Clinical trial NCT01136772: A Comparison of Long-acting Injectable Medications for Schizophrenia
Official title: A Comparison of Long-Acting Injectable Medications for Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Schizoaffective Disorder
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Duke University
name: University of North Carolina, Chapel Hill
First posted: 2010-06-03
Enrollment: 311
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Efficacy Failure
timeFrame: 24 months
Secondary outcomes:
measure: Changes in Psychiatric Symptoms
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Heathcare Systems
state: California
city: New Haven
country: United States
facility: Yale University/Connecticut Mental Health Center
state: Connecticut
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
city: Augusta
country: United States
facility: Medical College of Georgia
state: Georgia
city: Iowa City
country: United States
facility: University of Iowa Hospital
state: Iowa
city: Wichita
country: United States
facility: Clinical Research Institute
state: Kansas
city: Glen Burnie
country: United States
facility: Clinical Insights, Inc.
state: Maryland
city: Detroit
country: United States
facility: John D. Dingell VA Medical Center
state: Michigan
city: Lansing
country: United States
facility: Sparrow St. Lawrence Hospital, Michigan State University Psychiatry
state: Michigan
city: Kansas City
country: United States
facility: Kansas City Veterans Affairs Medical Center
state: Missouri
city: Omaha
country: United States
facility: Creighton University Dept. of Psychiatry
state: Nebraska
city: New York
country: United States
facility: Research Foundation for Mental Hygiene
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Butner
country: United States
facility: John Umstead Hospital/Duke University
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Durham
country: United States
facility: Carolina Behavioral Care
state: North Carolina
city: Brecksville
country: United States
facility: Louis Stokes Cleveland VA Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Philadelphia VA Medical Center-116A
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Waco
country: United States
facility: Central Texas Veterans Health Care System
state: Texas
city: Spokane
country: United States
facility: Frontier Institute
state: Washington
city: Tacoma
country: United States
facility: VA Puget Sound Health Care System
state: Washington
Study officials:
affiliation: Columbia University
name: Scott Stroup, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Joseph P McEvoy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.