SchizophreniaPhase 3NCT01888107
Maintenance of Efficacy With Risperidone Long Acting Injectable (R-LAI) in Patients With Schizophrenia or Schizoaffective Disorder
A Phase 3 study testing Risperidone Long-acting Injectable (LAI) 25 mg, Risperidone LAI 37.5 mg and Risperidone LAI 50 mg in people with Schizophrenia and Schizoaffective Disorder, run by Janssen-Cilag S.p.A..
Trial summary
The purpose of this study is to assess the maintenance of antipsychotic efficacy and safety of risperidone long-acting injectable (RLAI) in patients with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Risperidone Long-acting Injectable (LAI) 25 mg, Risperidone LAI 37.5 mg and Risperidone LAI 50 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 347 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Apr 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
- Required long-term antipsychotic therapy at the time of recruitment
- Symptomatically stable and taking the same dose of antipsychotic agents for at least one month before the baseline visit (considered stable if there have been no appreciable change in symptoms over the previous month, regardless of the severity of their symptoms)
- Patients or their legal representatives provided their written informed consent prior to enrollment in the study
Who cannot join
- Patients who had received clozapine during the previous 3 months
- Participated in an investigational drug trial in the previous 30 days
- Previously been shown to be either intolerant or non-responsive to risperidone therapy
- Presence of a serious unstable medical condition, such as a history or current symptoms of tardive dyskinesia or a history of neuroleptic malignant syndrome
- Pregnant or breast-feeding; female patients of childbearing potential not using adequate contraception
About this study
Official title: Maintenance of Clinical Response With Risperidone Long Acting Injectable (R-LAI) in Patients With Schizophrenia or Schizoaffective Disorder
The purpose of this study is to assess the maintenance of antipsychotic efficacy and safety of risperidone long-acting injectable (RLAI) in patients with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) or schizoaffective (a mixed psychiatric disorder relating to a complex psychotic state that has features of both schizophrenia and a mood disorder such as bipolar disorder) disorder who were receiving treatment with any antipsychotic medication and who required a long-term antipsychotic therapy. The secondary aim is to investigate prospectively (a study that starts with the present condition of a population of individuals and follows them into the future) the prevalence of patients who met standardized remission criteria (according to Andreasen et al. criteria) and the psychopathological, psychosocial and subjective predictors of achieving remission.
Read the detailed description
This is a prospective, open-label, (all people know the identity of the intervention), single-arm study conducted at 47 sites in Italy between January 2005 and April 2007. Approximately 338 patients with schizophrenia or schizoaffective disorder who were receiving treatment with any antipsychotic medication and who required a long-term antipsychotic therapy will be switched directly to RLAI without an oral risperidone run-in (the elapsed time before a trial is started when no treatment is given to patients in the study). They will be considered either not optimally treated or symptom-free. Patients will be either not hospitalized or living in residential structures at the time of the enrollment as well as throughout the study. The maximum duration of study participation will be 52 weeks. Patient safety will be monitored throughout the study.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Risperidone Long-acting Injectable (LAI) 25 mg, Risperidone LAI 37.5 mg, Risperidone LAI 50 mg
- Keywords
- Schizophrenia, Schizoaffective Disorder, Antipsychotics, Risperidone, Long-acting injectable
- 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 Injectable (LAI) 25 mgDrug
Risperidone LAI will be administered as a gluteal intramuscular injection given every 2 weeks for 52 weeks.
Risperidone LAI 37.5 mgDrug
Risperidone LAI will be administered as a gluteal intramuscular injection given every 2 weeks for 52 weeks.
Risperidone LAI 50 mgDrug
Risperidone LAI will be administered as a gluteal intramuscular injection given every 2 weeks for 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Risperidone Long-acting Injectable (LAI) | Experimental | Risperidone LAI will be administered in dosages of 25, 37.5, and 50 mg. Receives: Drug: Risperidone Long-acting Injectable (LAI) 25 mg; Drug: Risperidone LAI 37.5 mg; Drug: Risperidone LAI 50 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Positive and Negative Syndrome Scale (PANSS) total and subscales score
Maintenance= Symptom severity assessed with PANSS scale vs baseline (Total, positive, negative, general psychopathology and cognitive cluster score); Remission= percentage of patients with 8 specific items PANSS simultaneously scoring <= 3 for at least 6 months
Measured: Baseline and after 4, 12, 26, 38 and 52 weeks
Secondary outcomes (5)
Clinical Global Impression-Severity (CGI-S) scale
This measure is used to evaluate disease severity at baseline (Visit 1).
Measured: Baseline
Change from Baseline in Clinical Global Impression-Change (CGI-C) scale
This measure is used to evaluate disease severity at the other time points (Visits 2 to 6).
Measured: Baseline and after 4, 12, 26, 38 and 52 weeks
Change from Baseline in Global Assessment of Functioning (GAF)
GAF is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91-100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1-10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death. Lower scores indicate worsening.
Measured: Baseline and after 4, 12, 26, 38 and 52 weeks
Change from Baseline in Drug Attitude Inventory (DAI 30)
Personal attitude towards risperidone long-acting injectable treatment is rated by a subjective questionnaire that is administered at each study visit (1 through 6).
Measured: Baseline and after 4, 12, 26, 38 and 52 weeks
The number of patients who experience adverse events as a measure of safety and tolerability.
Measured: Baseline and after 4, 12, 26, 38 and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2013 (estimated)
- Study startJan 2005
- Primary completionApr 2007
- Study completionApr 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag S.p.A., Italy Clinical Trial, Study director, Janssen-Cilag S.p.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01888107
- Sponsor's protocol ID
- CR004993
- Other IDs
- 2004-000830-35, 2004
- Status last verified
- Jun 2013
- First submitted
- 25 Jun 2013
- Last updated
- 27 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance of Clinical Response With Risperidone Long Acting Injectable (R-LAI) in Patients With Schizophrenia or Schizoaffective Disorder
- ClinicalTrials.gov ID
- NCT01888107
- Acronym / sponsor ID
- CR004993
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Schizophrenia, Schizoaffective Disorder, Antipsychotics, Risperidone, Long-acting injectable
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- Janssen-Cilag S.p.A.Industry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 27 Jun 2013 (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 maintenance of antipsychotic efficacy and safety of risperidone long-acting injectable (RLAI) in patients with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) or schizoaffective (a mixed psychiatric disorder relating to a complex psychotic state that has features of both schizophrenia and a mood disorder such as bipolar disorder) disorder who were receiving treatment with any antipsychotic medication and who required a long-term antipsychotic therapy. The secondary aim is to investigate prospectively (a study that starts with the present condition of a population of individuals and follows them into the future) the prevalence of patients who met standardized remission criteria (according to Andreasen et al. criteria) and the psychopathological, psychosocial and subjective predictors of achieving remission.
Detailed description
This is a prospective, open-label, (all people know the identity of the intervention), single-arm study conducted at 47 sites in Italy between January 2005 and April 2007. Approximately 338 patients with schizophrenia or schizoaffective disorder who were receiving treatment with any antipsychotic medication and who required a long-term antipsychotic therapy will be switched directly to RLAI without an oral risperidone run-in (the elapsed time before a trial is started when no treatment is given to patients in the study). They will be considered either not optimally treated or symptom-free. Patients will be either not hospitalized or living in residential structures at the time of the enrollment as well as throughout the study. The maximum duration of study participation will be 52 weeks. Patient safety will be monitored throughout the study.
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 (LAI) | Experimental | Drug: Risperidone Long-acting Injectable (LAI) 25 mg, Drug: Risperidone LAI 37.5 mg, Drug: Risperidone LAI 50 mgRisperidone LAI will be administered in dosages of 25, 37.5, and 50 mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
- Required long-term antipsychotic therapy at the time of recruitment
- Symptomatically stable and taking the same dose of antipsychotic agents for at least one month before the baseline visit (considered stable if there have been no appreciable change in symptoms over the previous month, regardless of the severity of their symptoms)
- Patients or their legal representatives provided their written informed consent prior to enrollment in the study
Key exclusion criteria (5 listed)
- Patients who had received clozapine during the previous 3 months
- Participated in an investigational drug trial in the previous 30 days
- Previously been shown to be either intolerant or non-responsive to risperidone therapy
- Presence of a serious unstable medical condition, such as a history or current symptoms of tardive dyskinesia or a history of neuroleptic malignant syndrome
- Pregnant or breast-feeding; female patients of childbearing potential not using adequate contraception
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 (LAI) 25 mgRisperidone LAI will be administered as a gluteal intramuscular injection given every 2 weeks for 52 weeks. | Drug | Risperidone Long-acting Injectable (LAI) |
| Risperidone LAI 37.5 mgRisperidone LAI will be administered as a gluteal intramuscular injection given every 2 weeks for 52 weeks. | Drug | Risperidone Long-acting Injectable (LAI) |
| Risperidone LAI 50 mgRisperidone LAI will be administered as a gluteal intramuscular injection given every 2 weeks for 52 weeks. | Drug | Risperidone Long-acting Injectable (LAI) |
Primary outcome
Change from Baseline in Positive and Negative Syndrome Scale (PANSS) total and subscales score
Time frame: Baseline and after 4, 12, 26, 38 and 52 weeks
Maintenance= Symptom severity assessed with PANSS scale vs baseline (Total, positive, negative, general psychopathology and cognitive cluster score); Remission= percentage of patients with 8 specific items PANSS simultaneously scoring <= 3 for at least 6 months
5 secondary outcomes
Clinical Global Impression-Severity (CGI-S) scale
Time frame: Baseline
Change from Baseline in Clinical Global Impression-Change (CGI-C) scale
Time frame: Baseline and after 4, 12, 26, 38 and 52 weeks
Change from Baseline in Global Assessment of Functioning (GAF)
Time frame: Baseline and after 4, 12, 26, 38 and 52 weeks
Change from Baseline in Drug Attitude Inventory (DAI 30)
Time frame: Baseline and after 4, 12, 26, 38 and 52 weeks
The number of patients who experience adverse events as a measure of safety and tolerability.
Time frame: Baseline and after 4, 12, 26, 38 and 52 weeks
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 27 Jun 2013.
- Maintenance of clinical response with risperidone long-acting injectable (R-LAI) in subjects with schizophrenia or schizoaffective disorderLink 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-Cilag S.p.A., Italy Clinical Trial study director
Janssen-Cilag S.p.A.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Risperidone Long-acting Injectable (LAI) 25 mg, Risperidone LAI 37.5 mg and Risperidone LAI 50 mg in people with Schizophrenia and Schizoaffective Disorder, run by Janssen-Cilag S.p.A..
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 5 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 27 Jun 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 from Baseline in Positive and Negative Syndrome Scale (PANSS) total and subscales score (time frame: Baseline and after 4, 12, 26, 38 and 52 weeks). 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 27 Jun 2013.