Overview

A Study of Risperidone Long-Acting Injection Versus Oral Antipsychotics in Schizophrenia Participants With a History of Being Poorly Compliant With Taking Their Medication

Status:
Terminated

Trial end date:
2009-04-01

Target enrollment:
0

Participant gender:
All

Summary

The purpose of this study is to evaluate risperidone long-acting injection (an antipsychotic medication) versus oral antipsychotics in schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) participants with a history of being poorly compliant with taking their medication.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Janssen-Ortho Inc., Canada

Treatments:

Antipsychotic Agents
Risperidone

Criteria

Inclusion Criteria: - Diagnosis of schizophrenia (psychiatric disorder with symptoms of
emotional instability, detachment from reality, often with delusions and hallucinations,
and withdrawal into the self) as per Diagnostic and Statistical Manual of Mental Disorders,
Fourth Edition Text revision (DSM-IV TR)- Have had at least 2 hospitalizations or 2
clinical worsening of symptoms, over the past 2 years because of deteriorating adherence -
Is currently receiving treatment with an antipsychotic per local product label guidelines,
and has a history in the last 5 years of a satisfactory response (minimum of 6 weeks) to
oral antipsychotics (excluding clozapine) - On monotherapy antipsychotic treatment as per
local product label guidelines, at Baseline -Female participants must be surgically
sterile, or practicing an effective method of birth control before entry and throughout the
study, and have a negative urine pregnancy test at screening before study entry Exclusion
Criteria: - Participants with a primary DSM-IV TR Axis I diagnosis other than schizophrenia
- Female participants who are currently pregnant or breastfeeding or planning a pregnancy
within 2 years of trial start - Have a serious, unstable and untreated medical illnesses,
such as vascular or cardiovascular disease, history of liver or kidney disease, significant
cardiac (having to do with the heart), pulmonary (having to do with the lungs),
gastrointestinal, endocrine, neurological (pertaining to the nervous system) or metabolic
disturbances - At significant risk of suicide or violence at study start - Evidence of
substance dependence (except for nicotine and caffeine dependence) according to DSM-IV TR
criteria diagnosed in the last month prior to entry