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

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.

Timeline

Start

2006-01

Primary completion

2009-04

Completion

2009-04

Outcome

Missed primary endpoint

Stopped (Enrollment): “Inability to recruit number of planned patients”

registry analysis (superiority or other test); Risperidone Long-Acting Injection (LAI) vs Oral Atypical Antipsychotic; p = 0.5498; Cox proportional hazard model NCT00256997 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Amisulpride	Small molecule	—	Oral
Comparator	Aripiprazole	Other / unclassified	—	Oral
Comparator	Olanzapine	Small molecule	—	Oral
Comparator	Quetiapine	Small molecule	—	Oral
Subject	Risperidone	Other / unclassified	25 mg	Intramuscular
Subject	Risperidone	Other / unclassified	37.5 mg	Intramuscular
Subject	Risperidone	Other / unclassified	50 mg	Intramuscular

Indications