SchizophreniaPhase 3NCT00216580
A Pilot Study of the Use of Risperidone Long Acting Injectable in the Treatment of Patients With Recent Onset Psychosis
A Phase 3 study testing Risperidone, long-acting injectable in people with Schizophrenia, run by Janssen Pharmaceutica N.V., Belgium.
Trial summary
The purpose of the study is to assess the effectiveness and safety of long-acting injectable risperidone in the treatment of patients in the early stage of psychosis Read more about this study
- Who is it for?
- Ages 16 to 45 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Risperidone, long-acting injectable
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2004to Dec 2006
- Phase
- Phase 3
- 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 16 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Meet the criteria of the Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV) for schizophreniform disorder, schizophrenia, or schizoaffective disorder for no longer than 12 months, and with not more than two hospitalizations for psychosis
- patients who have, during their lifetime, been exposed to a maximum of 12 weeks of antipsychotic medication
- patients who will require at least 12 months of treatment
Who cannot join
- DSM-IV axis I diagnosis other than schizophreniform disorder, schizophrenia, or schizoaffective disorder
- patients requiring treatment with mood stabilizers or antidepressants at study initiation
- alcohol or drug abuse or dependence, according to DSM-IV criteria
- history of drug allergy, drug hypersensitivity (including risperidone), or neuroleptic malignant syndrome, a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness
- previous treatment with an injectable antipsychotic medication
- pregnant or nursing females, or those lacking adequate contraception
About this study
Official title: An Open-label Trial of Risperidone Long-acting Injectable in the Treatment of Subjects With Recent Onset Psychosis
The purpose of the study is to assess the effectiveness and safety of long-acting injectable risperidone in the treatment of patients in the early stage of psychosis
Read the detailed description
Although many schizophrenia patients currently take oral antipsychotic medications, it is estimated that up to 75% of them have difficulty adhering to the daily oral regimen. Long-acting injectable formulations may eliminate the need for daily medication and enhance patient compliance with the treatment regimen. This study is a pilot project to demonstrate that long-acting risperidone can be used safely and effectively in treating patients in the early stage of psychosis. It is an open-label, single-arm study in patients with recent onset of schizophrenia, schizophreniform disorder, or schizoaffective disorder. There are 3 phases: Wash-out Phase of 7 days, during which current psychotropic medications are discontinued; Oral Treatment Phase, beginning 1 week before the first injection and continuing 3 weeks thereafter, during which risperidone tablets are taken; and Long-Acting Injectable Treatment Phase, during which injections are given every 2 weeks for 24 months. Assessments of effectiveness include Positive and Negative Syndrome Scale (PANSS), a scale for the measurement of symptoms of schizophrenia; time from initiation of treatment to relapse; Calgary Depression Scale for Schizophrenia (CDSS), which assesses symptoms of major depressive disorder in patients with schizophrenia; and Clinical Global Impression (CGI) scales. Safety assessments include the incidence of adverse events and Extrapyramidal Symptom Rating Scale (ESRS) scores throughout the study; clinical laboratory tests (hematology and chemistry) and vital signs (pulse, blood pressure, temperature) at stated intervals. Risperidone oral tablets once daily (1 milligram[mg], 2mg, or 3mg [maximum]) from 1 week before first injection through 3 wks after. Risperidone injections (25mg, 37.5mg, or 50mg [max]) every 2 weeks for 24 months. Doses may be increased or decreased at investigator's discretion.
- Conditions
- Schizophrenia
- Being tested
- Risperidone, long-acting injectable
- Keywords
- Schizophrenia, Intramuscular injection, Antipsychotic agents, Long-acting risperidone, Schizophreniform disorders, Schizoaffective disorder
- 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.
Risperidone, long-acting injectableDrug
| Study group | Role | What they receive |
|---|---|---|
| Risperidone, long-acting injectable | Experimental | Not described Receives: Drug: Risperidone, long-acting injectable |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Positive and Negative Syndrome Scale (PANSS) from baseline to end of study
Secondary outcomes (1)
Time from initiation of treatment to relapse; changes in Calgary Depression Scale for Schizophrenia (CDSS), Clinical Global Impression (CGI) scales, Extrapyramidal Symptom Rating Scale (ESRS) at intervals throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startFeb 2004
- Study completionDec 2006
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutica N.V., Belgium
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Pharmaceutica N.V. Clinical Trial, Study director, Janssen Pharmaceutica N.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00216580
- Sponsor's protocol ID
- CR003358
- Other IDs
- RIS-PSY-301
- Status last verified
- Mar 2013
- First submitted
- 13 Sep 2005
- Last updated
- 25 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Trial of Risperidone Long-acting Injectable in the Treatment of Subjects With Recent Onset Psychosis
- ClinicalTrials.gov ID
- NCT00216580
- Acronym / sponsor ID
- CR003358
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Intramuscular injection, Antipsychotic agents, Long-acting risperidone, Schizophreniform disorders, Schizoaffective disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Janssen Pharmaceutica N.V., BelgiumIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Study completion
- Dec 2006 (actual)
- First posted
- 22 Sep 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 the study is to assess the effectiveness and safety of long-acting injectable risperidone in the treatment of patients in the early stage of psychosis
Detailed description
Although many schizophrenia patients currently take oral antipsychotic medications, it is estimated that up to 75% of them have difficulty adhering to the daily oral regimen. Long-acting injectable formulations may eliminate the need for daily medication and enhance patient compliance with the treatment regimen. This study is a pilot project to demonstrate that long-acting risperidone can be used safely and effectively in treating patients in the early stage of psychosis. It is an open-label, single-arm study in patients with recent onset of schizophrenia, schizophreniform disorder, or schizoaffective disorder. There are 3 phases: Wash-out Phase of 7 days, during which current psychotropic medications are discontinued; Oral Treatment Phase, beginning 1 week before the first injection and continuing 3 weeks thereafter, during which risperidone tablets are taken; and Long-Acting Injectable Treatment Phase, during which injections are given every 2 weeks for 24 months. Assessments of effectiveness include Positive and Negative Syndrome Scale (PANSS), a scale for the measurement of symptoms of schizophrenia; time from initiation of treatment to relapse; Calgary Depression Scale for Schizophrenia (CDSS), which assesses symptoms of major depressive disorder in patients with schizophrenia; and Clinical Global Impression (CGI) scales. Safety assessments include the incidence of adverse events and Extrapyramidal Symptom Rating Scale (ESRS) scores throughout the study; clinical laboratory tests (hematology and chemistry) and vital signs (pulse, blood pressure, temperature) at stated intervals. Risperidone oral tablets once daily (1 milligram[mg], 2mg, or 3mg [maximum]) from 1 week before first injection through 3 wks after. Risperidone injections (25mg, 37.5mg, or 50mg [max]) every 2 weeks for 24 months. Doses may be increased or decreased at investigator's discretion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Risperidone, long-acting injectable | Experimental | Drug: Risperidone, long-acting injectable |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Meet the criteria of the Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV) for schizophreniform disorder, schizophrenia, or schizoaffective disorder for no longer than 12 months, and with not more than two hospitalizations for psychosis
- patients who have, during their lifetime, been exposed to a maximum of 12 weeks of antipsychotic medication
- patients who will require at least 12 months of treatment
Key exclusion criteria (6 listed)
- DSM-IV axis I diagnosis other than schizophreniform disorder, schizophrenia, or schizoaffective disorder
- patients requiring treatment with mood stabilizers or antidepressants at study initiation
- alcohol or drug abuse or dependence, according to DSM-IV criteria
- history of drug allergy, drug hypersensitivity (including risperidone), or neuroleptic malignant syndrome, a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness
- previous treatment with an injectable antipsychotic medication
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, long-acting injectable | Drug | Risperidone, long-acting injectable |
Primary outcome
Change in Positive and Negative Syndrome Scale (PANSS) from baseline to end of study
1 secondary outcome
Time from initiation of treatment to relapse; changes in Calgary Depression Scale for Schizophrenia (CDSS), Clinical Global Impression (CGI) scales, Extrapyramidal Symptom Rating Scale (ESRS) at intervals throughout study
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 Mar 2013.
- An open-label trial of risperidone long-acting injectable in the treatment of subjects with recent onset psychosisLink 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 Pharmaceutica N.V. Clinical Trial study director
Janssen Pharmaceutica N.V.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Risperidone, long-acting injectable in people with Schizophrenia, run by Janssen Pharmaceutica N.V., Belgium.
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 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 Mar 2013. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
What does the primary outcome measure?
Change in Positive and Negative Syndrome Scale (PANSS) from baseline to end of study. 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 25 Mar 2013.