Comparison of Antipsychotics for Metabolic Problems in Schizophrenia or Schizoaffective Disorder

Completed · Phase 4

Conditions studied: Schizophrenia, Schizoaffective Disorder

In brief

The study will compare the effectiveness of antipsychotic medications for patients with schizophrenia or schizoaffective disorder for whom a medication change may be indicated because of an increased risk of cardiovascular disease.

Key facts

Study ID

NCT00423878

Run by

National Institute of Mental Health (NIMH)

People needed

215

Starts

2007-01-01

Expected to finish

2010-03-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with schizophrenia or schizoaffective disorder
• 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).

You may not qualify if…

• Diabetes (FBS greater than or equal to 126) or treatment with oral hypoglycemic drug or insulin
• 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

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

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