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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
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 23, 2013
Last verified: September 2013
  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:


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

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 360
Study Start Date: February 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paliperidone palmitate Drug: paliperidone palmitate
Paliperidone palmitate injections, 39 mg - 234 mg once a month
Other Name: Invega Sustenna
Active Comparator: Haloperidol decanoate 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
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
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

No publications provided by New York State Psychiatric Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Last Updated: September 23, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
9-hydroxy-risperidone
Haloperidol
Haloperidol decanoate
Anti-Dyskinesia Agents
Antiemetics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 23, 2014