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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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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.
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 
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 ]
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Measure Type Primary
Measure Title Change in Non-HDL Cholesterol Level for Patients Assigned to Stay and Patients Assigned to Switch Over 24 Weeks
Measure Description Change in non-HDL cholesterol measured at baseline and every 4 weeks for 24 weeks. The efficacy analysis corresponded to a comparison of change in non-HDL cholesterol from baseline to 24 weeks between treatment groups (stay versus switch). Repeated measurements mixed effects linear models were fit for the primary analysis.
Time Frame 24 weeks  
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 efficacy evaluable 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 post-baseline 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 
Participants Analyzed 
[Units: Participants]
 89   98 
Change in Non-HDL Cholesterol Level for Patients Assigned to Stay and Patients Assigned to Switch Over 24 Weeks 
[Units: mg/dL non-HDL cholesterol]
Least Squares Mean (Standard Error)
 -20.2  (2.87)   -10.8  (2.57) 

No statistical analysis provided for Change in Non-HDL Cholesterol Level for Patients Assigned to Stay and Patients Assigned to Switch Over 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
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Time Frame No text entered.
Additional Description Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.

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

Serious Adverse Events
    Switch Group   Stay Group
Total, serious adverse events     
# participants affected / at risk   18/107 (16.82%)   9/106 (8.49%) 
Blood and lymphatic system disorders     
Agranulocytosis     
# participants affected / at risk   1/107 (0.93%)   0/106 (0.00%) 
# events   1   0 
Cardiac disorders     
Syncope     
# participants affected / at risk   0/107 (0.00%)   1/106 (0.94%) 
# events   0   1 
Gastrointestinal disorders     
Gastroenteritis     
# participants affected / at risk   1/107 (0.93%)   0/106 (0.00%) 
# events   1   0 
General disorders     
Slurred speech/sedation     
# participants affected / at risk   1/107 (0.93%)   0/106 (0.00%) 
# events   2   0 
Accidental overdose     
# participants affected / at risk   1/107 (0.93%)   1/106 (0.94%) 
# events   1   1 
Victim of gunshot wound     
# participants affected / at risk   1/107 (0.93%)   0/106 (0.00%) 
# events   1   0 
     
# participants affected / at risk   1/107 (0.93%)   1/106 (0.94%) 
# events   1   1 
Nervous system disorders     
Neuropathic pain     
# participants affected / at risk   1/107 (0.93%)   0/106 (0.00%) 
# events   1   0 
Psychiatric disorders     
Exacerbation of schizophrenia     
# participants affected / at risk   9/107 (8.41%)   3/106 (2.83%) 
# events   11   4 
Suicidality     
# participants affected / at risk   0/107 (0.00%)   2/106 (1.89%) 
# events   0   2 
Agitation     
# participants affected / at risk   1/107 (0.93%)   0/106 (0.00%) 
# events   2   0 
Respiratory, thoracic and mediastinal disorders     
Pneumonia     
# participants affected / at risk   1/107 (0.93%)   1/106 (0.94%) 
# events   1   1 
* Events were collected by non-systematic assessment




  Other Adverse Events


  Limitations and Caveats
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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.


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