Official Title: “Treatment Success in Patients Requiring Treatment Change From Olanzapine to Risperidone Long Acting Injectable (TRESOR)”

The purpose of the study is to evaluate the maintained effectiveness of long-acting injectable risperidone (RISPERDAL® CONSTA™) compared with the previous treatment with oral olanzapine in non-acute subjects with schizophrenia or schizoaffective disorder considered in need of a therapy change.

Study Type: Interventional

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

Although many schizophrenia patients currently take oral antipsychotic medications, it is estimated that up to 75% of them have difficulty adhering to the daily oral regimen.

Long-acting injectable formulations may eliminate the need for daily medication and enhance patient compliance with the treatment regimen. In addition, transitioning to a different antipsychotic drug is at times a necessary step in the clinical management of patients with schizophrenia due to different reasons, including insufficient response and poor tolerability. This is an open-label, non-randomized study of a formulation of risperidone (RISPERDAL® CONSTA™) (coated microspheres) injected into the muscle at week intervals over 6 months in patients with schizophrenia or schizoaffective disorder. During the first 3 weeks, oral olanzapine treatment is continued to provide therapy until the risperidone long-acting injectable reaches effective drug levels. The oral olanzapine treatment is tapered off within 1 week for one group of patients and within 3 weeks for another group.

Assessments of effectiveness include the Positive and Negative Syndrome Scale (PANSS), overall severity of illness measured by the Clinical Global Impression (CGI) scale, and quality of life evaluated by the SF-36 questionnaire. Safety evaluations include incidence of adverse events througout the study and Exrapyramidal Symptom Rating Scale (ESRS), clinical laboratory tests (biochemistry, hematology, and urinalysis), and physical exams, including body weight, at specified intervals. The study hypothesis is that changing to treatment every 2 weeks with long-acting risperidone will provide a maintained effectiveness patients with schizophrenia or schizoaffective disorder and will be generally well-tolerated

Risperidone, long-acting formulation for intramuscular injection (25 milligrams[mg]) every 2 weeks for 6 months. Investigator may adjust dosage to 37.5mg or 50mg (maximum) or supplement risperidone injections with risperidone tablets (2mg maximum), according to symptoms and treatment response.

Intervention(s) in this Clinical Trial

• Drug: risperidone

Primary Measures

• Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score at the end of the treatment period (6 months).

Secondary Measures

• Changes from baseline to end of treatment in Clinical Global Impression-Severity of Illness, Quality of Life SF-36, patient satisfaction with treatment

Inclusion Criteria:

• Diagnosis of schizophrenia or schizoaffective disorder according to criteria of Diagnostic and StatisticalManual of Mental Diseases, 4th edition (DSM-IV)
• Patients must have been symptomatically non-acute on a stable dose of olanzapine the last month before the screening visit
• Patients must be currently treated with oral olanzapine at doses stable for the last month and willing to switch to long-acting injectable risperidone for one of the following reasons: insufficient treatment response, adverse events, compliance issues, or patient's request

Exclusion Criteria:

• Patients not treated with effective doses of olanzapine (acc. to SmPC) prior to study initiation
• Known hypersensitivity, intolerance, or unresponsiveness to risperidone
• History of drug allergy or neuroleptic malignant syndrome, a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness
• Tardive dyskinesia, a complication of neuroleptic therapy involving involuntary movements of facial muscles
• Pregnant or nursing females, or those lacking adequate contraception

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: Janssen Pharmaceutica N.V., Belgium

Overall Clinical Trial Officials and Contacts

Janssen Pharmaceutica N.V. Clinical Trial Study Director Janssen Pharmaceutica N.V., Belgium  

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00216632

Study ID Number: CR003211

ClinicalTrials.gov Identifier: NCT00216632

Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment