A Study of How Long it Takes a Patient to Relapse After Switching From an Oral Antipsychotic to One of Two Doses of Long-Acting Risperidone Injections in Patients With Schizophrenia or Schizoaffective Disorder

Condition(s) targeted: Schizoaffective Disorder; Schizophrenia

Intervention: Risperidone, long-acting injectable (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

The purpose of this study is to assess the time for patients to relapse when switched from an oral antipsychotic to one of two doses of long-acting risperidone injection (shots). Risperidone has been used successfully to treat schizophrenia and schizoaffective disorder.

Official title: A 52-wk Prospective, Randomized, Double-Blind, Multicenter Study of Relapse Following Transition From Oral Antipsychotic Medication to 2 Different Doses (25 or 50 mg Every 2 Wks) of Risperidone Long-Acting Microspheres (Risperdal® CONSTA®) in Adults With Schizophrenia or Schizoaffective Disorder

Study design: Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study

Primary outcome: Risperidone effectiveness is measured by time to relapse within the 52 week period.

Secondary outcome: Effectiveness of the drug is assessed by the Clinical Global Impression Scale and Positive and Negative Syndrome Scale; safety as assessed by the Extrapyramidal Symptom Rating Scale and treatment-emergent adverse events during the 52 week period.

Detailed description: Results from studies of older long-acting injectable antipsychotics (not risperidone) show that patients tend to relapse (which means start having symptoms again) when they are given low doses. However, increasing the dose may cause more side effects. This study will measure the time to relapse during a 52-week period in patients with schizophrenia or schizoaffective disorder who are switched from an oral antipsychotic (one taken by mouth) to one of two doses of long-acting risperidone injections (shots). The patients will be assigned to a dose of either 25 or 50 milligrams per injection every 2 weeks. Patients continue to take their usual oral antipsychotic medications up to 3 weeks following the first injection. After this 3-week period, they will receive the injectable risperidone only. Patients will be asked questions at each visit to help determine the effectiveness of the drug as assessed by the Clinical Global Impression Scale and the Positive and Negative Syndrome Scale. The safety of the drug will be based on patient signs and symptoms assessed according to the Extrapyramidal Symptom Rating Scale and self-reported treatment-emergent adverse events.

Long-acting risperidone injection, 25 or 50 milligrams per injection, every 2 weeks for 52 weeks. Patients will continue to take their current oral antipsychotics for up to 3 weeks following the first injection of risperidone.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients diagnosed with schizophrenia or schizoaffective disorder

- Stable with respect to disease symptoms and other medical conditions

- Stable on any oral antipsychotic drug (except clozapine) for 4 weeks before the study

- Patients identify a relative or acquaintance who can complete a questionnaire with

additional information about the patient

- If female, using birth control

Exclusion Criteria:

- Patient is not eligible if currently hospitalized, or was treated for an acute

disease-related crisis within the past 4 weeks

- At risk to self or others

- Use of injectable antipsychotic drugs or electroconvulsive therapy within past 6

months, or currently using carbamazepineor an oral antipsychotic drug in a dose that is higher than 8 milligrams per day in risperidone equivalents, of long-acting risperidone in an earlier study, of clozapine, or use of investigational drugs within 30 days, or of electroconvulsive therapy within past 6 months

- Presence of liver or kidney damage

- History of neuroleptic malignant syndrome

- If pregnant or breast-feeding

- Not using birth control

- Abusing drugs or alcohol

A 52-week, prospective, randomized, double-blind, multicenter study of relapse following transition from oral antipsychotic medication to two different doses of risperidone long-acting microspheres in adults with schizophrenia or schizoaffective disorder

Ending date: September 2004
Last updated: March 31, 2008