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

Phase 3

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Risperidone, long-acting injectable

• Registration Number: NCT00216580
• Lead Sponsor: Janssen Pharmaceutica N.V., Belgium

Brief 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

Detailed Description

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. This study is a pilot project to demonstrate that long-acting risperidone can be used safely and effectively in treating patients in the early stage of psychosis. It is an open-label, single-arm study in patients with recent onset of schizophrenia, schizophreniform disorder, or schizoaffective disorder. There are 3 phases: Wash-out Phase of 7 days, during which current psychotropic medications are discontinued; Oral Treatment Phase, beginning 1 week before the first injection and continuing 3 weeks thereafter, during which risperidone tablets are taken; and Long-Acting Injectable Treatment Phase, during which injections are given every 2 weeks for 24 months. Assessments of effectiveness include Positive and Negative Syndrome Scale (PANSS), a scale for the measurement of symptoms of schizophrenia; time from initiation of treatment to relapse; Calgary Depression Scale for Schizophrenia (CDSS), which assesses symptoms of major depressive disorder in patients with schizophrenia; and Clinical Global Impression (CGI) scales. Safety assessments include the incidence of adverse events and Extrapyramidal Symptom Rating Scale (ESRS) scores throughout the study; clinical laboratory tests (hematology and chemistry) and vital signs (pulse, blood pressure, temperature) at stated intervals. Risperidone oral tablets once daily (1 milligram\[mg\], 2mg, or 3mg \[maximum\]) from 1 week before first injection through 3 wks after. Risperidone injections (25mg, 37.5mg, or 50mg \[max\]) every 2 weeks for 24 months. Doses may be increased or decreased at investigator's discretion.

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-22
• Study Completion: 2006-12
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-22
• Last Update Posted: 2013-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Risperidone, long-acting injectable	Risperidone, long-acting injectable	-

Primary Outcome Measures

Name	Time	Method
Change in Positive and Negative Syndrome Scale (PANSS) from baseline to end of study

Secondary Outcome Measures

Name	Time	Method
Time from initiation of treatment to relapse; changes in Calgary Depression Scale for Schizophrenia (CDSS), Clinical Global Impression (CGI) scales, Extrapyramidal Symptom Rating Scale (ESRS) at intervals throughout study