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Status unknownNCT01968161Updated Jan 9, 2014

Investigator Initiated Study - Asenapine Early Psychosis

A Phase 4 interventional study of Asenapine in Schizophrenia and Disorders With Psychotic Features and Disorders, sponsored by Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-09.

Sponsored by Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2014), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Schizophrenia and Disorders With Psychotic Features
  • Disorders
03

In context

Schizophrenia Spectrum and Other Psychotic Disorders

74 studies on the registry are indexed under Schizophrenia Spectrum and Other Psychotic Disorders; 14 are open to participants now.

This study's planned enrollment of 12 is below the median of 90 across 59 interventional studies indexed under Schizophrenia Spectrum and Other Psychotic Disorders.

Browse Schizophrenia Spectrum and Other Psychotic Disorders studies →

Lead sponsor

Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Other
    Asenapine

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

    Drug: Asenapine

Interventions

06

What researchers measure

Primary outcomes

  1. Impact of switching to asenapine

    Time frame: 3 months

Secondary outcomes

  1. Predictors of successful switch to asenapine

    Time frame: 3 months

07

Study locations

1 site
  • Clinique Notre-Dame des Victoires
    Québec, Quebec G1K 4B2, Canada
    • Diana Pasat, BSc · Contact · diana.pasat@yahoo.ca · 418-694-2223
    • Marc-Andre Roy, MD · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2013, a primary completion of Feb 2014 and a completion of Mar 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 16, 2013
First posted
Oct 23, 2013
Start
Oct 2013
Primary completionEst.
Feb 2014
CompletionEst.
Mar 2014
Last update
Jan 9, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 9, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01968161
Lead sponsor
Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec
Responsible party
Sponsor
First posted
Oct 23, 2013
Start date
Oct 2013
Primary completion
Feb 2014 (estimated)
Completion
Mar 2014 (estimated)
Last update
Jan 9, 2014

Study contacts

Marc-André Roy, MD
principal investigator · Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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