SchizophreniaPhase 4NCT00313391
Risperdal Consta and Health Care Utilization in Patients With Schizophrenia
A Phase 4 study testing Risperdal Consta in people with Schizophrenia and Schizoaffective Disorder, run by Emory University at 1 site in United States.
Trial summary
The purpose of this study is to determine if Risperdal Consta will affect the healthcare utilization costs in chronically ill schizophrenic patients with multiple admissions to the psychiatric hospital compared to the previous utilization costs under standard oral treatment of any atypical antipsychotic. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Risperdal Consta
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Dec 2007
- Phase
- Phase 4
- 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
- Adult
Who may be able to join
- Primary diagnosis of schizophrenia or schizoaffective disorder
- 4 or more admissions to psychiatric hospital in past year, OR minimum of 2 hospital admissions and at least 2 incarcerations in the previous year
- Medicaid recipient
- Patients requiring concomitant non-antipsychotic psychotropic medication (mood stabilizing, antidepressants, anxiolytics)
Who cannot join
- Past or current psychiatric disorder, other than schizophrenia or schizoaffective disorder
- Drug or alcohol dependence
- Serious, unstable medical illness or any acute medical condition
- Pregnant or lactating females
- Prior Risperdal Consta treatment
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Risperdal Consta on Health Care Utilization Costs in Chronically Ill Schizophrenic Patients
The purpose of this study is to determine if Risperdal Consta will affect the healthcare utilization costs in chronically ill schizophrenic patients with multiple admissions to the psychiatric hospital compared to the previous utilization costs under standard oral treatment of any atypical antipsychotic. We hypothesize that higher Risperdal Consta acquisition costs can be offset by reduction in total medical utilization costs, such as hospitalizations, ER visits, unscheduled outpatient visits or incarcerations due to worsening of psychotic symptoms.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Risperdal Consta
- 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.
Risperdal ConstaDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2006 (estimated)
- Study startDec 2005
- Primary 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.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen, L.P. - Investigator Initiated Studies Program
- Investigators
- Dragana Bugarski-Kirola, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00313391
- Sponsor's protocol ID
- 731-2005
- Status last verified
- Sep 2014
- First submitted
- 10 Apr 2006
- Last updated
- 25 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Risperdal Consta on Health Care Utilization Costs in Chronically Ill Schizophrenic Patients
- ClinicalTrials.gov ID
- NCT00313391
- Acronym / sponsor ID
- 731-2005
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Janssen, L.P. - Investigator Initiated Studies Program
- Study start
- Dec 2005
- Primary completion
- Dec 2007 (actual)
- First posted
- 12 Apr 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 this study is to determine if Risperdal Consta will affect the healthcare utilization costs in chronically ill schizophrenic patients with multiple admissions to the psychiatric hospital compared to the previous utilization costs under standard oral treatment of any atypical antipsychotic. We hypothesize that higher Risperdal Consta acquisition costs can be offset by reduction in total medical utilization costs, such as hospitalizations, ER visits, unscheduled outpatient visits or incarcerations due to worsening of psychotic symptoms.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Primary diagnosis of schizophrenia or schizoaffective disorder
- 4 or more admissions to psychiatric hospital in past year, OR minimum of 2 hospital admissions and at least 2 incarcerations in the previous year
- Medicaid recipient
- Patients requiring concomitant non-antipsychotic psychotropic medication (mood stabilizing, antidepressants, anxiolytics)
Key exclusion criteria (6 listed)
- Past or current psychiatric disorder, other than schizophrenia or schizoaffective disorder
- Drug or alcohol dependence
- Serious, unstable medical illness or any acute medical condition
- Pregnant or lactating females
- Prior Risperdal Consta treatment
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 |
|---|---|---|
| Risperdal Consta | Drug | – |
Primary outcome
Not reported in the source record.
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 25 Sep 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.
Dragana Bugarski-Kirola, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Risperdal Consta in people with Schizophrenia and Schizoaffective Disorder, run by Emory University 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 4 inclusion and 6 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 25 Sep 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
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 25 Sep 2014.