A Pilot Study of the Use of Risperidone Long Acting Injectable in the Treatment of Patients With Recent Onset Psychosis

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to assess the effectiveness and safety of long-acting injectable risperidone in the treatment of patients in the early stage of psychosis

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

Details

• Lead Sponsor: Janssen Pharmaceutica N.V., Belgium
• Treatments: Risperidone

Criteria

Inclusion Criteria:

• Meet the criteria of the Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV) for schizophreniform disorder, schizophrenia, or schizoaffective disorder for no longer than 12 months, and with not more than two hospitalizations for psychosis

• patients who have, during their lifetime, been exposed to a maximum of 12 weeks of antipsychotic medication

• patients who will require at least 12 months of treatment

Exclusion Criteria:

• DSM-IV axis I diagnosis other than schizophreniform disorder, schizophrenia, or schizoaffective disorder

• patients requiring treatment with mood stabilizers or antidepressants at study initiation

• alcohol or drug abuse or dependence, according to DSM-IV criteria

• history of drug allergy, drug hypersensitivity (including risperidone), or neuroleptic malignant syndrome, a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness

• previous treatment with an injectable antipsychotic medication

• pregnant or nursing females, or those lacking adequate contraception