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
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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.
Stay Group Participants will continue treatment with olanzapine, quetiapine, or risperidone.

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  
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 ]

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
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Time Frame No text entered.
Additional Description No text entered.

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     77/106  
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



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