SchizophreniaNCT00644852
Medical Chart Review of Patients on Long-term Treatment With Long-acting Injectable Risperidone
An observational study of Schizophrenia and Schizoaffective Disorder, run by Johnson & Johnson Taiwan Ltd.
Trial summary
The purpose of the study is to evaluate the characteristics, clinical responses, and safety issues of patients receiving long-term treatment of Risperidone long-acting injectable. The goal is to evaluate patient outcomes based on pre-existing risk or disease factors and past medication use. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Retrospective chart review study
- How many people
- 342 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Sep 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: This study will enroll patients with diagnosis of Schizophrenia or Schizoaffective disorder by DSM-IV-TR criteria and who have ever been treated with risperidone long-acting injectable for more than 3 months.
Who may be able to join
- Diagnosis of Schizophrenia or Schizoaffective disorder by DSM-IV-TR criteria
- Patients who used to be treated with Risperidone long-acting injectable regularly for at least 3 months
- Patients whose medical charts or other medical records are available
Who cannot join
- None
About this study
The purpose of the study is to evaluate the characteristics, clinical responses, and safety issues of patients receiving long-term treatment of Risperidone long-acting injectable. The goal is to evaluate patient outcomes based on pre-existing risk or disease factors and past medication use.
Read the detailed description
This is an Observational, retrospective study on the use of Risperidone long-acting injectable. The purpose of the study is to evaluate the characteristics, clinical responses, and safety issues of patients receiving long-term treatment of Risperidone. Patient outcomes will be evaluated based on pre-existing risk or disease factors and past medication use. Data will be collected from medical charts and other available medical records from one year prior to risperidone treatment until discontinuation of risperidone long acting injectable. The study will compare the number of days hospitalized for reasons relating to psychosis before and after treatment with risperidone long-acting injectable. Information about past use of anti-psychotic medications will be collected. The occurrence and frequency of adverse events [Extra-Pyramidal Symptoms (EPS) - the abnormal body movements sometimes associated with antipsychotic medications, body weight changes, drowsiness, sexual problems] and the dose or change in dose of Risperidone long-acting injectable will also be collected. The study will also investigate the relapse rate and the hospitalization rate before and after treatment. It is a chart review type of study. No study drug has been used in the study.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Retrospective chart review study
- Keywords
- Schizophrenia, Schizoaffective disorder, Risperidone long-acting injectable, Long-term evaluation
- 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.
Retrospective chart review studyOther
Retrospective study chart review long acting risperidone
| Study group | Role | What they receive |
|---|---|---|
| 001 | Not described Receives: Other: Retrospective chart review study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the number of days hospitalized for reasons relating to psychosis before and after treatment with risperidone long-acting injectable.
Measured: From one year prior to risperidone treatment until discontinuation of risperidone long acting injectable.
Secondary outcomes (1)
Compare the Relapse Rate and the Hospitalization Rate before patients were treated with risperidone long-acting injectable
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2008 (estimated)
- Study startJan 2007
- Primary completionSep 2007
- Study completionSep 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Taiwan Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Taiwan, Ltd. Clinical Trial, Study director, Johnson & Johnson Taiwan Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00644852
- Sponsor's protocol ID
- CR013993
- Status last verified
- May 2014
- First submitted
- 24 Mar 2008
- Last updated
- 23 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Chart Review of Patients on Long-term Treatment With Long-acting Injectable Risperidone
- ClinicalTrials.gov ID
- NCT00644852
- Acronym / sponsor ID
- CR013993
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Schizophrenia, Schizoaffective disorder, Risperidone long-acting injectable, Long-term evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- Johnson & Johnson Taiwan LtdIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 27 Mar 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 the study is to evaluate the characteristics, clinical responses, and safety issues of patients receiving long-term treatment of Risperidone long-acting injectable. The goal is to evaluate patient outcomes based on pre-existing risk or disease factors and past medication use.
Detailed description
This is an Observational, retrospective study on the use of Risperidone long-acting injectable. The purpose of the study is to evaluate the characteristics, clinical responses, and safety issues of patients receiving long-term treatment of Risperidone. Patient outcomes will be evaluated based on pre-existing risk or disease factors and past medication use. Data will be collected from medical charts and other available medical records from one year prior to risperidone treatment until discontinuation of risperidone long acting injectable. The study will compare the number of days hospitalized for reasons relating to psychosis before and after treatment with risperidone long-acting injectable. Information about past use of anti-psychotic medications will be collected. The occurrence and frequency of adverse events [Extra-Pyramidal Symptoms (EPS) - the abnormal body movements sometimes associated with antipsychotic medications, body weight changes, drowsiness, sexual problems] and the dose or change in dose of Risperidone long-acting injectable will also be collected. The study will also investigate the relapse rate and the hospitalization rate before and after treatment. It is a chart review type of study. No study drug has been used in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | – | Other: Retrospective chart review study |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will enroll patients with diagnosis of Schizophrenia or Schizoaffective disorder by DSM-IV-TR criteria and who have ever been treated with risperidone long-acting injectable for more than 3 months.
Key inclusion criteria (3 listed)
- Diagnosis of Schizophrenia or Schizoaffective disorder by DSM-IV-TR criteria
- Patients who used to be treated with Risperidone long-acting injectable regularly for at least 3 months
- Patients whose medical charts or other medical records are available
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Retrospective chart review studyRetrospective study chart review long acting risperidone | Other | 001 |
Primary outcome
Compare the number of days hospitalized for reasons relating to psychosis before and after treatment with risperidone long-acting injectable.
Time frame: From one year prior to risperidone treatment until discontinuation of risperidone long acting injectable.
1 secondary outcome
Compare the Relapse Rate and the Hospitalization Rate before patients were treated with risperidone long-acting injectable
Time frame: 1 year
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 23 May 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.
Johnson & Johnson Taiwan, Ltd. Clinical Trial study director
Johnson & Johnson Taiwan Ltd
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Schizoaffective Disorder, run by Johnson & Johnson Taiwan Ltd.
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 3 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 23 May 2014. 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?
Compare the number of days hospitalized for reasons relating to psychosis before and after treatment with risperidone long-acting injectable. (time frame: From one year prior to risperidone treatment until discontinuation of risperidone long acting injectable.). 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 23 May 2014.