Clinical trial NCT00423878: Comparison of Antipsychotics for Metabolic Problems in Schizophrenia or Schizoaffective Disorder
Official title: Clinical Management of Metabolic Problems in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Schizoaffective Disorder
Lead sponsor: National Institute of Mental Health (NIMH)
Sponsor class: NIH
First posted: 2007-01-18
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Metabolic abnormalities associated with cardiovascular morbidity and premature mortality are more common in patients with schizophrenia than in matched controls. Although there is some evidence that patients with schizophrenia have intrinsic abnormalities in lipid and carbohydrate metabolism, some antipsychotics (i.e., clozapine, olanzapine, quetiapine, and risperidone) are associated with increased rates of metabolic abnormalities that predispose patients to cardiovascular disease.

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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Non-HDL Cholesterol Level for Patients Assigned to Stay and Patients Assigned to Switch Over 24 Weeks
timeFrame: 24 weeks
Secondary outcomes:
measure: Efficacy Failure, Defined as Psychiatric Hospitalization, a 25 Percent Increase From Baseline on the Positive and Negative Syndrome Scale or Substantial Clinical Deterioration on the Clinical Global Impressions-Change (CGI-C)
timeFrame: Measured at Month 6
Other outcomes:
Locations:
city: Colton
country: United States
facility: SHANTI Clinical Trials
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Boca Raton
country: United States
facility: Mental Health Advocates
state: Florida
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Augusta
country: United States
facility: Medical College of Georgia
state: Georgia
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Wichita
country: United States
facility: Clinical Research Institute
state: Kansas
city: Shreveport
country: United States
facility: Lousiana State University Health Sciences Center
state: Louisiana
city: Glen Burnie
country: United States
facility: Clinical Insights
state: Maryland
city: Boston
country: United States
facility: Freedom Trail Clinic
state: Massachusetts
city: Fall River
country: United States
facility: John C Corrigan Community Mental Health Center
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Albuquerque
country: United States
facility: New Mexico VA Healthcare System
state: New Mexico
city: New York
country: United States
facility: Research Foundation for Mental Hygiene
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Butner
country: United States
facility: John Umstead Hospital/Duke University
state: North Carolina
city: Chapel Hill
country: United States
facility: The University of North Carolina
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas HealthCare System
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Philadelphia
country: United States
facility: Philadelphia VA Medical Center-116A
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: Columbia University
name: T. Scott Stroup, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Joseph P. McEvoy, MD
role: STUDY_DIRECTOR
References:
citation: 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.