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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00423878
Recruitment Status : Completed
First Posted : January 18, 2007
Results First Posted : December 19, 2012
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
National Institute of Mental Health (NIMH)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Schizophrenia
Schizoaffective Disorder
Interventions: Drug: Risperidone
Drug: Olanzapine
Drug: Quetiapine
Drug: Aripiprazole

  Participant Flow

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
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 

  Baseline Characteristics

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
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 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   109   106   215 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 40  (11.7)   42  (10.5)   41  (11.1) 
[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

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

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.

  More Information

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


Responsible Party: National Institute of Mental Health (NIMH) Identifier: NCT00423878     History of Changes
Other Study ID Numbers: STROUP06STN0
DSIR AT-AP ( Other Identifier: National Institute of Mental Health )
First Submitted: January 16, 2007
First Posted: January 18, 2007
Results First Submitted: November 16, 2012
Results First Posted: December 19, 2012
Last Update Posted: November 2, 2016