A Comparison of Long-acting Injectable Medications for Schizophrenia

Schizophrenia Clinical Trial

— ACLAIMS  

Official title:

A Comparison of Long-Acting Injectable Medications for Schizophrenia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01136772
• Other study ID #: #6017
• Secondary ID: R01MH081107
• Status: Active, not recruiting
• Phase: Phase 4
• First received: May 14, 2010
• Last updated: April 7, 2015
• Start date: March 2011
• Est. completion date: July 2016

Study information

• Verified date: September 2013
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 311
• Est. completion date: July 2016
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• haloperidol decanoate
haloperidol decanoate injections, 25-200 mg once a month
• paliperidone palmitate
Paliperidone palmitate injections, 39 mg - 234 mg once a month

Locations

Country	Name	City	State
United States	Medical College of Georgia	Augusta	Georgia
United States	Louis Stokes Cleveland VA Medical Center	Brecksville	Ohio
United States	John Umstead Hospital/Duke University	Butner	North Carolina
United States	University of North Carolina	Chapel Hill	North Carolina
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	John D. Dingell VA Medical Center	Detroit	Michigan
United States	Carolina Behavioral Care	Durham	North Carolina
United States	Clinical Insights, Inc.	Glen Burnie	Maryland
United States	University of Iowa Hospital	Iowa City	Iowa
United States	Kansas City Veterans Affairs Medical Center	Kansas City	Missouri
United States	Sparrow St. Lawrence Hospital, Michigan State University Psychiatry	Lansing	Michigan
United States	University of Miami School of Medicine	Miami	Florida
United States	Yale University/Connecticut Mental Health Center	New Haven	Connecticut
United States	Research Foundation for Mental Hygiene	New York	New York
United States	Creighton University Dept. of Psychiatry	Omaha	Nebraska
United States	VA Palo Alto Heathcare Systems	Palo Alto	California
United States	Philadelphia VA Medical Center-116A	Philadelphia	Pennsylvania
United States	University of Rochester	Rochester	New York
United States	Frontier Institute	Spokane	Washington
United States	VA Puget Sound Health Care System	Tacoma	Washington
United States	Central Texas Veterans Health Care System	Waco	Texas
United States	Clinical Research Institute	Wichita	Kansas

Sponsors (4)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	Duke University, National Institute of Mental Health (NIMH), University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 tr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 months	No
Secondary	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.	Baseline to 6 months	No