A Study of the Effectiveness and Safety of Long-acting Injectable Risperidone Versus Placebo in the Treatment of Patients With Schizophrenia

• Status: Completed
• Trial end date: 2000-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to compare the effectiveness and safety of a long-acting injectable formulation of risperidone (an antipsychotic medication) versus placebo for the treatment of the symptoms of schizophrenia over a 12-week period.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen, LP
• Treatments: Risperidone

Criteria

Inclusion Criteria:

• Diagnosis of schizophrenia, according to the Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV) criteria

• total score at study entry on the PANSS (Positive and Negative Syndrome Scale for Schizophrenia) of >=60 and <=120

• patient is otherwise healthy on the basis of a pre-trial physical examination, medical history, electrocardiogram (ECG) findings and results of clinical hematology, biochemistry, and urinalysis tests performed within 1 week of the start of risperidone treatment

• women of child-bearing age must be using an adequate method of birth control and have a negative pregnancy test before the start of risperidone treatment.

Exclusion Criteria:

• Patients receiving an injectable form of another antipsychotic (last injection within 120 days of screening)

• patients with a DSM-IV Axis I diagnosis other than schizophrenia

• DSM-IV diagnosis of substance dependence within 3 months of start of screening (nicotine and caffeine dependence are allowed)

• history or current symptoms of tardive dyskinesia (a condition seen in patients receiving long-term medication with certain types of antipsychotics in which the patients develop movements of the tongue, lips, face, trunk and hands and feet that they cannot control)

• history of neuroleptic malignant syndrome (a rare condition in patients receiving antipsychotic medication in which a patients may develop fever, sweating, unstable blood pressure, rigid muscles, and other symptoms, including changes in their normal mental state).