CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 357 enrolled
Drug / intervention
Risperidone microspheres +6 moredrug
Likely dose
Risperidone microspheres 12.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00330863
NCT00330863Phase 4Completed
CompareCT.gov

Preventing Relapse: Oral Antipsychotics Compared To Injectables: Evaluating Efficacy (PROACTIVE)

Northwell Health·interventional·Posted May 29, 2006·Updated Jul 10, 2018

In Brief

A Phase 4 clinical trial evaluating Risperidone microspheres, Risperidone, and 5 other interventions for Schizophrenia and Schizoaffective Disorder. Completed, enrolled 357 participants across 8 sites.

Detailed Summary

This study is designed to find out whether taking antipsychotic medication once every two weeks by injection compared to taking daily oral medication will help people with schizophrenia maintain better control of their symptoms.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia, Schizoaffective Disorder
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 29, 2006
Enrollment StartMay 1, 2006
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 20.1 years ago

Interventions

Risperidone microspheresdrug

Minimum dose is 12.5 mg every 2 weeks. Maximum dose is 75 mg every 2 weeks.

Risperidonedrug

Target dose is 4 mg/day.

Olanzapinedrug

Target dose is 15 mg/day.

Quetiapinedrug

Target dose is 600 mg/day.

Ziprasidonedrug

Target dose is 120 mg/day.

Aripiprazoledrug

Target dose is 20 mg/day.

Paliperidonedrug

Target dose is 6 mg/day.