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Completed

NCT Number: NCT01136772

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).

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Key information

Conditions

Schizophrenia Mental Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

VA Palo Alto Heathcare Systems, Palo Alto, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Haloperidol Decanoate

Drug

haloperidol decanoate injections, 25-200 mg once a month

Other names: Haldol

Paliperidone palmitate

Drug

Paliperidone palmitate injections, 39 mg - 234 mg once a month

Other names: Invega Sustenna

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • Duke University
  • National Institute of Mental Health (NIMH)
  • University of North Carolina, Chapel Hill

Registry information

Acronym: ACLAIMS

Important dates

Study start
2011
Primary completion
2013
Study completion
2016
First posted
Jun 3, 2010
Registry last updated
Oct 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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