Investigator Initiated Study - Asenapine Early Psychosis

NCT01968161 | Unknown Phase 4

• 1 other identifier: IIS - Switch Asenapine
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia and Disorders With Psychotic Features; Disorders

Outcome Measures

Primary Outcomes (1)

• Impact of switching to asenapine

  3 months

Secondary Outcomes (1)

• Predictors of successful switch to asenapine

  3 months

Study Arms (1)

Asenapine

OTHER

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

Drug: Asenapine

Interventions

Asenapine DRUG

Asenapine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec: lead

Study Sites (1)

Clinique Notre-Dame des Victoires

Québec, Quebec, G1K 4B2, Canada

Location

MeSH Terms

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders; Disease

Interventions

asenapine

Condition Hierarchy (Ancestors)

Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marc-André Roy, MD

  Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2013
• First Posted: October 23, 2013
• Study Start: October 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: March 1, 2014
• Last Updated: January 9, 2014

Record last verified: 2014-01

Locations

CA (1)