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 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 Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: Risperidone

Primary Measures

• The mean change in total PANSS (Positive and Negative Syndrome Scale score) at endpoint versus baseline.

Secondary Measures

• 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.

Inclusion Criteria:

• Meet the diagnostic criteria for schizophrenia or schizoaffective disorder according to DSM-IV-TR
• Patient has been given an adequate dose of an appropriate antipsychotic for an adequate period of time prior to enrollment, but previous treatment is considered unsatisfactory due to one or more of the following reasons: lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication

Exclusion Criteria:

• A primary, active DSM-IV-TR diagnosis other than schizophrenia and schizoaffective disorder
• Relevant history or current presence of any significant and/or unstable cardiovascular, respiratory, neurological (including seizures or significant cerebrovascular), renal, hepatic, hematologic, endocrine, immunologic or other systemic disease
• Patients that are previously on concomitant use of Risperdal CONSTA
• History or current symptoms of tardive dyskinesia
• History of neuroleptic malignant syndrome (NMS)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Johnson & Johnson Taiwan Ltd

Overall Clinical Trial Officials and Contacts

Johnson & Johnson Taiwan, Ltd. Clinical Trial Study Director Johnson & Johnson Taiwan Ltd  

Overall Contact: This study is not yet recruiting patients. Please check back for future recruiting sites, or email  info1@veritasmedicine.com

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00526877

Study ID Number: CR013873

ClinicalTrials.gov Identifier: NCT00526877

Health Authority: Taiwan: Department of Health