Clinical trial NCT01888107: Maintenance of Efficacy With Risperidone Long Acting Injectable (R-LAI) in Patients With Schizophrenia or Schizoaffective Disorder
Official title: Maintenance of Clinical Response With Risperidone Long Acting Injectable (R-LAI) in Patients With Schizophrenia or Schizoaffective Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Schizophrenia
Schizoaffective Disorder
Antipsychotics
Risperidone
Long-acting injectable
Lead sponsor: Janssen-Cilag S.p.A.
Sponsor class: INDUSTRY
First posted: 2013-06-27
Enrollment: 347
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Change from Baseline in Positive and Negative Syndrome Scale (PANSS) total and subscales score
timeFrame: Baseline and after 4, 12, 26, 38 and 52 weeks
Secondary outcomes:
measure: Clinical Global Impression-Severity (CGI-S) scale
timeFrame: Baseline
measure: Change from Baseline in Clinical Global Impression-Change (CGI-C) scale
timeFrame: Baseline and after 4, 12, 26, 38 and 52 weeks
measure: Change from Baseline in Global Assessment of Functioning (GAF)
timeFrame: Baseline and after 4, 12, 26, 38 and 52 weeks
measure: Change from Baseline in Drug Attitude Inventory (DAI 30)
timeFrame: Baseline and after 4, 12, 26, 38 and 52 weeks
measure: The number of patients who experience adverse events as a measure of safety and tolerability.
timeFrame: Baseline and after 4, 12, 26, 38 and 52 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Janssen-Cilag S.p.A.
name: Janssen-Cilag S.p.A., Italy Clinical Trial
role: STUDY_DIRECTOR
References: