A Comparison of Long-acting Injectable Medications for Schizophrenia
NCT ID: NCT01136772
Last Updated: 2016-10-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
311 participants
INTERVENTIONAL
2011-03-31
2016-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Paliperidone palmitate
Intramuscular injections of paliperidone palmitate 39-234 mg every month
paliperidone palmitate
Paliperidone palmitate injections, 39 mg - 234 mg once a month
Haloperidol decanoate
Intramuscular injections of haloperidol decanoate 25-200 mg every month
haloperidol decanoate
haloperidol decanoate injections, 25-200 mg once a month
Interventions
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haloperidol decanoate
haloperidol decanoate injections, 25-200 mg once a month
paliperidone palmitate
Paliperidone palmitate injections, 39 mg - 234 mg once a month
Other Intervention Names
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Eligibility Criteria
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Inclusion 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 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
18 Years
65 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Duke University
OTHER
University of North Carolina, Chapel Hill
OTHER
New York State Psychiatric Institute
OTHER
Responsible Party
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Principal Investigators
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Scott Stroup, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Joseph P McEvoy, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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VA Palo Alto Heathcare Systems
Palo Alto, California, United States
Yale University/Connecticut Mental Health Center
New Haven, Connecticut, United States
University of Miami School of Medicine
Miami, Florida, United States
Medical College of Georgia
Augusta, Georgia, United States
University of Iowa Hospital
Iowa City, Iowa, United States
Clinical Research Institute
Wichita, Kansas, United States
Clinical Insights, Inc.
Glen Burnie, Maryland, 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
Research Foundation for Mental Hygiene
New York, New York, United States
University of Rochester
Rochester, New York, United States
John Umstead Hospital/Duke University
Butner, North Carolina, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Carolina Behavioral Care
Durham, North Carolina, United States
Louis Stokes Cleveland VA Medical Center
Brecksville, Ohio, United States
Philadelphia VA Medical Center-116A
Philadelphia, Pennsylvania, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Central Texas Veterans Health Care System
Waco, Texas, United States
Frontier Institute
Spokane, Washington, United States
VA Puget Sound Health Care System
Tacoma, Washington, United States
Countries
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References
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McEvoy JP, Byerly M, Hamer RM, Dominik R, Swartz MS, Rosenheck RA, Ray N, Lamberti JS, Buckley PF, Wilkins TM, Stroup TS. Effectiveness of paliperidone palmitate vs haloperidol decanoate for maintenance treatment of schizophrenia: a randomized clinical trial. JAMA. 2014 May 21;311(19):1978-87. doi: 10.1001/jama.2014.4310.
Rosenheck RA, Leslie DL, Sint KJ, Lin H, Li Y, McEvoy JP, Byerly MJ, Hamer RM, Swartz MS, Stroup TS. Cost-Effectiveness of Long-Acting Injectable Paliperidone Palmitate Versus Haloperidol Decanoate in Maintenance Treatment of Schizophrenia. Psychiatr Serv. 2016 Oct 1;67(10):1124-1130. doi: 10.1176/appi.ps.201500447. Epub 2016 Jun 1.
Stroup TS, Bareis NA, Rosenheck RA, Swartz MS, McEvoy JP. Heterogeneity of Treatment Effects of Long-Acting Injectable Antipsychotic Medications. J Clin Psychiatry. 2018 Nov 27;80(1):18m12109. doi: 10.4088/JCP.18m12109.
Other Identifiers
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#6017
Identifier Type: -
Identifier Source: org_study_id
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