SchizophreniaNCT00283517
A Registry of Treatment Adherence for Patients With Schizophrenia
An observational study of Schizophrenia and Psychotic Disorders, run by Janssen-Cilag, S.A..
Trial summary
The purpose of the study is to assess demographic, treatment, and outcome data in schizophrenia patients receiving treatment with long-acting injectable, tablet, or liquid formulations of first generation (conventional) or second generation (atypical) antipsychotic medications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Psychotic Disorders
- What is being tested?
- antipsychotics
- How many people
- 2,046 participants
- Where
- No sites listed yet
- Study dates
- Sep 2003to May 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients starting treatment with a new antipsychotic medication, in accordance with product labeling in the local area; permitted by their physician to participate in a clinical trial
Who may be able to join
- Patients starting treatment with a new antipsychotic medication, in accordance with product labeling in the local country
- Permitted by their physician and by the patient to participate in a clinical trial
Who cannot join
- Patients not meeting all of the inclusion criteria for entry into the study
About this study
Official title: Electronic Schizophrenia Treatment Adherence Registry, eSTAR
The purpose of the study is to assess demographic, treatment, and outcome data in schizophrenia patients receiving treatment with long-acting injectable, tablet, or liquid formulations of first generation (conventional) or second generation (atypical) antipsychotic medications.
Read the detailed description
Recent studies have suggested the superior effectiveness of second generation (atypical) antipsychotic medications over first generation (conventional) antipsychotics in preventing relapse during the treatment of schizophrenia. It is estimated that a majority of patients with schizophrenia have difficulty adhering to the daily regimen of oral medications, and the use of long-acting injectable antipsychotics has been shown to increase compliance. This study includes both retrospective and prospective observations of the treatments and outcomes associated with antipsychotic drug therapy as well as characteristics of the patient population. The study is not product specific and includes patients using therapy with long-acting injectable, tablet, or liquid formulations of conventional or atypical antipsychotic medications. All patients who enroll in the study start treatment with a new antipsychotic medication, which is to be used according to the product labeling in the local country. Retrospective data, collected over a minimum of 12 months, include patient diagnosis, age, sex, history of treatment with antipsychotic medications, hospitalization, Clinical Global Impression of severity of disease (CGI-severity), Global Assessment of Functioning (GAF), and the reason for starting a new antipsychotic treatment. Prospective data, collected every 3 months over 2 years, are evaluated to assess the effectiveness of treatment and include the patient's adherence to antipsychotic medication, CGI-severity, GAF, and clinical deterioration of the patient's condition. The study investigator enters the data into a registry either electronically or on paper record forms. Safety assessments include the incidence, type and severity of adverse events throughout the prospective phase of the study. Atypical or conventional antipsychotics, as tablet, liquid or injectable formulations as prescribed
- Conditions
- Schizophrenia, Psychotic Disorders
- Being tested
- antipsychotics
- Keywords
- Risperidone long-acting injection, Antipsychotic medication, Schizophrenia, Treatment retention, Observational study
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antipsychoticsDrug
as prescribed
| Study group | Role | What they receive |
|---|---|---|
| 001 | Not described Receives: Drug: antipsychotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess demographic, treatment, and outcome data in schizophrenia patients receiving treatment with long-acting injectable, tablet, or liquid formulations of first generation (conventional) or second generation (atypical) antipsychotics medications.
Measured: every 3 months over 2 years
Secondary outcomes (1)
Safety assessments include the incidence, type and severity of adverse events throughout the prospective phase of the study.
Measured: every 3 months over 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2006 (estimated)
- Study startSep 2003
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,046 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial, Study director, Janssen-Cilag, S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00283517
- Sponsor's protocol ID
- CR005548
- Status last verified
- Apr 2010
- First submitted
- 27 Jan 2006
- Last updated
- 27 Apr 2010
- Results posted
- No
Publications
Lambert T, Emmerson B, Hustig H, Resseler S, Jacobs A, Butcher B; e-STAR Research Group. Long acting risperidone in Australian patients with chronic schizophrenia: 24-month data from the e-STAR database. BMC Psychiatry. 2012 Mar 26;12:25. doi: 10.1186/1471-244X-12-25.
PubMed 22448928
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Schizophrenia Treatment Adherence Registry, eSTAR
- ClinicalTrials.gov ID
- NCT00283517
- Acronym / sponsor ID
- CR005548
- Conditions
- Schizophrenia, Psychotic Disorders
- Keywords
- Risperidone long-acting injection, Antipsychotic medication, Schizophrenia, Treatment retention, Observational study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,046 participants (actual)
- Lead sponsor
- Janssen-Cilag, S.A.Industry (pharma, biotech, devices)
- Study start
- Sep 2003
- Study completion
- May 2006 (actual)
- First posted
- 30 Jan 2006 (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 the study is to assess demographic, treatment, and outcome data in schizophrenia patients receiving treatment with long-acting injectable, tablet, or liquid formulations of first generation (conventional) or second generation (atypical) antipsychotic medications.
Detailed description
Recent studies have suggested the superior effectiveness of second generation (atypical) antipsychotic medications over first generation (conventional) antipsychotics in preventing relapse during the treatment of schizophrenia. It is estimated that a majority of patients with schizophrenia have difficulty adhering to the daily regimen of oral medications, and the use of long-acting injectable antipsychotics has been shown to increase compliance. This study includes both retrospective and prospective observations of the treatments and outcomes associated with antipsychotic drug therapy as well as characteristics of the patient population. The study is not product specific and includes patients using therapy with long-acting injectable, tablet, or liquid formulations of conventional or atypical antipsychotic medications. All patients who enroll in the study start treatment with a new antipsychotic medication, which is to be used according to the product labeling in the local country. Retrospective data, collected over a minimum of 12 months, include patient diagnosis, age, sex, history of treatment with antipsychotic medications, hospitalization, Clinical Global Impression of severity of disease (CGI-severity), Global Assessment of Functioning (GAF), and the reason for starting a new antipsychotic treatment. Prospective data, collected every 3 months over 2 years, are evaluated to assess the effectiveness of treatment and include the patient's adherence to antipsychotic medication, CGI-severity, GAF, and clinical deterioration of the patient's condition. The study investigator enters the data into a registry either electronically or on paper record forms. Safety assessments include the incidence, type and severity of adverse events throughout the prospective phase of the study. Atypical or conventional antipsychotics, as tablet, liquid or injectable formulations as prescribed
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | – | Drug: antipsychotics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients starting treatment with a new antipsychotic medication, in accordance with product labeling in the local area; permitted by their physician to participate in a clinical trial
Key inclusion criteria (2 listed)
- Patients starting treatment with a new antipsychotic medication, in accordance with product labeling in the local country
- Permitted by their physician and by the patient to participate in a clinical trial
Key exclusion criteria (1 listed)
- Patients not meeting all of the inclusion criteria for entry into the study
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 |
|---|---|---|
| antipsychoticsas prescribed | Drug | 001 |
Primary outcome
To assess demographic, treatment, and outcome data in schizophrenia patients receiving treatment with long-acting injectable, tablet, or liquid formulations of first generation (conventional) or second generation (atypical) antipsychotics medications.
Time frame: every 3 months over 2 years
1 secondary outcome
Safety assessments include the incidence, type and severity of adverse events throughout the prospective phase of the study.
Time frame: every 3 months over 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 27 Apr 2010.
- Derived from this study: PubMed 22448928Lambert T, Emmerson B, Hustig H, Resseler S, Jacobs A, Butcher B; e-STAR Research Group. Long acting risperidone in Australian patients with chronic schizophrenia: 24-month data from the e-STAR database. BMC Psychiatry. 2012 Mar 26;12:25. doi: 10.1186/1471-244X-12-25.
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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 S.A. (formerly Janssen Sp) Clinical Trial study director
Janssen-Cilag, S.A.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Psychotic Disorders, run by Janssen-Cilag, 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 2 inclusion and 1 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 2010. 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?
To assess demographic, treatment, and outcome data in schizophrenia patients receiving treatment with long-acting injectable, tablet, or liquid formulations of first generation (conventional) or second generation (atypical) antipsychotics medications. (time frame: every 3 months over 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00283517, which also lists 1 linked publication.
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 2010.