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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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).

Condition or disease	Intervention/treatment	Phase
Schizophrenia; Schizoaffective Disorder	Drug: haloperidol decanoate; Drug: paliperidone palmitate	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	311 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	A Comparison of Long-Acting Injectable Medications for Schizophrenia
Study Start Date :	March 2011
Actual Primary Completion Date :	July 2013
Actual Study Completion Date :	July 2016

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: 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 Name: Haldol

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Efficacy Failure [ Time Frame: 24 months ]
   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.

Secondary Outcome Measures :

1. Changes in Psychiatric Symptoms [ Time Frame: Baseline to 6 months ]
   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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 22 Study Locations

Sponsors and Collaborators

New York State Psychiatric Institute

National Institute of Mental Health (NIMH)

Duke University

University of North Carolina, Chapel Hill

Investigators

Principal Investigator:	Scott Stroup, MD, MPH	Columbia University
Principal Investigator:	Joseph P McEvoy, MD	Duke University

More Information

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Publications of Results:

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. Epub 2016 Jun 1.

Responsible Party:	New York State Psychiatric Institute
ClinicalTrials.gov Identifier:	NCT01136772 History of Changes
Other Study ID Numbers:	#6017; R01MH081107 ( U.S. NIH Grant/Contract )
First Posted:	June 3, 2010
Results First Posted:	April 24, 2015
Last Update Posted:	October 21, 2016
Last Verified:	July 2016

Additional relevant MeSH terms:

Schizophrenia; Psychotic Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Paliperidone Palmitate; Haloperidol; Haloperidol decanoate; Decanoic acid; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Psychotropic Drugs; Serotonin 5-HT2 Receptor Antagonists	Serotonin Antagonists; Serotonin Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Dopamine Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Anti-Dyskinesia Agents; Antifungal Agents; Anti-Infective Agents