Comparison of Antipsychotics for Metabolic Problems in Schizophrenia or Schizoaffective Disorder (CAMP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00423878
First received: January 16, 2007
Last updated: November 16, 2012
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
Drug: Risperidone
Drug: Olanzapine
Drug: Quetiapine
Drug: Aripiprazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Management of Metabolic Problems in Patients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Mean Difference in Non-HDL Cholesterol Level Changes Between Patients Assigned to Stay Compared to Patients Assigned to Switch at the Last Observation [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: Yes ]

Enrollment: 215
Study Start Date: January 2007
Study Completion Date: March 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: Aripiprazole
Switching medication to aripiprazole for schizophrenia for up to 6 months in study
Other Name: Abilify
Active Comparator: 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.
Drug: Risperidone
Continued treatment with the medication risperidone for schizophrenia for up to 6 months in study
Other Name: Risperdal
Drug: Olanzapine
Continued treatment with the medication olanzapine for schizophrenia for up to 6 months in study
Other Name: Zyprexa
Drug: Quetiapine
Continued treatment with the medication quetiapine for schizophrenia for up to 6 months in study
Other Name: Seroquel

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00423878

  Hide Study Locations
Locations
United States, California
SHANTI Clinical Trials
Colton, California, United States, 92324
Stanford University
Palo Alto, California, United States, 94305
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06519
United States, Florida
Mental Health Advocates
Boca Raton, Florida, United States, 33431
University of Miami School of Medicine
Miami, Florida, United States, 33316
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30329
Medical College of Georgia
Augusta, Georgia, United States, 30912
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Kansas
Clinical Research Institute
Wichita, Kansas, United States, 67207
United States, Louisiana
Lousiana State University Health Sciences Center
Shreveport, Louisiana, United States, 71130
United States, Maryland
Clinical Insights
Glen Burnie, Maryland, United States, 21061
United States, Massachusetts
Freedom Trail Clinic
Boston, Massachusetts, United States, 02114
John C Corrigan Community Mental Health Center
Fall River, Massachusetts, United States, 02720
University of Massachusetts
Worcester, Massachusetts, United States, 01605
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55454
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New Mexico
New Mexico VA Healthcare System
Albuquerque, New Mexico, United States, 87108
United States, New York
Research Foundation for Mental Hygiene
New York, New York, United States, 10032
University of Rochester
Rochester, New York, United States, 14623
United States, North Carolina
John Umstead Hospital/Duke University
Butner, North Carolina, United States, 27509
The University of North Carolina
Chapel Hill, North Carolina, United States, 27599-7160
Carolinas HealthCare System
Charlotte, North Carolina, United States, 28211
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
United States, Pennsylvania
Philadelphia VA Medical Center-116A
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75235
Baylor College of Medicine
Houston, Texas, United States, 77030
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Investigators
Principal Investigator: T. Scott Stroup, MD, MPH Columbia University
Study Director: Joseph P. McEvoy, MD Duke University
  More Information

No publications provided

Responsible Party: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00423878     History of Changes
Other Study ID Numbers: STROUP06STN0, DSIR AT-AP
Study First Received: January 16, 2007
Results First Received: November 16, 2012
Last Updated: November 16, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Disease
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Pathologic Processes
Risperidone
Aripiprazole
Quetiapine
Antipsychotic Agents
Olanzapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on October 19, 2014