Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Investigator Initiated Study - Asenapine Early Psychosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01968161
Recruitment Status : Unknown
Verified January 2014 by Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec.
Recruitment status was:  Not yet recruiting
First Posted : October 23, 2013
Last Update Posted : January 9, 2014
Sponsor:
Information provided by (Responsible Party):
Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec

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.

Condition or disease Intervention/treatment Phase
Schizophrenia and Disorders With Psychotic Features Disorders Drug: Asenapine Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Switch Study to Asenapine in the Early Stage of Psychosis
Study Start Date : October 2013
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Asenapine
Open label switch to asenapine: asenapine will be introduced at the target dose (5 mg bid)
Drug: Asenapine



Primary Outcome Measures :
  1. Impact of switching to asenapine [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Predictors of successful switch to asenapine [ Time Frame: 3 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01968161


Locations
Layout table for location information
Canada
Clinique Notre-Dame des Victoires
Quebec, Canada, G1K 4B2
Contact: Diana Pasat, BSc    418-694-2223    diana.pasat@yahoo.ca   
Principal Investigator: Marc-Andre Roy, MD         
Sponsors and Collaborators
Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec
Investigators
Layout table for investigator information
Principal Investigator: Marc-André Roy, MD Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec

Layout table for additonal information
Responsible Party: Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec
ClinicalTrials.gov Identifier: NCT01968161    
Other Study ID Numbers: IIS - Switch Asenapine
First Posted: October 23, 2013    Key Record Dates
Last Update Posted: January 9, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Pathologic Processes
Mental Disorders
Asenapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs