Summary
A one year, open-label, study to evaluate the safety and tolerability of risperidone implants as a maintenance treatment in patients with schizophrenia
Description
The trial is to evaluate the 48-week safety and tolerability of risperidone implants as maintenance therapy in subjects with schizophrenia. This will be measured by the incidence of psychotic symptoms exacerbation/impending relapse, PANSS, CGI-I, CGI-S, adverse events, vital signs, clinical laboratory, physical exam and ECG findings, Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and Simpson-Angus Scale (SAS) and Investigator assessments.
Study Design
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Not sure about this one. How would they taper the dose if necessary ?