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

January 16, 2007
November 16, 2012
January 2007
October 2009   (final data collection date for primary outcome measure)
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 ]
Mean difference in non-HDL cholesterol level changes between patients assigned to stay compared to patients assigned to switch at the last observation.
Complete list of historical versions of study NCT00423878 on ClinicalTrials.gov Archive Site
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 ]
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)
Not Provided
Not Provided
 
Comparison of Antipsychotics for Metabolic Problems in Schizophrenia or Schizoaffective Disorder
Clinical Management of Metabolic Problems in Patients With Schizophrenia

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Schizophrenia
  • Schizoaffective Disorder
  • 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
  • Drug: Aripiprazole
    Switching medication to aripiprazole for schizophrenia for up to 6 months in study
    Other Name: Abilify
  • 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
    Intervention: Drug: Aripiprazole
  • 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.
    Interventions:
    • Drug: Risperidone
    • Drug: Olanzapine
    • Drug: Quetiapine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
215
March 2010
October 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00423878
STROUP06STN0, DSIR AT-AP
Yes
National Institute of Mental Health (NIMH)
National Institute of Mental Health (NIMH)
Not Provided
Principal Investigator: T. Scott Stroup, MD, MPH Columbia University
Study Director: Joseph P. McEvoy, MD Duke University
National Institute of Mental Health (NIMH)
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP