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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01136772
Recruitment Status : Completed
First Posted : June 3, 2010
Results First Posted : April 24, 2015
Last Update Posted : October 21, 2016
National Institute of Mental Health (NIMH)
Duke University
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
New York State Psychiatric Institute

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.

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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

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

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.

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01136772

Show 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
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Principal Investigator: Scott Stroup, MD, MPH Columbia University
Principal Investigator: Joseph P McEvoy, MD Duke University
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: New York State Psychiatric Institute Identifier: NCT01136772    
Other Study ID Numbers: #6017
R01MH081107 ( U.S. NIH Grant/Contract )
First Posted: June 3, 2010    Key Record Dates
Results First Posted: April 24, 2015
Last Update Posted: October 21, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Paliperidone Palmitate
Haloperidol decanoate
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
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Anti-Dyskinesia Agents