Comparison of Antipsychotics for Metabolic Problems in Schizophrenia or Schizoaffective Disorder
NCT ID: NCT00423878
Last Updated: 2016-11-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
215 participants
INTERVENTIONAL
2007-01-31
2010-03-31
Brief Summary
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Detailed Description
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This is an investigator-initiated clinical trial that will be conducted at 30 research sites that are a part of the NIMH Schizophrenia Trials Network.
The aims of the study are to (1) determine the relative effects of switching to aripiprazole, versus continued treatment with olanzapine, quetiapine, or risperidone, on metabolic parameters associated with cardiovascular disease, and (2) to determine the effects of switching to aripiprazole versus continued treatment with olanzapine, quetiapine, or risperidone on the clinical stability of schizophrenic illness.
This study design is a multi-site, single-blind (rater) randomized controlled trial of 300 patients with schizophrenia or schizoaffective disorder comparing treatment with the following medications: olanzapine, quetiapine, risperidone, and aripiprazole. The study will enroll patients with schizophrenia or schizoaffective disorder for whom a medication change may be indicated because of an increased risk of cardiovascular disease in spite of adequate control of symptoms on their current antipsychotic medication. Patients who are taking olanzapine, quetiapine, or risperidone and who have a body-mass index (BMI) greater than or equal to 27 and non-HDL cholesterol greater than or equal to 130 mg/dl will be eligible (if non-HDL is between 130-139mg/dL, LDL cholesterol must be greater than 100mg/dL). All treatments will be open label. Raters will be blinded to treatment assignment. Patients will be followed for up to 6 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
Participants will switch to aripiprazole with a cross-titration from the current antipsychotic over 3-4 weeks. Allowed final dosage range for aripiprazole was 5-30 mg/day
Aripiprazole
Switching medication to aripiprazole for schizophrenia for up to 6 months in study
2
Participants will continue with their current antipsychotic treatment, either olanzapine 5-20 mg/day, quetiapine 200-1200 mg/day, or risperidone 1-16 mg/day.
Risperidone
Continued treatment with the medication risperidone for schizophrenia for up to 6 months in study
Olanzapine
Continued treatment with the medication olanzapine for schizophrenia for up to 6 months in study
Quetiapine
Continued treatment with the medication quetiapine for schizophrenia for up to 6 months in study
Interventions
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Risperidone
Continued treatment with the medication risperidone for schizophrenia for up to 6 months in study
Olanzapine
Continued treatment with the medication olanzapine for schizophrenia for up to 6 months in study
Quetiapine
Continued treatment with the medication quetiapine for schizophrenia for up to 6 months in study
Aripiprazole
Switching medication to aripiprazole for schizophrenia for up to 6 months in study
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Currently treated with olanzapine, quetiapine or risperidone
* BMI greater than or equal to 27
* Non-HDL cholesterol greater than or equal to 130 mg/dL (if non-HDL cholesterol is between 130 - 139 mg/dL, then LDL cholesterol must be greater than 100 mg/dL).
Exclusion Criteria
* Non-HDL cholesterol greater than 300 mg/dL
* Serum triglycerides greater than 500 mg/dL
* Patients in the first episode of schizophrenia or schizoaffective disorder
* Known hypersensitivity to aripiprazole
* On weight loss medications
18 Years
65 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Responsible Party
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Principal Investigators
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T. Scott Stroup, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Joseph P. McEvoy, MD
Role: STUDY_DIRECTOR
Duke University
Locations
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SHANTI Clinical Trials
Colton, California, United States
Stanford University
Palo Alto, California, United States
Yale University
New Haven, Connecticut, United States
Mental Health Advocates
Boca Raton, Florida, United States
University of Miami School of Medicine
Miami, Florida, United States
Emory University
Atlanta, Georgia, United States
Medical College of Georgia
Augusta, Georgia, United States
University of Iowa
Iowa City, Iowa, United States
Clinical Research Institute
Wichita, Kansas, United States
Lousiana State University Health Sciences Center
Shreveport, Louisiana, United States
Clinical Insights
Glen Burnie, Maryland, United States
Freedom Trail Clinic
Boston, Massachusetts, United States
John C Corrigan Community Mental Health Center
Fall River, Massachusetts, United States
University of Massachusetts
Worcester, Massachusetts, United States
Wayne State University
Detroit, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
New Mexico VA Healthcare System
Albuquerque, New Mexico, United States
Research Foundation for Mental Hygiene
New York, New York, United States
University of Rochester
Rochester, New York, United States
John Umstead Hospital/Duke University
Butner, North Carolina, United States
The University of North Carolina
Chapel Hill, North Carolina, United States
Carolinas HealthCare System
Charlotte, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Philadelphia VA Medical Center-116A
Philadelphia, Pennsylvania, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Countries
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References
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Stroup TS, McEvoy JP, Ring KD, Hamer RH, LaVange LM, Swartz MS, Rosenheck RA, Perkins DO, Nussbaum AM, Lieberman JA; Schizophrenia Trials Network. A randomized trial examining the effectiveness of switching from olanzapine, quetiapine, or risperidone to aripiprazole to reduce metabolic risk: comparison of antipsychotics for metabolic problems (CAMP). Am J Psychiatry. 2011 Sep;168(9):947-56. doi: 10.1176/appi.ajp.2011.10111609. Epub 2011 Jul 18.
Other Identifiers
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DSIR AT-AP
Identifier Type: OTHER
Identifier Source: secondary_id
STROUP06STN0
Identifier Type: -
Identifier Source: org_study_id