CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 311 enrolled
Drug / intervention
haloperidol decanoate +1 moredrug
Likely dose
haloperidol decanoate 200 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/NCT01136772
NCT01136772Phase 4Completed

A Comparison of Long-Acting Injectable Medications for Schizophrenia

New York State Psychiatric Institute·interventional·Posted Jun 3, 2010·Updated Oct 21, 2016

In Brief

A Phase 4 clinical trial evaluating haloperidol decanoate and paliperidone palmitate for Schizophrenia and Schizoaffective Disorder. Completed, enrolled 311 participants across 22 sites.

Detailed Summary

The purpose of this research study is to compare the "real-world" effectiveness of two FDA-approved and widely used long-acting injectable antipsychotic medications (paliperidone palmitate and haloperidol decanoate) in patients with schizophrenia or schizoaffective disorder who are expected to benefit from the improved medication compliance associated with injectable medications. The goal is to evaluate the effects of the medications on outcomes of importance to patients (relapse, symptoms, adverse effects, functioning) as well as policy makers (all of the above plus costs).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 3, 2010
Enrollment StartMar 1, 2011
Primary CompletionJul 1, 2013
Study CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 16.1 years ago

Interventions

haloperidol decanoatedrug

haloperidol decanoate injections, 25-200 mg once a month

paliperidone palmitatedrug

Paliperidone palmitate injections, 39 mg - 234 mg once a month