A Comparison of Long-acting Injectable Medications for Schizophrenia (ACLAIMS)

A Comparison of Long-Acting Injectable Medications for Schizophrenia

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).

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Schizoaffective Disorder
• Intervention / Treatment: Drug: paliperidone palmitate; Drug: haloperidol decanoate

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.

• Study Type: Interventional
• Enrollment (Actual): 311
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • VA Palo Alto Heathcare Systems
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale University/Connecticut Mental Health Center
  • Florida
    • Miami, Florida, United States, 33316
      • University of Miami School of Medicine
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Medical College of Georgia
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospital
  • Kansas
    • Wichita, Kansas, United States, 67207
      • Clinical Research Institute
  • Maryland
    • Glen Burnie, Maryland, United States, 21061
      • Clinical Insights, Inc.
  • Michigan
    • Detroit, Michigan, United States, 48201
      • John D. Dingell VA Medical Center
    • Lansing, Michigan, United States, 48915
      • Sparrow St. Lawrence Hospital, Michigan State University Psychiatry
  • Missouri
    • Kansas City, Missouri, United States, 64128
      • Kansas City Veterans Affairs Medical Center
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • Creighton University Dept. of Psychiatry
  • New York
    • New York, New York, United States, 10032
      • Research Foundation for Mental Hygiene
    • Rochester, New York, United States, 14623
      • University of Rochester
  • North Carolina
    • Butner, North Carolina, United States, 27509
      • John Umstead Hospital/Duke University
    • Chapel Hill, North Carolina, United States, 27599-7160
      • University of North Carolina
    • Durham, North Carolina, United States, 27705
      • Carolina Behavioral Care
  • Ohio
    • Brecksville, Ohio, United States, 44141
      • Louis Stokes Cleveland VA Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia VA Medical Center-116A
  • Texas
    • Dallas, Texas, United States, 75235
      • University of Texas Southwestern Medical Center
    • Waco, Texas, United States, 78711
      • Central Texas Veterans Health Care System
  • Washington
    • Spokane, Washington, United States, 99204
      • Frontier Institute
    • Tacoma, Washington, United States, 98493
      • VA Puget Sound Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Paliperidone palmitate; Intramuscular injections of paliperidone palmitate 39-234 mg every month	Drug: paliperidone palmitate; Paliperidone palmitate injections, 39 mg - 234 mg once a month; Other Names: Invega Sustenna
ACTIVE_COMPARATOR: Haloperidol decanoate; Intramuscular injections of haloperidol decanoate 25-200 mg every month	Drug: haloperidol decanoate; haloperidol decanoate injections, 25-200 mg once a month; Other Names: Haldol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Psychiatric Symptoms	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.	Baseline to 6 months

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute
• Collaborators: National Institute of Mental Health (NIMH); Duke University; University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Scott Stroup, MD, MPH, Columbia University

Publications and helpful links

General Publications

• 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. Erratum In: JAMA. 2014 Oct 8;312(14):1473.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (ACTUAL): July 1, 2013
• Study Completion (ACTUAL): July 1, 2016

Study Registration Dates

• First Submitted: May 14, 2010
• First Submitted That Met QC Criteria: June 2, 2010
• First Posted (ESTIMATE): June 3, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): October 21, 2016
• Last Update Submitted That Met QC Criteria: September 6, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Anti-Dyskinesia Agents; Paliperidone Palmitate; Haloperidol; Haloperidol decanoate
• Other Study ID Numbers: #6017; R01MH081107 (NIH)