A Study of the Effectiveness and Safety of Long Acting Risperidone in Patients With Schizophrenia or Schizoaffective Disorders Who Are Receiving Psychiatric Home Care Treatment
The purpose of this study is to evaluate the maintained effectiveness and improvement of overall functionality with two-week interval injections of long acting risperidone microspheres on patients receiving psychiatric homecare treatment with schizophrenia and schizoaffective disorders.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of Efficacy and Safety of Long-acting Risperidone Microspheres in Patients With Schizophrenia or Schizoaffective Disorders, Who is Receiving Psychiatric Home-care Treatment, When Switching From Typical Depot or Oral Antipsychotics to Long-acting Risperidone Microspheres|
- The mean change in total PANSS (Positive and Negative Syndrome Scale score) at endpoint versus baseline.
- Compare the PSP (Personal and Social Performance) score, CGI (Clinical Global Impression) score and SQLS (Quality of Life) at endpoint versus the baseline and pre-risperidone long acting period.
|Study Start Date:||May 2007|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
1. This is a six-month, non-randomised, single arm, multi-center study, which is aimed to evaluate effectiveness and safety in patients with schizophrenia or schizoaffective disorder who are switched from an antipsychotic medication to two-week interval injections of long acting risperidone microspheres. Patients from any antipsychotic medication can be switched to long acting risperidone microspheres without prior oral risperidone run in phase. Patients must be receiving psychiatric home-care treatment. For patients treated with oral antipsychotics before entering this study, they will stay on their previous medication for the first three weeks of risperidone microsphere treatment and the previous medication will be tapered off. On the other hand, patients previously treated with conventional depot antipsychotics will be administer risperidone microsphere instead of the previous conventional depot at the next scheduled injection date without any oral antipsychotics coverage. It is recommended to establish tolerability with oral risperidone prior to initiating treatment with risperidone long acting injectable microspheres in those patients who have no history of risperidone use. Those patients should receive 1mg risperidone tablets once daily for 2 days prior to the first risperidone depot microsphere injection. For patients previously taking anticholinergic medication, continue the anticholinergic medication as long as the antipsychotic associated with EPS (Extrapyramidal symptom) is being taken and then taper and discontinue the anticholinergic medication over the first 3 weeks after the antipsychotic is discontinued. Study medication must be administered by intramuscular (gluteal) injection every two weeks. Most patients should be started on 25 mg long acting risperidone microspheres. However, some patients (e.g. who suffer from persistent symptoms and/or are known to respond only to higher dosages of antipsychotics) may require a higher initial dose of long acting risperidone microspheres. Efficacy failure will only be considered for patients who have received the maximum dose of 50 mg long-acting risperidone microspheres and are still symptomatic or have not responded to treatment after at least 2 months on said dose (4 doses). Risperidone microspheres 25, 37.5 and 50 mg will be used for this trial. Assessments of effectiveness and safety will be performed at baseline and on months 1, 3, and 6.
The treatment will consist of vials containing risperidone (25mg, 50mg or 75 mg) long-acting formulation for intramuscular injection. Long acting risperidone microspheres must be administered by intramuscular (gluteal) injection every two weeks for six months.