SchizophreniaREALAINCT02712463
A Study to Assess the Rate of Hospitalization in Participants With Schizophrenia Treated With Antipsychotics
An observational study of Schizophrenia, run by Janssen-Cilag Ltd. at 11 sites in 2 countries.
Trial summary
The primary purpose of the study is to compare the rate of hospitalization associated with psychotic relapse in participants with schizophrenia treated one year before with oral antipsychotics and one year after with long acting injectable atypical antipsychotics. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 310 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Jul 2015to Apr 2016
- Phase
- Observational
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Participants (both gender and 18 to 55 years of age) with schizophrenia treated with oral anti-psychotics then switched to long acting Injectable anti-psychotics.
Who may be able to join
- Out-Patients with the main diagnosis of schizophrenia with Diagnostic and Statistical Manual of Mental Disorders (DSM-4 criteria)
- Only clinical records with complete information during the 2 years period selected for data analysis will be included
- Participants treated with oral antipsychotics then switched to Long Acting Injectable (LAI) due to poor adherence, lack of efficacy (no significant symptom reduction, judged by physician, at maximum recommended dose of an antipsychotic for 6 weeks), or participants choice, (Excluding for the Brazil population, when the switch has not been clearly justified or the switch has not been done during hospitalization)
- Being regularly treated with LAI atypical antipsychotics for at least 1 year after the initial use of LAI atypical antipsychotics
Who cannot join
- Participants with refractory schizophrenia (RS)
- Participants that started LAI treatment as in-patients and patients that switched to LAI during hospitalization (only for Mexican population).
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
Mexico6 sites
Study site
Durango
Study site
Hermosillo
Study site
Ixtapaluca
Study site
México
Study site
Monterrey
Study site
San Pedro Garza García
Brazil5 sites
Study site
Aracaju
Study site
Brasília
Study site
Rio de Janeiro
Study site
São José
Study site
São Paulo
About this study
Official title: A Retrospective, Observational Study to Assess the Rate of Hospitalization in Patients With Schizophrenia Treated One Year Before With Oral Antipsychotics and One Year After With Long Acting Injectable Atypical Antipsychotics - REALAI Study
The primary purpose of the study is to compare the rate of hospitalization associated with psychotic relapse in participants with schizophrenia treated one year before with oral antipsychotics and one year after with long acting injectable atypical antipsychotics.
Read the detailed description
This is a retrospective (take a look back at events that already have taken place), observational, multicenter (when more than one hospital or medical school team work on a medical research study) study to review medical records of adults with a diagnosis of Schizophrenia during the time period from 01 January 2009 through 31-December-2013 (only for Mexican population). Data will be collected from clinical practice. The medical records of participants will be screened and eligible participants data will be collected. The period of observation will span from 12 months before initial Long Acting Injectable (LAI) use and in 12 months after the initial LAIs use. The rate of hospitalization will be primarily evaluated.
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Oral antipsychotics, Long acting Injectable antipsychotics
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Schizophrenia | This is an observational study. Data will be collected from the medical records of participants diagnosed with schizophrenia and who had been on oral antipsychotics for at least one year and thereafter have been switched to Long Acting Injectable atypical antipsychotics for at least one year. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Hospitalizations in 12 Months Before Initial Long Acting Injectable anti-psychotics (LAI) use
Percentage of participants with hospitalizations due to Psychotic relapse of schizophrenia will be reported.
Measured: 12 months before initial LAI use
Percentage of Participants with Hospitalizations in 12 Months After Initial Long Acting Injectable anti-psychotics (LAI) use
Measured: 12 months after initial LAI use
Secondary outcomes (2)
Number of hospitalizations due to Psychotic Relapse of Schizophrenia
The number of hospitalizations due to Psychotic relapse of schizophrenia will be reported.
Measured: approximately 2 years
Number of Days of Hospitalization due to Psychotic Relapse of Schizophrenia
The number of days of hospitalization due to Psychotic relapse of schizophrenia will be reported.
Measured: approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study startJul 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag Ltd. Clinical Trial, Study director, Janssen-Cilag Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712463
- Sponsor's protocol ID
- CR107059
- Other IDs
- R092670SCH4039
- Acronym
- REALAI
- Status last verified
- May 2016
- First submitted
- 15 Mar 2016
- Last updated
- 24 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Observational Study to Assess the Rate of Hospitalization in Patients With Schizophrenia Treated One Year Before With Oral Antipsychotics and One Year After With Long Acting Injectable Atypical Antipsychotics - REALAI Study
- ClinicalTrials.gov ID
- NCT02712463
- Acronym / sponsor ID
- REALAI / CR107059
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Oral antipsychotics, Long acting Injectable antipsychotics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Janssen-Cilag Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 18 Mar 2016 (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.
The primary purpose of the study is to compare the rate of hospitalization associated with psychotic relapse in participants with schizophrenia treated one year before with oral antipsychotics and one year after with long acting injectable atypical antipsychotics.
Detailed description
This is a retrospective (take a look back at events that already have taken place), observational, multicenter (when more than one hospital or medical school team work on a medical research study) study to review medical records of adults with a diagnosis of Schizophrenia during the time period from 01 January 2009 through 31-December-2013 (only for Mexican population). Data will be collected from clinical practice. The medical records of participants will be screened and eligible participants data will be collected. The period of observation will span from 12 months before initial Long Acting Injectable (LAI) use and in 12 months after the initial LAIs use. The rate of hospitalization will be primarily evaluated.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Schizophrenia | – | –This is an observational study. Data will be collected from the medical records of participants diagnosed with schizophrenia and who had been on oral antipsychotics for at least one year and thereafter have been switched to Long Acting Injectable atypical antipsychotics for at least one year. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants (both gender and 18 to 55 years of age) with schizophrenia treated with oral anti-psychotics then switched to long acting Injectable anti-psychotics.
Key inclusion criteria (4 listed)
- Out-Patients with the main diagnosis of schizophrenia with Diagnostic and Statistical Manual of Mental Disorders (DSM-4 criteria)
- Only clinical records with complete information during the 2 years period selected for data analysis will be included
- Participants treated with oral antipsychotics then switched to Long Acting Injectable (LAI) due to poor adherence, lack of efficacy (no significant symptom reduction, judged by physician, at maximum recommended dose of an antipsychotic for 6 weeks), or participants choice, (Excluding for the Brazil population, when the switch has not been clearly justified or the switch has not been done during hospitalization)
- Being regularly treated with LAI atypical antipsychotics for at least 1 year after the initial use of LAI atypical antipsychotics
Key exclusion criteria (2 listed)
- Participants with refractory schizophrenia (RS)
- Participants that started LAI treatment as in-patients and patients that switched to LAI during hospitalization (only for Mexican population).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants with Hospitalizations in 12 Months Before Initial Long Acting Injectable anti-psychotics (LAI) use
Time frame: 12 months before initial LAI use
Percentage of participants with hospitalizations due to Psychotic relapse of schizophrenia will be reported.
Percentage of Participants with Hospitalizations in 12 Months After Initial Long Acting Injectable anti-psychotics (LAI) use
Time frame: 12 months after initial LAI use
2 secondary outcomes
Number of hospitalizations due to Psychotic Relapse of Schizophrenia
Time frame: approximately 2 years
Number of Days of Hospitalization due to Psychotic Relapse of Schizophrenia
Time frame: approximately 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2016.
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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.
Janssen-Cilag Ltd. Clinical Trial study director
Janssen-Cilag Ltd.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Janssen-Cilag Ltd. at 11 sites in 2 countries.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 24 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Mexico, Brazil. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Hospitalizations in 12 Months Before Initial Long Acting Injectable anti-psychotics (LAI) use (time frame: 12 months before initial LAI use). The study lists 2 primary outcomes in all. 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 24 May 2016.