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
Results First Received: November 16, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Schizophrenia
Schizoaffective Disorder
Interventions: Drug: Risperidone
Drug: Olanzapine
Drug: Quetiapine
Drug: Aripiprazole

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Switch Group Participants will switch to aripiprazole.
Stay Group Participants will continue treatment with olanzapine, quetiapine, or risperidone.
Total Total of all reporting groups

Baseline Measures
    Switch Group     Stay Group     Total  
Number of Participants  
[units: participants]
  109     106     215  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     109     106     215  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  40  ± 11.7     42  ± 10.5     41  ± 11.1  
Gender  
[units: participants]
     
Female     41     37     78  
Male     68     69     137  
Region of Enrollment  
[units: participants]
     
United States     109     106     215  
non-HDL cholesterol  
[units: mg/dL]
Mean ± Standard Deviation
  169  ± 31.9     176  ± 33.5     173  ± 32.8  



  Outcome Measures
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1.  Primary:   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 ]

Measure Type Primary
Measure Title Mean Difference in Non-HDL Cholesterol Level Changes Between Patients Assigned to Stay Compared to Patients Assigned to Switch at the Last Observation
Measure Description No text entered.
Time Frame Measured at Month 6  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The primary efficacy analysis was conducted on the efficacyevaluable population, defined as all patients randomly assigned to a study group who received at least one dose of study medication and completed at least one postbaseline efficacy assessment.

Reporting Groups
  Description
Switch Group Participants will switch to aripiprazole.
Stay Group Participants will continue treatment with olanzapine, quetiapine, or risperidone.

Measured Values
    Switch Group     Stay Group  
Number of Participants Analyzed  
[units: participants]
  89     98  
Mean Difference in Non-HDL Cholesterol Level Changes Between Patients Assigned to Stay Compared to Patients Assigned to Switch at the Last Observation  
[units: mg/dL non-HDL cholesterol]
Least Squares Mean ± Standard Error
  -20.2  ± 2.87     -10.8  ± 2.57  

No statistical analysis provided for Mean Difference in Non-HDL Cholesterol Level Changes Between Patients Assigned to Stay Compared to Patients Assigned to Switch at the Last Observation



2.  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)   [ Time Frame: Measured at Month 6 ]

Measure Type Secondary
Measure Title 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)
Measure Description No text entered.
Time Frame Measured at Month 6  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
2 participants who never took assigned study medication were excluded.

Reporting Groups
  Description
Switch Group Participants will switch to aripiprazole.
Stay Group Participants will continue treatment with olanzapine, quetiapine, or risperidone.

Measured Values
    Switch Group     Stay Group  
Number of Participants Analyzed  
[units: participants]
  107     106  
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)  
[units: participants]
  22     18  

No statistical analysis provided for 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)




  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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:  
Name/Title: Dr. Scott Stroup
Organization: Columbia University
phone: 212-543-5676
e-mail: stroups@nyspi.columbia.edu


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