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

This study is ongoing, but not recruiting participants.
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: September 6, 2012
Last verified: September 2012
History of Changes

May 14, 2010
September 6, 2012
February 2011
December 2013   (final data collection date for primary outcome measure)
Inadequate therapeutic benefit [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Inadequate therapeutic benefit will reflect 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.
Inadequate therapeutic benefit [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Inadequate therapeutic benefit will reflect efficacy failure.
Complete list of historical versions of study NCT01136772 on ClinicalTrials.gov Archive Site
Measures of clinical status [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Positive and Negative Syndrome Scale (PANSS) Clinical Global Impressions-Severity Scale (CGI-S) Alcohol Use Scale and Drug Use Scale (AUS/DUS)
Same as current
Not Provided
Not Provided
 
A Comparison of Long-acting Injectable Medications for Schizophrenia
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).

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Schizophrenia
  • Schizoaffective Disorder
  • Drug: haloperidol decanoate
    haloperidol decanoate injections, 25-200 mg once a month
    Other Name: Haldol
  • Drug: paliperidone palmitate
    Paliperidone palmitate injections, 39 mg - 234 mg once a month
    Other Name: Invega Sustenna
  • Experimental: Paliperidone palmitate
    Intervention: Drug: paliperidone palmitate
  • Active Comparator: Haloperidol decanoate
    Intervention: Drug: haloperidol decanoate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
360
May 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01136772
#6017, R01MH081107
Yes
New York State Psychiatric Institute
New York State Psychiatric Institute
  • National Institute of Mental Health (NIMH)
  • Duke University
  • University of North Carolina, Chapel Hill
Principal Investigator: Scott Stroup, MD, MPH Columbia University
Principal Investigator: Joseph P McEvoy, MD Duke University
New York State Psychiatric Institute
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP