SchizophreniaPhase 3NCT00236353
Evaluation of the Efficacy and Safety of Risperidone Injections Given Once a Month to Adults With Schizophrenia or Schizoaffective Disorder
A Phase 3 study testing risperidone in people with Schizophrenia and Psychotic Disorders, run by Janssen, LP.
Trial summary
The purpose of this study is to assess the effectiveness and safety of long-acting risperidone given as a once monthly injection to adult patients with schizophrenia or schizoaffective disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Psychotic Disorders
- What is being tested?
- risperidone
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- May 2002to Dec 2003
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of schizophrenia or schizoaffective disorder
- stable with respect to disease symptoms and other medical conditions
- stable on antipsychotic therapy with oral risperidone 2 to 6 milligrams per day for 8 weeks before study
- if female, using birth control.
Who cannot join
- Hospitalized within 8 weeks of beginning the study
- at risk to self or others
- presence of liver or kidney damage
- use of oral antipsychotic drugs other than risperidone within the past 8 weeks, of injected antipsychotics within the past 6 months, of long-acting risperidone in an earlier study, of investigational drugs within the past 30 days, or of electroconvulsive therapy within the past 12 months
- pregnant or breast-feeding
- if female, not using birth control
- abusing drugs or alcohol.
About this study
Official title: An Open-label Study of the Efficacy and Safety of RISPERDAL Long-acting Microspheres (RISPERDAL CONSTA) Administered Once Monthly in Adults With Schizophrenia or Schizoaffective Disorder
The purpose of this study is to assess the effectiveness and safety of long-acting risperidone given as a once monthly injection to adult patients with schizophrenia or schizoaffective disorder.
Read the detailed description
Risperidone, taken by mouth on a daily basis, has been an effective treatment for schizophrenia and schizoaffective disorder. Risperidone is also available in a long-acting injectable form so that patients can take their medicine by bi-weekly injections. This study will assess the effectiveness and safety of long-acting risperidone injection given once a month instead of every two weeks (based on previous studies with dosing every 2 weeks). During the four-week lead-in phase, patients will receive one 50-milligram injection every two weeks for two doses. Patients continue to take their prescribed dose of risperidone tablets (from 2 to 6 milligrams per day) for the first 14 days. After the first month, patients will receive one 50-milligram injection once a month for 48 weeks. This dose can be increased to 75 milligrams if patient meets relapse criteria, and is willing to stay in the trial. Patients will be asked questions to help determine how well the monthly injections are working. Laboratory tests (including drug levels), physical examinations and adverse event reporting will be performed to determine the safety of the monthly injections. Risperidone oral tablets, 2 to 6 milligrams per day, for first 2 weeks; long-acting risperidone intramuscular injections, 50 mg in 2 milliliters of liquid, every 2 weeks for 1 month, then injections once a month for 48 weeks. Monthly injection dose may be increased to 75 mg in 2-mL if needed.
- Conditions
- Schizophrenia, Psychotic Disorders
- Being tested
- risperidone
- Keywords
- schizophrenia, schizoaffective disorder, long-acting risperidone, intramuscular injection
- 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.
risperidoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness measured by incidence of symptom reoccurrence (relapse) in 1 year.
Secondary outcomes (1)
Effectiveness assessed by the Clinical Global Impression Scale, Positive and Negative Syndrome Scale; safety scales are for: Extrapyramidal Symptom Rating, Abnormal Involuntary Movement, and Dickson-Glazer Sexual Functioning Inventory, and adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startMay 2002
- Study completionDec 2003
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen, LP
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Janssen, LP Clinical Trial, Study director, Janssen, LP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00236353
- Sponsor's protocol ID
- CR002830
- Status last verified
- Mar 2011
- First submitted
- 7 Oct 2005
- Last updated
- 17 May 2011
- Results posted
- No
Publications
Uchida H, Mamo DC, Kapur S, Labelle A, Shammi C, Mannaert EJ, Mann SW, Remington G. Monthly administration of long-acting injectable risperidone and striatal dopamine D2 receptor occupancy for the management of schizophrenia. J Clin Psychiatry. 2008 Aug;69(8):1281-6. doi: 10.4088/jcp.v69n0811.
PubMed 18642974
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study of the Efficacy and Safety of RISPERDAL Long-acting Microspheres (RISPERDAL CONSTA) Administered Once Monthly in Adults With Schizophrenia or Schizoaffective Disorder
- ClinicalTrials.gov ID
- NCT00236353
- Acronym / sponsor ID
- CR002830
- Conditions
- Schizophrenia, Psychotic Disorders
- Keywords
- schizophrenia, schizoaffective disorder, long-acting risperidone, intramuscular injection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Janssen, LPIndustry (pharma, biotech, devices)
- Study start
- May 2002
- Study completion
- Dec 2003 (actual)
- First posted
- 12 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 assess the effectiveness and safety of long-acting risperidone given as a once monthly injection to adult patients with schizophrenia or schizoaffective disorder.
Detailed description
Risperidone, taken by mouth on a daily basis, has been an effective treatment for schizophrenia and schizoaffective disorder. Risperidone is also available in a long-acting injectable form so that patients can take their medicine by bi-weekly injections. This study will assess the effectiveness and safety of long-acting risperidone injection given once a month instead of every two weeks (based on previous studies with dosing every 2 weeks). During the four-week lead-in phase, patients will receive one 50-milligram injection every two weeks for two doses. Patients continue to take their prescribed dose of risperidone tablets (from 2 to 6 milligrams per day) for the first 14 days. After the first month, patients will receive one 50-milligram injection once a month for 48 weeks. This dose can be increased to 75 milligrams if patient meets relapse criteria, and is willing to stay in the trial. Patients will be asked questions to help determine how well the monthly injections are working. Laboratory tests (including drug levels), physical examinations and adverse event reporting will be performed to determine the safety of the monthly injections. Risperidone oral tablets, 2 to 6 milligrams per day, for first 2 weeks; long-acting risperidone intramuscular injections, 50 mg in 2 milliliters of liquid, every 2 weeks for 1 month, then injections once a month for 48 weeks. Monthly injection dose may be increased to 75 mg in 2-mL if needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of schizophrenia or schizoaffective disorder
- stable with respect to disease symptoms and other medical conditions
- stable on antipsychotic therapy with oral risperidone 2 to 6 milligrams per day for 8 weeks before study
- if female, using birth control.
Key exclusion criteria (7 listed)
- Hospitalized within 8 weeks of beginning the study
- at risk to self or others
- presence of liver or kidney damage
- use of oral antipsychotic drugs other than risperidone within the past 8 weeks, of injected antipsychotics within the past 6 months, of long-acting risperidone in an earlier study, of investigational drugs within the past 30 days, or of electroconvulsive therapy within the past 12 months
- pregnant or breast-feeding
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 | Drug | – |
Primary outcome
Effectiveness measured by incidence of symptom reoccurrence (relapse) in 1 year.
1 secondary outcome
Effectiveness assessed by the Clinical Global Impression Scale, Positive and Negative Syndrome Scale; safety scales are for: Extrapyramidal Symptom Rating, Abnormal Involuntary Movement, and Dickson-Glazer Sexual Functioning Inventory, and adverse events
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 17 May 2011.
- Derived from this study: PubMed 18642974Uchida H, Mamo DC, Kapur S, Labelle A, Shammi C, Mannaert EJ, Mann SW, Remington G. Monthly administration of long-acting injectable risperidone and striatal dopamine D2 receptor occupancy for the management of schizophrenia. J Clin Psychiatry. 2008 Aug;69(8):1281-6. doi: 10.4088/jcp.v69n0811.
- An Open-Label Study of the Efficacy and Safety of RISPERDAL� Long-Acting Microspheres (RISPERDAL� CONSTA�) administered once monthly in Adults with Schizophrenia or Schizoaffective DisorderLink provided by the sponsor.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
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
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing risperidone in people with Schizophrenia and Psychotic Disorders, run by Janssen, LP.
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 7 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 17 May 2011. 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?
Effectiveness measured by incidence of symptom reoccurrence (relapse) in 1 year.. 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 NCT00236353, 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 17 May 2011.