Maintenance of Efficacy With Risperidone Long Acting Injectable (R-LAI) in Patients With Schizophrenia or Schizoaffective Disorder
Information source: Janssen-Cilag S.p.A.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia; Schizoaffective Disorder
Intervention: Risperidone Long-acting Injectable (LAI) 25 mg (Drug); Risperidone LAI 37.5 mg (Drug); Risperidone LAI 50 mg (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Janssen-Cilag S.p.A. Official(s) and/or principal investigator(s): Janssen-Cilag S.p.A., Italy Clinical Trial, Study Director, Affiliation: Janssen-Cilag S.p.A.
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 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.
Clinical Details
Official title: Maintenance of Clinical Response With Risperidone Long Acting Injectable (R-LAI) in Patients With Schizophrenia or Schizoaffective Disorder
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change from Baseline in Positive and Negative Syndrome Scale (PANSS) total and subscales score
Secondary outcome: Clinical Global Impression-Severity (CGI-S) scaleChange from Baseline in Clinical Global Impression-Change (CGI-C) scale Change from Baseline in Global Assessment of Functioning (GAF) Change from Baseline in Drug Attitude Inventory (DAI 30) The number of patients who experience adverse events as a measure of safety and tolerability.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Maintenance of clinical response with risperidone long-acting injectable (R-LAI) in subjects with schizophrenia or schizoaffective disorder
Starting date: January 2005
Last updated: June 25, 2013
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