SchizophreniaSOURCENCT00246194
Observational Study in Patients With Schizophrenia Treated With Long-Acting Risperidone Injection (RISPERDAL CONSTA)
An observational study of Schizophrenia, run by Janssen, LP at 1 site in United States.
Trial summary
The purpose of this study is to examine treatment practices of adult schizophrenia patients by their own doctors, and to assess patient outcomes when treated with long-acting risperidone injection over a two-year period of observation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- risperidone (RISPERDAL CONSTA)
- Type of treatment
- Injection or infusion
- How many people
- 532 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients diagnosed with schizophrenia
Who may be able to join
- Patients had schizophrenia (disorganized, catatonic, paranoid, residual, or undifferentiated) that met disease diagnostic criteria as defined in Diagnostic and Statistical Manual of Mental Disorders IV ([DSM-IV]
- Requiring new treatment with long-acting risperidone injectable
- Patients were cooperative, reliable, and able to complete all aspects of the protocol
Who cannot join
- Use of an investigational drug in the past 30 days
- At risk to self or others
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The SOURCE Study: Schizophrenia Outcomes-utilization, Relapse, and Clinical Evaluation: a Prospective 2-year Observational Study of Patients With Schizophrenia Who Initiate Treatment With Injectable Risperidone Long-acting Microspheres (RISPERDAL CONSTA)
The purpose of this study is to examine treatment practices of adult schizophrenia patients by their own doctors, and to assess patient outcomes when treated with long-acting risperidone injection over a two-year period of observation.
Read the detailed description
This is a 2-year, prospective (a study in which the patients are identified and then followed forward in time for the outcome of the study), multi-center (at multiple sites), longitudinal (study that involves repeated observations of the same outcomes in the same people over long periods of time), observational study (study in which the investigators/ physicians observe the patients and measure their outcomes) in adults with schizophrenia (mental disorder characterized by a breakdown of thought processes and by poor emotional responsiveness). Physicians will determine the appropriate treatment for their patients, according to their usual practice. Patients starting treatment with long-acting risperidone injection (an antipsychotic medication) and meeting all the study criteria will be enrolled in the study. They will receive a dose of 25, 37.5 or 50 mg of risperidone every 2 weeks by intramuscular injection, and continue their treatment for schizophrenia according to usual care by their physicians. Patients will be asked questions at baseline and every three months for a period of two years to assess: efficacy of the medication, how well the patient is functioning, use of healthcare resources (eg, emergency room visits and hospitalizations) patient work status, quality of life and patient satisfaction with the medicine. Safety will be monitored throughout the study duration of 2 years.
- Conditions
- Schizophrenia
- Being tested
- risperidone (RISPERDAL CONSTA)
- Keywords
- Schizophrenia, Mental disorder, DSM-IV, RISPERDAL CONSTA, Risperidone, Long-acting risperidone, Disorganized, Catatonic, Paranoid
- Medical subject headings
- Schizophrenia, Mental Disorders, Catatonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risperidone (RISPERDAL CONSTA)Drug
Also called RISPERDAL CONSTA
Long-acting injectable of risperidone given as per the prescription from the prescribing physician.
| Study group | Role | What they receive |
|---|---|---|
| Patients with schizophrenia | Long-acting injectable of risperidone given as per the prescription from the prescribing physician (Observational study). Receives: Drug: risperidone (RISPERDAL CONSTA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to 24 months in Clinical Global Impression of Severity (CGI-S) scores
The CGI-S is a 7-point scale ranging from 1 to 7 (normal, not at all ill to among the most severely ill patients), which measures disease severity in psychiatric patients. The scale is completed by physician.
Measured: Baseline (Month 0) to 24 months
Clinical Global Impression of Change (CGI-C) scores during 24 months
The CGI-C is a 7-point scale ranging from 1 to 7 (very much improved to very much worse), which is used to rate the change in the patient's illness compared to baseline. The scale assesses the patient's improvement over time. The scale is completed by physician.
Measured: 24 months
Change from baseline to 24 months in Global Assessment of Function (GAF) scores
GAF is completed by the physician. GAF is a single item rating of the patient's psychological, social, and occupational functioning on a hypothetical continuum of mental health-illness. Respondents are asked to rate the subject's lowest level of functioning in the last week. GAF scores range from 0 to 100. (0 = Inadequate information, 1 = Persistent danger of severely hurting self or others and 100 = Superior functioning in a wide range of activities).
Measured: Baseline to 24 months
Change from baseline to 24 months in Personal and Social Performance (PSP) scores
The PSP Scale is completed by the physician. PSP is a rating of a patient's level of functioning during the past month in 4 areas: (a) socially useful activities (including work and study); (b) personal and social relationships; (c) self-care; and (d) disturbing and aggressive behaviors. Scores range from 1 to 100. (1= Lack of autonomy in basic functioning and 100 = Excellent functioning in all 4 main areas).
Measured: Baseline to 24 months
Change from baseline to 24 months in Strauss-Carpenter Levels of Function (LOF) scores
The Strauss-Carpenter LOF is completed by the physician. It consists of 9 items that can be grouped into 4 subscales: symptoms (absence of symptoms and recent hospitalizations), social contacts (frequency and quality of social contacts), work (quantity and quality of useful work), and function (ability to meet basic needs, fullness of life, and overall level of function). Each item is rated on a scale of 0 (worst functioning) to 4 (best functioning).
Measured: Baseline to 24 months
Secondary outcomes (3)
Change from baseline to 24 months in Quality of Life Assessment: Medical Outcomes Survey Short Form (SF-36) scores
Patients completed the SF-36. The survey includes 36 items and evaluates health status in the past 4 weeks, in 8 different areas, which can be broadly summarized as physical health (physical functioning [PF], role-physical [RP], bodily pain [BP] and general health [GH]) and mental health (vitality [VT], social functioning [SF], role-emotional [RE], and mental health [MH]). In addition, the SF-36 evaluates health status in 2 broadly-defined areas, mental health and physical health. Higher scores represent better health status.
Measured: Baseline to 24 months
Change from baseline to 24 months in patient satisfaction with antipsychotic medication
Patients are asked a single question to evaluate patient satisfaction with their current Anti psychotic medication. The question is, "The way I feel about my current antipsychotic is:" and used a 7-point response scale from 1 to 7 (extremely dissatisfied to extremely satisfy).
Measured: Baseline to 24 months
Change from baseline to 24 months in healthcare resource utilization
Healthcare resource utilization including dates of hospitalizations (inpatient), emergency room (ER) visits, and outpatient visits, consultations with specialists and general practitioners. Relapse rates (from psychiatric hospitalizations, suicidal behavior or homicidal behavior) are also captured as resource utilization.
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 posted31 Oct 2005 (estimated)
- Study startSep 2004
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 532 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen, LP
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen, LP Clinical Trial, Study director, Janssen, LP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00246194
- Sponsor's protocol ID
- CR005035
- Other IDs
- RIS-OUT-173, RISSCH4001
- Acronym
- SOURCE
- Status last verified
- Apr 2014
- First submitted
- 28 Oct 2005
- Last updated
- 4 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Crivera C, DeSouza C, Kozma CM, Dirani RD, Mao L, Macfadden W. Resource utilization in patients with schizophrenia who initiated risperidone long-acting therapy: results from the Schizophrenia Outcomes Utilization Relapse and Clinical Evaluation (SOURCE). BMC Psychiatry. 2011 Oct 14;11:168. doi: 10.1186/1471-244X-11-168.
PubMed 21999370Macfadden W, DeSouza C, Crivera C, Kozma CM, Dirani RD, Mao L, Rodriguez SC. Assessment of effectiveness measures in patients with schizophrenia initiated on risperidone long-acting therapy: the SOURCE study results. BMC Psychiatry. 2011 Oct 14;11:167. doi: 10.1186/1471-244X-11-167.
PubMed 21999346Lambert T, Olivares JM, Peuskens J, DeSouza C, Kozma CM, Otten P, Crivera C, Jacobs A, Macfadden W, Mao L, Rodriguez SC, Dirani R, Akhras KS. Effectiveness of injectable risperidone long-acting therapy for schizophrenia: data from the US, Spain, Australia, and Belgium. Ann Gen Psychiatry. 2011 Apr 4;10:10. doi: 10.1186/1744-859X-10-10.
PubMed 21463526
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SOURCE Study: Schizophrenia Outcomes-utilization, Relapse, and Clinical Evaluation: a Prospective 2-year Observational Study of Patients With Schizophrenia Who Initiate Treatment With Injectable Risperidone Long-acting Microspheres (RISPERDAL CONSTA)
- ClinicalTrials.gov ID
- NCT00246194
- Acronym / sponsor ID
- SOURCE / CR005035
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Mental disorder, DSM-IV, RISPERDAL CONSTA, Risperidone, Long-acting risperidone, Disorganized, Catatonic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 532 participants (actual)
- Lead sponsor
- Janssen, LPIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 31 Oct 2005 (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 examine treatment practices of adult schizophrenia patients by their own doctors, and to assess patient outcomes when treated with long-acting risperidone injection over a two-year period of observation.
Detailed description
This is a 2-year, prospective (a study in which the patients are identified and then followed forward in time for the outcome of the study), multi-center (at multiple sites), longitudinal (study that involves repeated observations of the same outcomes in the same people over long periods of time), observational study (study in which the investigators/ physicians observe the patients and measure their outcomes) in adults with schizophrenia (mental disorder characterized by a breakdown of thought processes and by poor emotional responsiveness). Physicians will determine the appropriate treatment for their patients, according to their usual practice. Patients starting treatment with long-acting risperidone injection (an antipsychotic medication) and meeting all the study criteria will be enrolled in the study. They will receive a dose of 25, 37.5 or 50 mg of risperidone every 2 weeks by intramuscular injection, and continue their treatment for schizophrenia according to usual care by their physicians. Patients will be asked questions at baseline and every three months for a period of two years to assess: efficacy of the medication, how well the patient is functioning, use of healthcare resources (eg, emergency room visits and hospitalizations) patient work status, quality of life and patient satisfaction with the medicine. Safety will be monitored throughout the study duration of 2 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with schizophrenia | – | Drug: risperidone (RISPERDAL CONSTA)Long-acting injectable of risperidone given as per the prescription from the prescribing physician (Observational study). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with schizophrenia
Key inclusion criteria (3 listed)
- Patients had schizophrenia (disorganized, catatonic, paranoid, residual, or undifferentiated) that met disease diagnostic criteria as defined in Diagnostic and Statistical Manual of Mental Disorders IV ([DSM-IV]
- Requiring new treatment with long-acting risperidone injectable
- Patients were cooperative, reliable, and able to complete all aspects of the protocol
Key exclusion criteria (2 listed)
- Use of an investigational drug in the past 30 days
- At risk to self or others
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 |
|---|---|---|
| risperidone (RISPERDAL CONSTA)Also: RISPERDAL CONSTALong-acting injectable of risperidone given as per the prescription from the prescribing physician. | Drug | Patients with schizophrenia |
Primary outcome
Change from baseline to 24 months in Clinical Global Impression of Severity (CGI-S) scores
Time frame: Baseline (Month 0) to 24 months
The CGI-S is a 7-point scale ranging from 1 to 7 (normal, not at all ill to among the most severely ill patients), which measures disease severity in psychiatric patients. The scale is completed by physician.
Clinical Global Impression of Change (CGI-C) scores during 24 months
Time frame: 24 months
The CGI-C is a 7-point scale ranging from 1 to 7 (very much improved to very much worse), which is used to rate the change in the patient's illness compared to baseline. The scale assesses the patient's improvement over time. The scale is completed by physician.
Change from baseline to 24 months in Global Assessment of Function (GAF) scores
Time frame: Baseline to 24 months
GAF is completed by the physician. GAF is a single item rating of the patient's psychological, social, and occupational functioning on a hypothetical continuum of mental health-illness. Respondents are asked to rate the subject's lowest level of functioning in the last week. GAF scores range from 0 to 100. (0 = Inadequate information, 1 = Persistent danger of severely hurting self or others and 100 = Superior functioning in a wide range of activities).
Change from baseline to 24 months in Personal and Social Performance (PSP) scores
Time frame: Baseline to 24 months
The PSP Scale is completed by the physician. PSP is a rating of a patient's level of functioning during the past month in 4 areas: (a) socially useful activities (including work and study); (b) personal and social relationships; (c) self-care; and (d) disturbing and aggressive behaviors. Scores range from 1 to 100. (1= Lack of autonomy in basic functioning and 100 = Excellent functioning in all 4 main areas).
Change from baseline to 24 months in Strauss-Carpenter Levels of Function (LOF) scores
Time frame: Baseline to 24 months
The Strauss-Carpenter LOF is completed by the physician. It consists of 9 items that can be grouped into 4 subscales: symptoms (absence of symptoms and recent hospitalizations), social contacts (frequency and quality of social contacts), work (quantity and quality of useful work), and function (ability to meet basic needs, fullness of life, and overall level of function). Each item is rated on a scale of 0 (worst functioning) to 4 (best functioning).
3 secondary outcomes
Change from baseline to 24 months in Quality of Life Assessment: Medical Outcomes Survey Short Form (SF-36) scores
Time frame: Baseline to 24 months
Change from baseline to 24 months in patient satisfaction with antipsychotic medication
Time frame: Baseline to 24 months
Change from baseline to 24 months in healthcare resource utilization
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 4 Apr 2014.
- Derived from this study: PubMed 21999370Crivera C, DeSouza C, Kozma CM, Dirani RD, Mao L, Macfadden W. Resource utilization in patients with schizophrenia who initiated risperidone long-acting therapy: results from the Schizophrenia Outcomes Utilization Relapse and Clinical Evaluation (SOURCE). BMC Psychiatry. 2011 Oct 14;11:168. doi: 10.1186/1471-244X-11-168.
- Derived from this study: PubMed 21999346Macfadden W, DeSouza C, Crivera C, Kozma CM, Dirani RD, Mao L, Rodriguez SC. Assessment of effectiveness measures in patients with schizophrenia initiated on risperidone long-acting therapy: the SOURCE study results. BMC Psychiatry. 2011 Oct 14;11:167. doi: 10.1186/1471-244X-11-167.
- Derived from this study: PubMed 21463526Lambert T, Olivares JM, Peuskens J, DeSouza C, Kozma CM, Otten P, Crivera C, Jacobs A, Macfadden W, Mao L, Rodriguez SC, Dirani R, Akhras KS. Effectiveness of injectable risperidone long-acting therapy for schizophrenia: data from the US, Spain, Australia, and Belgium. Ann Gen Psychiatry. 2011 Apr 4;10:10. doi: 10.1186/1744-859X-10-10.
- The SOURCE Study: Schizophrenia Outcomes-Utilization, Relapse, and Clinical EvaluationLink provided by the sponsor.
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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, LP Clinical Trial study director
Janssen, LP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Janssen, LP at 1 site in United States.
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 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 4 Apr 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 United States. 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?
Change from baseline to 24 months in Clinical Global Impression of Severity (CGI-S) scores (time frame: Baseline (Month 0) to 24 months). The study lists 5 primary outcomes in all. 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 NCT00246194, which also lists 3 linked publications.
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 4 Apr 2014.