Comparison of Antipsychotics for Metabolic Problems in Schizophrenia or Schizoaffective Disorder

Schizophrenia Clinical Trial

— CAMP  

Official title:

Clinical Management of Metabolic Problems in Patients With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00423878
• Other study ID #: STROUP06STN0
• Secondary ID: DSIR AT-AP
• Status: Completed
• Phase: Phase 4
• First received: January 16, 2007
• Last updated: December 7, 2015
• Start date: January 2007
• Est. completion date: March 2010

Study information

• Verified date: November 2010
• Source: National Institute of Mental Health (NIMH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: March 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	New Mexico VA Healthcare System	Albuquerque	New Mexico
United States	Emory University	Atlanta	Georgia
United States	Medical College of Georgia	Augusta	Georgia
United States	Mental Health Advocates	Boca Raton	Florida
United States	Freedom Trail Clinic	Boston	Massachusetts
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	SHANTI Clinical Trials	Colton	California
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Wayne State University	Detroit	Michigan
United States	John C Corrigan Community Mental Health Center	Fall River	Massachusetts
United States	Clinical Insights	Glen Burnie	Maryland
United States	Baylor College of Medicine	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	University of Miami School of Medicine	Miami	Florida
United States	University of Minnesota	Minneapolis	Minnesota
United States	Yale University	New Haven	Connecticut
United States	Research Foundation for Mental Hygiene	New York	New York
United States	Stanford University	Palo Alto	California
United States	Philadelphia VA Medical Center-116A	Philadelphia	Pennsylvania
United States	University of Rochester	Rochester	New York
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Lousiana State University Health Sciences Center	Shreveport	Louisiana
United States	Washington University School of Medicine	St. Louis	Missouri
United States	Clinical Research Institute	Wichita	Kansas
United States	University of Massachusetts	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Difference in Non-HDL Cholesterol Level Changes Between Patients Assigned to Stay Compared to Patients Assigned to Switch at the Last Observation		Measured at Month 6	No
Secondary	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)		Measured at Month 6	Yes