Treatment With Risperidone Long Acting Injectable (RLAI) in an Early Phase of Psychosis

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research study is to see how well patients in an early phase of their illness respond to treatment and whether this depends on how well they functioned socially, academically and vocationally before becoming ill. The study also examines whether patients with more insight into their illness have better outcomes.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Diagnosis of schizophrenia/schizoaffective disorder for no longer than 2 years

• At least 2 previous psychotic episodes

• At least 6 months of antipsychotic treatment required

• maximum total Positive and Negative Symptom Score (PANSS) score of < = 80

• Patients may be currently treated with any antipsychotic (with the exception of clozapine and depot neuroleptics) at doses not exceeding the registered highest recommended dose.

Exclusion Criteria:

• Already on treatment with RLAI

• Patients requiring treatment at entry with mood stabilizers or antidepressants may enter the study only if a stable dose has been received for 3 months prior to study entry

• Previously received treatment with clozapine

• Known non-responders to previous treatment with at least 2 antipsychotics

• Mental retardation

• Patients with conditions and symptoms that are listed in the SmPC under special warnings and special precautions for use

• Acute risk of suicide in the investigator's opinion at study entry or history of suicidal attempt(s) in the last 3 months before the study entry