(s)
Asenapine
Primary Outcome Measure Information:
Title
Impact of switching to asenapine
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Predictors of successful switch to asenapine
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc-André Roy, MD
Organizational Affiliation
Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Notre-Dame des Victoires
City
Quebec
ZIP/Postal Code
G1K 4B2
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Pasat, BSc
Phone
418-694-2223
Email
diana.pasat@yahoo.ca
First Name & Middle Initial & Last Name & Degree
Marc-Andre Roy, MD

12. IPD Sharing Statement

Learn more about this trial

Investigator Initiated Study - Asenapine Early Psychosis

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