Comparison of Antipsychotics for Metabolic Problems in Schizophrenia or Schizoaffective Disorder
CAMP
Clinical Management of Metabolic Problems in Patients With Schizophrenia
2 other identifiers
interventional
215
1 country
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 schizophrenia
Started Jan 2007
Typical duration for phase_4 schizophrenia
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 16, 2007
CompletedFirst Posted
Study publicly available on registry
January 18, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedResults Posted
Study results publicly available
December 19, 2012
CompletedNovember 2, 2016
November 1, 2010
2.8 years
January 16, 2007
November 16, 2012
September 27, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Non-HDL Cholesterol Level for Patients Assigned to Stay and Patients Assigned to Switch Over 24 Weeks
Change in non-HDL cholesterol measured at baseline and every 4 weeks for 24 weeks. The efficacy analysis corresponded to a comparison of change in non-HDL cholesterol from baseline to 24 weeks between treatment groups (stay versus switch). Repeated measurements mixed effects linear models were fit for the primary analysis.
24 weeks
Secondary Outcomes (1)
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
Study Arms (2)
1
EXPERIMENTALParticipants 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
2
ACTIVE COMPARATORParticipants will continue with their current antipsychotic treatment, either olanzapine 5-20 mg/day, quetiapine 200-1200 mg/day, or risperidone 1-16 mg/day.
Interventions
Continued treatment with the medication risperidone for schizophrenia for up to 6 months in study
Continued treatment with the medication olanzapine for schizophrenia for up to 6 months in study
Continued treatment with the medication quetiapine for schizophrenia for up to 6 months in study
Switching medication to aripiprazole for schizophrenia for up to 6 months in study
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
SHANTI Clinical Trials
Colton, California, 92324, United States
Stanford University
Palo Alto, California, 94305, United States
Yale University
New Haven, Connecticut, 06519, United States
Mental Health Advocates
Boca Raton, Florida, 33431, United States
University of Miami School of Medicine
Miami, Florida, 33316, United States
Emory University
Atlanta, Georgia, 30329, United States
Medical College of Georgia
Augusta, Georgia, 30912, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Clinical Research Institute
Wichita, Kansas, 67207, United States
Lousiana State University Health Sciences Center
Shreveport, Louisiana, 71130, United States
Clinical Insights
Glen Burnie, Maryland, 21061, United States
Freedom Trail Clinic
Boston, Massachusetts, 02114, United States
John C Corrigan Community Mental Health Center
Fall River, Massachusetts, 02720, United States
University of Massachusetts
Worcester, Massachusetts, 01605, United States
Wayne State University
Detroit, Michigan, 48201, United States
University of Minnesota
Minneapolis, Minnesota, 55454, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
New Mexico VA Healthcare System
Albuquerque, New Mexico, 87108, United States
Research Foundation for Mental Hygiene
New York, New York, 10032, United States
University of Rochester
Rochester, New York, 14623, United States
John Umstead Hospital/Duke University
Butner, North Carolina, 27509, United States
The University of North Carolina
Chapel Hill, North Carolina, 27599-7160, United States
Carolinas HealthCare System
Charlotte, North Carolina, 28211, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Philadelphia VA Medical Center-116A
Philadelphia, Pennsylvania, 19104, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75235, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Related 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.
PMID: 21768610BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Open-label treatment is a limitation of this study, particularly for outcomes not measured in the laboratory but instead subject to clinical judgment.
Results Point of Contact
- Title
- Dr. Scott Stroup
- Organization
- Columbia University
Study Officials
- PRINCIPAL INVESTIGATOR
T. Scott Stroup, MD, MPH
Columbia University
- STUDY DIRECTOR
Joseph P. McEvoy, MD
Duke University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2007
First Posted
January 18, 2007
Study Start
January 1, 2007
Primary Completion
October 1, 2009
Study Completion
March 1, 2010
Last Updated
November 2, 2016
Results First Posted
December 19, 2012
Record last verified: 2010-11