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A Comparison of Long-acting Injectable Medications for Schizophrenia (ACLAIMS)
This study has been completed.
Sponsor:
New York State Psychiatric Institute
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: September 6, 2016
Last verified: July 2016
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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 Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, 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 ]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 ]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 |
| 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) |
| 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
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
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:
| 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 ) |
| Study First Received: | May 14, 2010 |
| Results First Received: | March 25, 2015 |
| Last Updated: | September 6, 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 |
ClinicalTrials.gov processed this record on September 21, 2017