Schizophrenia and Disorders With Psychotic FeaturesPhase 4NCT01968161
Investigator Initiated Study - Asenapine Early Psychosis
A Phase 4 study testing Asenapine in people with Schizophrenia and Disorders With Psychotic Features and Disorders, run by Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia and Disorders With Psychotic Features, Disorders
- What is being tested?
- Asenapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2013to Mar 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Clinique Notre-Dame des Victoires
Québec, Quebec, G1K 4B2
Diana Pasat, BSc, 418-694-2223, diana.pasat@yahoo.ca
Marc-Andre Roy, MD
About this study
Official title: An Open-label Switch Study to Asenapine in the Early Stage of Psychosis
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.
- Being tested
- Asenapine
- Medical subject headings
- Schizophrenia Spectrum and Other Psychotic Disorders, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AsenapineDrug
| Study group | Role | What they receive |
|---|---|---|
| Asenapine | Other | Open label switch to asenapine: asenapine will be introduced at the target dose (5 mg bid) Receives: Drug: Asenapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of switching to asenapine
Measured: 3 months
Secondary outcomes (1)
Predictors of successful switch to asenapine
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionFeb 2014 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia and Disorders With Psychotic FeaturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc-André Roy, MD, Principal investigator, Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968161
- Sponsor's protocol ID
- IIS - Switch Asenapine
- Status last verified
- Jan 2014
- First submitted
- 16 Oct 2013
- Last updated
- 9 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Switch Study to Asenapine in the Early Stage of Psychosis
- ClinicalTrials.gov ID
- NCT01968161
- Acronym / sponsor ID
- IIS - Switch Asenapine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire en Santé Mentale de QuébecUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 23 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asenapine | Other | Drug: AsenapineOpen label switch to asenapine: asenapine will be introduced at the target dose (5 mg bid) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Asenapine | Drug | Asenapine |
Primary outcome
Impact of switching to asenapine
Time frame: 3 months
1 secondary outcome
Predictors of successful switch to asenapine
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc-André Roy, MD principal investigator
Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Asenapine in people with Schizophrenia and Disorders With Psychotic Features and Disorders, run by Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of switching to asenapine (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2014.