A Comparison of Long-acting Injectable Medications for Schizophrenia

Phase 4

Completed

Conditions: Schizophrenia
Schizoaffective Disorder

Interventions: Drug: haloperidol decanoate
Drug: paliperidone palmitate

Registration Number: NCT01136772

Lead Sponsor: New York State Psychiatric Institute

Brief 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).

Detailed Description: The purpose of this comparative effectiveness research study is to learn more about different medications called antipsychotics that are used to treat schizophrenia or schizoaffective disorder. Specifically, we are looking at long-acting medications that are given by injection every month, instead of being taken by mouth every day. In this multi-site study, we are comparing the risk and benefits of two FDA-approved long-acting injectable medications (paliperidone palmitate and haloperidol decanoate). Study participants with schizophrenia or schizoaffective disorder are expected to benefit from the improved medication schedule.

This study aims to enroll 360 individuals with schizophrenia or schizoaffective disorder for whom treatment with a long-acting injectable antipsychotic medication is likely to be helpful. Study participants will be randomly assigned to treatment with either paliperidone palmitate and haloperidol decanoate for up to 24 months. Participants will have an equal chance of being assigned to each medication, however participants will not know which medication they are taking.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 311

Inclusion Criteria

Diagnosis of schizophrenia or schizoaffective disorder as defined by DSM-IV-TR criteria
Age 18-65 years
Capacity to provide informed consent
Patients who are likely to benefit from treatment with long-acting injectable paliperidone palmitate or haloperidol decanoate
Women of child bearing potential must have a negative serum pregnancy test at the Screening Visit.

Exclusion Criteria

Patients who are currently stable and doing well on an antipsychotic regimen
Patients not expected to benefit from the study medications due to past experience with risperidone, paliperidone or haloperidol
Patients with tardive dyskinesia that is moderate or severe
Patients with any medical condition that, in the judgment of the investigator, might preclude safe completion of the study
Women who are pregnant or breastfeeding
Patients with mental retardation

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Haloperidol decanoate	haloperidol decanoate	Intramuscular injections of haloperidol decanoate 25-200 mg every month
Paliperidone palmitate	paliperidone palmitate	Intramuscular injections of paliperidone palmitate 39-234 mg every month

Primary Outcome Measures

Name	Time	Method
Efficacy Failure	24 months	Efficacy failure as indicated by psychiatric hospitalization, need for crisis intervention, clinical decision that oral antipsychotic medication cannot be discontinued in less than eight weeks, a clinical decision to discontinue the medication due to inadequate benefit, or the ongoing or repeated need for adjunctive antipsychotic medication.

Secondary Outcome Measures

Name	Time	Method
Changes in Psychiatric Symptoms	Baseline to 6 months	The Positive and Negative Syndrome Scale measures the core symptoms associated with schizophrenia. The measure includes 30 items rated from 1=absent to 7=extremely severe. Full range of scores is 30-210 with higher scores representing more severe illness. Reductions in symptoms over time represent improvement.

Trial Locations

Locations (22): VA Palo Alto Heathcare Systems
🇺🇸
Palo Alto, California, United States
Medical College of Georgia
🇺🇸
Augusta, Georgia, United States
John Umstead Hospital/Duke University
🇺🇸
Butner, North Carolina, United States
Louis Stokes Cleveland VA Medical Center
🇺🇸
Brecksville, Ohio, United States
VA Puget Sound Health Care System
🇺🇸
Tacoma, Washington, United States
Central Texas Veterans Health Care System
🇺🇸
Waco, Texas, United States
Frontier Institute
🇺🇸
Spokane, Washington, United States
Clinical Insights, Inc.
🇺🇸
Glen Burnie, Maryland, United States
Research Foundation for Mental Hygiene
🇺🇸
New York, New York, United States
University of Iowa Hospital
🇺🇸
Iowa City, Iowa, United States
Clinical Research Institute
🇺🇸
Wichita, Kansas, United States
University of Rochester
🇺🇸
Rochester, New York, United States
Yale University/Connecticut Mental Health Center
🇺🇸
New Haven, Connecticut, United States
University of Miami School of Medicine
🇺🇸
Miami, Florida, United States
John D. Dingell VA Medical Center
🇺🇸
Detroit, Michigan, United States
Sparrow St. Lawrence Hospital, Michigan State University Psychiatry
🇺🇸
Lansing, Michigan, United States
Kansas City Veterans Affairs Medical Center
🇺🇸
Kansas City, Missouri, United States
Creighton University Dept. of Psychiatry
🇺🇸
Omaha, Nebraska, United States
University of North Carolina
🇺🇸
Chapel Hill, North Carolina, United States
Carolina Behavioral Care
🇺🇸
Durham, North Carolina, United States
Philadelphia VA Medical Center-116A
🇺🇸
Philadelphia, Pennsylvania, United States
University of Texas Southwestern Medical Center
🇺🇸
Dallas, Texas, United States