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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2013 by New York State Psychiatric Institute.
Recruitment status was Active, not recruiting

Sponsor:

Collaborators:

National Institute of Mental Health (NIMH)

Duke University

University of North Carolina, Chapel Hill

Information provided by (Responsible Party):

New York State Psychiatric Institute

ClinicalTrials.gov Identifier:

NCT01136772

First received: May 14, 2010

Last updated: April 7, 2015

Last verified: September 2013

History of Changes

Purpose

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	Intervention	Phase
Schizophrenia Schizoaffective Disorder	Drug: haloperidol decanoate Drug: paliperidone palmitate	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	A Comparison of Long-Acting Injectable Medications for Schizophrenia

Resource links provided by NLM:

Genetics Home Reference related topics: schizophrenia

MedlinePlus related topics: Schizophrenia

Drug Information available for: Haloperidol Haloperidol decanoate Paliperidone Paliperidone Palmitate

U.S. FDA Resources

Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:

Efficacy Failure [ Time Frame: 24 months ] [ Designated as safety issue: No ]
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:

Changes in Psychiatric Symptoms [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
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.


Enrollment:	311
Study Start Date:	March 2011
Estimated Study Completion Date:	July 2016
Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01136772

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

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.


Responsible Party:	New York State Psychiatric Institute
ClinicalTrials.gov Identifier:	NCT01136772 History of Changes
Other Study ID Numbers:	#6017 R01MH081107
Study First Received:	May 14, 2010
Results First Received:	March 25, 2015
Last Updated:	April 7, 2015
Health Authority:	United States: Federal Government

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

ClinicalTrials.gov processed this record on September 30, 2016

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