- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01888107
Maintenance of Efficacy With Risperidone Long Acting Injectable (R-LAI) in Patients With Schizophrenia or Schizoaffective Disorder
June 25, 2013 updated by: Janssen-Cilag S.p.A.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
347
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Risperidone Long-acting Injectable (LAI)
Risperidone LAI will be administered in dosages of 25, 37.5, and 50 mg.
|
Risperidone LAI will be administered as a gluteal intramuscular injection given every 2 weeks for 52 weeks.
Risperidone LAI will be administered as a gluteal intramuscular injection given every 2 weeks for 52 weeks.
Risperidone LAI will be administered as a gluteal intramuscular injection given every 2 weeks for 52 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline and after 4, 12, 26, 38 and 52 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Global Impression-Severity (CGI-S) scale
Time Frame: Baseline
|
This measure is used to evaluate disease severity at baseline (Visit 1).
|
Baseline
|
Change from Baseline in Clinical Global Impression-Change (CGI-C) scale
Time Frame: Baseline and after 4, 12, 26, 38 and 52 weeks
|
This measure is used to evaluate disease severity at the other time points (Visits 2 to 6).
|
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
|
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.
|
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
|
Personal attitude towards risperidone long-acting injectable treatment is rated by a subjective questionnaire that is administered at each study visit (1 through 6).
|
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
|
Baseline and after 4, 12, 26, 38 and 52 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Primary Completion (Actual)
April 1, 2007
Study Completion (Actual)
April 1, 2007
Study Registration Dates
First Submitted
June 25, 2013
First Submitted That Met QC Criteria
June 25, 2013
First Posted (Estimate)
June 27, 2013
Study Record Updates
Last Update Posted (Estimate)
June 27, 2013
Last Update Submitted That Met QC Criteria
June 25, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Disease
- Psychotic Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Dopamine Agents
- Serotonin Antagonists
- Dopamine Antagonists
- Risperidone
Other Study ID Numbers
- CR004993
- 2004-000830-35 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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