Status:
COMPLETED
Maintenance of Efficacy With Risperidone Long Acting Injectable (R-LAI) in Patients With Schizophrenia or Schizoaffective Disorder
Lead Sponsor:
Janssen-Cilag S.p.A.
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 sympt...
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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
347 Patients enrolled
Trial Details
Trial ID
NCT01888107
Start Date
January 1 2005
End Date
April 1 2007
Last Update
June 27 2013
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.