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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: September 27, 2016
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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Switch Group 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.
Stay Group 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.

Participant Flow:   Overall Study
    Switch Group   Stay Group
STARTED   109   106 
COMPLETED   89   98 
NOT COMPLETED   20   8 



  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.
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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 
Overall Participants Analyzed 
[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:   Change in Non-HDL Cholesterol Level for Patients Assigned to Stay and Patients Assigned to Switch Over 24 Weeks   [ Time Frame: 24 weeks ]

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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  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.


Results Point of Contact:  
Name/Title: Dr. Scott Stroup
Organization: Columbia University
phone: 212-543-5676
e-mail: stroups@nyspi.columbia.edu


Publications:

Responsible Party: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00423878     History of Changes
Other Study ID Numbers: STROUP06STN0
DSIR AT-AP ( Other Identifier: National Institute of Mental Health )
Study First Received: January 16, 2007
Results First Received: November 16, 2012
Last Updated: September 27, 2016
Health Authority: United States: Federal Government