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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 ]

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 ]

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 
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
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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.

Frequency Threshold
Threshold above which other adverse events are reported   2  

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

Other Adverse Events
    Switch Group   Stay Group
Total, other (not including serious) adverse events     
# participants affected / at risk   77/107 (71.96%)   77/106 (72.64%) 
Endocrine disorders     
Problems with sex drive †     
# participants affected / at risk   24/107 (22.43%)   26/106 (24.53%) 
# events   24   26 
Problems with sexual orgasm †     
# participants affected / at risk   20/107 (18.69%)   19/106 (17.92%) 
# events   20   19 
Problems with sexual arousal †     
# participants affected / at risk   20/107 (18.69%)   18/106 (16.98%) 
# events   20   18 
Menstrual irregularities †     
# participants affected / at risk   10/107 (9.35%)   6/106 (5.66%) 
# events   10   6 
Gynecomastia/galactorrhea †     
# participants affected / at risk   2/107 (1.87%)   4/106 (3.77%) 
# events   2   4 
Gastrointestinal disorders     
Dry mouth †     
# participants affected / at risk   24/107 (22.43%)   36/106 (33.96%) 
# events   24   36 
Constipation †     
# participants affected / at risk   20/107 (18.69%)   20/106 (18.87%) 
# events   20   20 
Nausea †     
# participants affected / at risk   12/107 (11.21%)   18/106 (16.98%) 
# events   12   18 
General disorders     
Increased appetite †     
# participants affected / at risk   18/107 (16.82%)   26/106 (24.53%) 
# events   18   26 
Weight gain †     
# participants affected / at risk   20/107 (18.69%)   21/106 (19.81%) 
# events   20   21 
Hypersomnia †     
# participants affected / at risk   16/107 (14.95%)   21/106 (19.81%) 
# events   16   21 
Orthostatic faintness †     
# participants affected / at risk   19/107 (17.76%)   18/106 (16.98%) 
# events   19   18 
Sialorrhea †     
# participants affected / at risk   8/107 (7.48%)   7/106 (6.60%) 
# events   8   7 
Nervous system disorders     
Akathisia/activation †     
# participants affected / at risk   29/107 (27.10%)   26/106 (24.53%) 
# events   29   26 
Akinesia †     
# participants affected / at risk   14/107 (13.08%)   25/106 (23.58%) 
# events   14   25 
Psychiatric disorders     
Insomnia †     
# participants affected / at risk   44/107 (41.12%)   29/106 (27.36%) 
# events   44   29 
Sleepiness †     
# participants affected / at risk   27/107 (25.23%)   35/106 (33.02%) 
# events   27   35 
Renal and urinary disorders     
Incontinence/nocturia †     
# participants affected / at risk   9/107 (8.41%)   13/106 (12.26%) 
# events   9   13 
Urinary hesistancy †     
# participants affected / at risk   5/107 (4.67%)   4/106 (3.77%) 
# events   5   4 
Skin and subcutaneous tissue disorders     
Skin rash †     
# participants affected / at risk   8/107 (7.48%)   12/106 (11.32%) 
# events   8   12 
Events were collected by systematic assessment



  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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