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A Comparison of Long-acting Injectable Medications for Schizophrenia

NCT01136772 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 311

Last updated 2016-10-21

Study results available
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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).

Conditions

Interventions

DRUG

haloperidol decanoate

haloperidol decanoate injections, 25-200 mg once a month

DRUG

paliperidone palmitate

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

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Duke University

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    collaborator OTHER

  • New York State Psychiatric Institute

    lead OTHER

Principal Investigators

  • Scott Stroup, MD, MPH · Columbia University

  • Joseph P McEvoy, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2013-07-31
Completion
2016-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01136772 on ClinicalTrials.gov