A Comparison of Long-acting Injectable Medications for Schizophrenia
ACLAIMS
A Comparison of Long-Acting Injectable Medications for Schizophrenia
2 other identifiers
interventional
311
1 country
22
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 schizophrenia
Started Mar 2011
Longer than P75 for phase_4 schizophrenia
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2010
CompletedFirst Posted
Study publicly available on registry
June 3, 2010
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedResults Posted
Study results publicly available
April 24, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedOctober 21, 2016
July 1, 2016
2.3 years
May 14, 2010
March 25, 2015
September 6, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Efficacy Failure
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.
24 months
Secondary Outcomes (1)
Changes in Psychiatric Symptoms
Baseline to 6 months
Study Arms (2)
Paliperidone palmitate
EXPERIMENTALIntramuscular injections of paliperidone palmitate 39-234 mg every month
Haloperidol decanoate
ACTIVE COMPARATORIntramuscular injections of haloperidol decanoate 25-200 mg every month
Interventions
haloperidol decanoate injections, 25-200 mg once a month
Paliperidone palmitate injections, 39 mg - 234 mg once a month
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- New York State Psychiatric Institutelead
- National Institute of Mental Health (NIMH)collaborator
- Duke Universitycollaborator
- University of North Carolina, Chapel Hillcollaborator
Study Sites (22)
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
Related Publications (3)
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.
PMID: 24846035RESULTRosenheck 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.
PMID: 27247177RESULTStroup 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.
PMID: 30549494DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- T. Scott Stroup
- Organization
- Columbia University
Study Officials
- PRINCIPAL INVESTIGATOR
Scott Stroup, MD, MPH
Columbia University
- PRINCIPAL INVESTIGATOR
Joseph P McEvoy, MD
Duke University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2010
First Posted
June 3, 2010
Study Start
March 1, 2011
Primary Completion
July 1, 2013
Study Completion
July 1, 2016
Last Updated
October 21, 2016
Results First Posted
April 24, 2015
Record last verified: 2016-07