Schizophreniae-STARNCT00774085
An Observational Study to Assess Treatment & Outcomes Data in Patients Receiving Long-Acting Injectable Risperidone
An observational study of Schizophrenia, run by Janssen Cilag N.V./S.A..
Trial summary
The purpose of this study is to assess treatment and outcomes data in patients receiving treatment with long-acting injectable risperidone. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Schizophrenia
- Type of treatment
- Injection or infusion
- How many people
- 408 participants
- Where
- No sites listed yet
- Study dates
- Nov 2004to Dec 2007
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with schizophrenia
Who may be able to join
- Patient who started long-acting injectable risperidone treatment after agreement between doctor and patient
- Ambulatory patient or not chronically full-time hospitalized patient. Full-time hospitalization at the moment of inclusion for maximal 6 months
- The treatment and treated indication according to local label
- Patient had given informed consent in agreement with local legislation
Who cannot join
- Patient participating in another medication related study, chronically full-time hospitalized patient, who according to the treating physician had no perspective of being discharged within the planned observation period
- Patient suffering from treatment resistant schizophrenia
- Pregnant or breastfeeding females or females with planned pregnancy within two years
About this study
Official title: Electronic Schizophrenia Treatment Adherence Registry
The purpose of this study is to assess treatment and outcomes data in patients receiving treatment with long-acting injectable risperidone.
Read the detailed description
This is an observational (study in which patients/participants are observed) and multicentre (at multiple sites) study. This is one-country arm of a multinational study. This study consists of 2 years of retrospective (a study in which the patients are identified and then documented backward in time and 2 years of prospective (a study in which the patients are identified and then followed forward in time for the outcome of the study) study periods during which medication utilization review will be done, determining medication usage patterns and outcomes associated with the use of risperidone long acting, in clinical practice. Usage of risperidone according to label was recommended during the study. The planned recruitment period will be 6 months. Retrospective observation will be 2 years for hospitalization history and at least 1 year for medication usage. Total duration of prospective observation for each patient with a complete follow-up will be 24 months. Data collection during the follow up period will be scheduled every 3 months ± 2 weeks. In addition, this study is proposed in Belgium to satisfy the demand from Belgian Reimbursement Authorities to collect clinical data on the impact of risperidone long acting on treatment compliance, number of hospitalizations and potential prevention of relapses. Also, this data will provide documentation on switch from oral to parenteral treatment. Data will be pooled from different physicians and/or countries. The objectives of this study are: collect clinical outcome data at the request of the Belgian Reimbursement Authorities; prospectively assess medication usage patterns to document clinical efficacy and long-term treatment outcomes of risperidone long acting, in a naturalistic setting; collect retrospective data, to compare with risperidone long acting; document reasons for initiating risperidone; collect data on switch of treatment to risperidone long acting.
- Conditions
- Schizophrenia
- Being tested
- No intervention was given
- Keywords
- Schizophrenia, Risperidone, Risperdal Consta, Propective, Retrospective, Mental disorders, Observational
- Medical subject headings
- Schizophrenia, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention was givenOther
Participants included patients treated with long-acting injectable risperidone (Risperdal Consta) in daily practice according to local label by the physicians
| Study group | Role | What they receive |
|---|---|---|
| Patients with Schizophrenia | Patients with Schizophrenia are treated with long-acting injectable risperidone (Risperdal Consta) in daily practice according to local label by the physicians Receives: Other: No intervention was given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total length of hospitalization from retrospective to prospective period
Start date, end date of full-time or partial hospitalization will be recorded both in retrospective and prospective study period.
Measured: 48 months
Secondary outcomes (4)
Change from baseline to 24 months in Clinical Global Impression (CGI) Scale scores
Patients are rated for overall severity of schizophrenia disorder using the CGI scale (7 point scale) in which 1 = Not Ill and 7 = Extremely Severe.
Measured: Baseline, (just before the first injection of long-acting injectable risperidone) to 24 months
Change from baseline to 24 months in Global Assessment of Functioning (GAF) scores
This GAF scale rates the functioning of the patient on a scale of 1 - 100 where "1 - 10" is "Persistant danger of severely hurting self or others (eg, recurrent violence) OR persistant inability to maintain personal hygiene OR serious suicidal act with clear expectations of death" and "91- 100" is "Superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his of her positive qualities. No symptoms"
Measured: Baseline to 24 months
Change from baseline to 24 months in clinical deterioration
Clinical deterioration is assessed by evaluating presence or absence of deliberate self injury, suicidal or homicidal ideation, violent behaviour, and increased need in levels of care and increase in CGI by 2 points or more. The maintenance of treatment effect is documented by the time to significant deterioration of the psychotic condition. If signs of significant deterioration occurred more than once within each 3 monthly interval, this is recorded.
Measured: Baseline, in 3-monthly intervals (± 2 weeks) for 24 months and Last visit
Change from baseline to 24 months in assessment of remission
Clinical status will be assessed by presence or absence of the following core symptoms: delusions, conceptual disorganization, hallucinatory behavior, mannerisms and posturing, unusual thought content, blunted affect, passive/apathetic social withdrawal, lack of spontaneity and flow of conversation. Score will be given for each symptom as follows: Score 1: Absent, Minimal, Mild; Score 2: Moderate, Moderately severe, Severe, Extreme. Symptomatic remission is defined as a clinical status where for each and every of the symptoms prespecified, a score of 1 can be given for duration of 6 months.
Measured: Baseline to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2008 (estimated)
- Study startNov 2004
- Primary completionDec 2007
- Study completionDec 2007
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
- Observational model
- Case only
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Cilag N.V./S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Janssen-Cilag N.V./S.A., Belgium Clinical Trial, Study director, Janssen Cilag N.V./S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00774085
- Sponsor's protocol ID
- CR003886
- Other IDs
- RISSCH4002, 2004-002448-93, 2004
- Acronym
- e-STAR
- Status last verified
- Apr 2012
- First submitted
- 16 Oct 2008
- Last updated
- 27 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Schizophrenia Treatment Adherence Registry
- ClinicalTrials.gov ID
- NCT00774085
- Acronym / sponsor ID
- e-STAR / CR003886
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Risperidone, Risperdal Consta, Propective, Retrospective, Mental disorders, Observational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- Janssen Cilag N.V./S.A.Industry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 17 Oct 2008 (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 purpose of this study is to assess treatment and outcomes data in patients receiving treatment with long-acting injectable risperidone.
Detailed description
This is an observational (study in which patients/participants are observed) and multicentre (at multiple sites) study. This is one-country arm of a multinational study. This study consists of 2 years of retrospective (a study in which the patients are identified and then documented backward in time and 2 years of prospective (a study in which the patients are identified and then followed forward in time for the outcome of the study) study periods during which medication utilization review will be done, determining medication usage patterns and outcomes associated with the use of risperidone long acting, in clinical practice. Usage of risperidone according to label was recommended during the study. The planned recruitment period will be 6 months. Retrospective observation will be 2 years for hospitalization history and at least 1 year for medication usage. Total duration of prospective observation for each patient with a complete follow-up will be 24 months. Data collection during the follow up period will be scheduled every 3 months ± 2 weeks. In addition, this study is proposed in Belgium to satisfy the demand from Belgian Reimbursement Authorities to collect clinical data on the impact of risperidone long acting on treatment compliance, number of hospitalizations and potential prevention of relapses. Also, this data will provide documentation on switch from oral to parenteral treatment. Data will be pooled from different physicians and/or countries. The objectives of this study are: collect clinical outcome data at the request of the Belgian Reimbursement Authorities; prospectively assess medication usage patterns to document clinical efficacy and long-term treatment outcomes of risperidone long acting, in a naturalistic setting; collect retrospective data, to compare with risperidone long acting; document reasons for initiating risperidone; collect data on switch of treatment to risperidone long acting.
Study design
- Observational model
- Case only
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Schizophrenia | – | Other: No intervention was givenPatients with Schizophrenia are treated with long-acting injectable risperidone (Risperdal Consta) in daily practice according to local label by the physicians |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with schizophrenia
Key inclusion criteria (4 listed)
- Patient who started long-acting injectable risperidone treatment after agreement between doctor and patient
- Ambulatory patient or not chronically full-time hospitalized patient. Full-time hospitalization at the moment of inclusion for maximal 6 months
- The treatment and treated indication according to local label
- Patient had given informed consent in agreement with local legislation
Key exclusion criteria (3 listed)
- Patient participating in another medication related study, chronically full-time hospitalized patient, who according to the treating physician had no perspective of being discharged within the planned observation period
- Patient suffering from treatment resistant schizophrenia
- Pregnant or breastfeeding females or females with planned pregnancy within two years
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 |
|---|---|---|
| No intervention was givenParticipants included patients treated with long-acting injectable risperidone (Risperdal Consta) in daily practice according to local label by the physicians | Other | Patients with Schizophrenia |
Primary outcome
Change in total length of hospitalization from retrospective to prospective period
Time frame: 48 months
Start date, end date of full-time or partial hospitalization will be recorded both in retrospective and prospective study period.
4 secondary outcomes
Change from baseline to 24 months in Clinical Global Impression (CGI) Scale scores
Time frame: Baseline, (just before the first injection of long-acting injectable risperidone) to 24 months
Change from baseline to 24 months in Global Assessment of Functioning (GAF) scores
Time frame: Baseline to 24 months
Change from baseline to 24 months in clinical deterioration
Time frame: Baseline, in 3-monthly intervals (± 2 weeks) for 24 months and Last visit
Change from baseline to 24 months in assessment of remission
Time frame: Baseline to 24 months
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 27 Apr 2012.
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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 N.V./S.A., Belgium Clinical Trial study director
Janssen Cilag N.V./S.A.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Janssen Cilag N.V./S.A..
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 3 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 27 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in total length of hospitalization from retrospective to prospective period (time frame: 48 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 27 Apr 2012.