SchizophreniaPhase 4ACLAIMSNCT01136772
A Comparison of Long-acting Injectable Medications for Schizophrenia
A Phase 4 study testing haloperidol decanoate and paliperidone palmitate in people with Schizophrenia and Schizoaffective Disorder, run by New York State Psychiatric Institute at 22 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- haloperidol decanoate and paliperidone palmitate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 311 participants
- Where
- 22 sitesUnited States
- Study dates
- Mar 2011to Jul 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Medical College of Georgia
Augusta, Georgia, 30912
Louis Stokes Cleveland VA Medical Center
Brecksville, Ohio, 44141
John Umstead Hospital/Duke University
Butner, North Carolina, 27509
University of North Carolina
Chapel Hill, North Carolina, 27599-7160
University of Texas Southwestern Medical Center
Dallas, Texas, 75235
John D. Dingell VA Medical Center
Detroit, Michigan, 48201
Carolina Behavioral Care
Durham, North Carolina, 27705
Clinical Insights, Inc.
Glen Burnie, Maryland, 21061
University of Iowa Hospital
Iowa City, Iowa, 52242
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, 64128
Sparrow St. Lawrence Hospital, Michigan State University Psychiatry
Lansing, Michigan, 48915
University of Miami School of Medicine
Miami, Florida, 33316
Yale University/Connecticut Mental Health Center
New Haven, Connecticut, 06519
Research Foundation for Mental Hygiene
New York, New York, 10032
Creighton University Dept. of Psychiatry
Omaha, Nebraska, 68131
VA Palo Alto Heathcare Systems
Palo Alto, California, 94304
Philadelphia VA Medical Center-116A
Philadelphia, Pennsylvania, 19104
University of Rochester
Rochester, New York, 14623
Frontier Institute
Spokane, Washington, 99204
VA Puget Sound Health Care System
Tacoma, Washington, 98493
Central Texas Veterans Health Care System
Waco, Texas, 78711
Clinical Research Institute
Wichita, Kansas, 67207
About this study
Official title: 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).
Read the 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.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- haloperidol decanoate, paliperidone palmitate
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
haloperidol decanoateDrug
Also called Haldol
haloperidol decanoate injections, 25-200 mg once a month
paliperidone palmitateDrug
Also called Invega Sustenna
Paliperidone palmitate injections, 39 mg - 234 mg once a month
| Study group | Role | What they receive |
|---|---|---|
| Paliperidone palmitate | Experimental | Intramuscular injections of paliperidone palmitate 39-234 mg every month Receives: Drug: paliperidone palmitate |
| Haloperidol decanoate | Active comparator | Intramuscular injections of haloperidol decanoate 25-200 mg every month Receives: Drug: haloperidol decanoate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (1)
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.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startMar 2011
- Primary completionJul 2013
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Duke University, University of North Carolina, Chapel Hill
- Responsible party
- Sponsor
- Investigators
- Scott Stroup, MD, MPH, Principal investigator, Columbia UniversityJoseph P McEvoy, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01136772
- Sponsor's protocol ID
- #6017
- Other IDs
- R01MH081107
- Acronym
- ACLAIMS
- Status last verified
- Jul 2016
- First submitted
- 14 May 2010
- Last updated
- 21 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 24846035Rosenheck 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.
PubMed 27247177Stroup 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.
PubMed 30549494
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Long-Acting Injectable Medications for Schizophrenia
- ClinicalTrials.gov ID
- NCT01136772
- Acronym / sponsor ID
- ACLAIMS / #6017
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Duke University, University of North Carolina, Chapel Hill
- Study start
- Mar 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 3 Jun 2010 (estimated)
- Results
- Posted 24 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paliperidone palmitate | Experimental | Drug: paliperidone palmitateIntramuscular injections of paliperidone palmitate 39-234 mg every month |
| Haloperidol decanoate | Active comparator | Drug: haloperidol decanoateIntramuscular injections of haloperidol decanoate 25-200 mg every month |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| haloperidol decanoateAlso: Haldolhaloperidol decanoate injections, 25-200 mg once a month | Drug | Haloperidol decanoate |
| paliperidone palmitateAlso: Invega SustennaPaliperidone palmitate injections, 39 mg - 234 mg once a month | Drug | Paliperidone palmitate |
Primary outcome
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.
1 secondary outcome
Changes in Psychiatric Symptoms
Time frame: Baseline to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24846035McEvoy 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.
- Results publication: PubMed 27247177Rosenheck 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.
- Derived from this study: PubMed 30549494Stroup 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.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Stroup, MD, MPH principal investigator
Columbia University
Joseph P McEvoy, MD principal investigator
Duke University
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing haloperidol decanoate and paliperidone palmitate in people with Schizophrenia and Schizoaffective Disorder, run by New York State Psychiatric Institute at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy Failure (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01136772, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2016.