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A Comparison of Long-acting Injectable Medications for Schizophrenia

Information source: New York State Psychiatric Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia; Schizoaffective Disorder

Intervention: haloperidol decanoate (Drug); paliperidone palmitate (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: New York State Psychiatric Institute

Official(s) and/or principal investigator(s):
Scott Stroup, MD, MPH, Principal Investigator, Affiliation: Columbia University
Joseph P McEvoy, MD, Principal Investigator, Affiliation: Duke University

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).

Clinical Details

Official title: A Comparison of Long-Acting Injectable Medications for Schizophrenia

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Efficacy Failure

Secondary outcome: Changes in Psychiatric Symptoms

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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

VA Palo Alto Heathcare Systems, Palo Alto, California 94304, United States

Yale University/Connecticut Mental Health Center, New Haven, Connecticut 06519, United States

University of Miami School of Medicine, Miami, Florida 33316, United States

Medical College of Georgia, Augusta, Georgia 30912, United States

University of Iowa Hospital, Iowa City, Iowa 52242, United States

Clinical Research Institute, Wichita, Kansas 67207, United States

Clinical Insights, Inc., Glen Burnie, Maryland 21061, United States

John D. Dingell VA Medical Center, Detroit, Michigan 48201, United States

Sparrow St. Lawrence Hospital, Michigan State University Psychiatry, Lansing, Michigan 48915, United States

Kansas City Veterans Affairs Medical Center, Kansas City, Missouri 64128, United States

Creighton University Dept. of Psychiatry, Omaha, Nebraska 68131, United States

Research Foundation for Mental Hygiene, New York, New York 10032, United States

University of Rochester, Rochester, New York 14623, United States

John Umstead Hospital/Duke University, Butner, North Carolina 27509, United States

University of North Carolina, Chapel Hill, North Carolina 27599-7160, United States

Carolina Behavioral Care, Durham, North Carolina 27705, United States

Louis Stokes Cleveland VA Medical Center, Brecksville, Ohio 44141, United States

Philadelphia VA Medical Center-116A, Philadelphia, Pennsylvania 19104, United States

University of Texas Southwestern Medical Center, Dallas, Texas 75235, United States

Central Texas Veterans Health Care System, Waco, Texas 78711, United States

Frontier Institute, Spokane, Washington 99204, United States

VA Puget Sound Health Care System, Tacoma, Washington 98493, United States

Additional Information

Starting date: March 2011
Last updated: April 7, 2015

Page last updated: August 23, 2015

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