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Effects of Divalproex Sodium on Food Intake, Energy Expenditure, and Posture Allocation
This study has been completed.
Study NCT00287053   Information provided by Pennington Biomedical Research Center
First Received: February 2, 2006   Last Updated: April 21, 2009   History of Changes
Study Type: Interventional
Study Design: Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Condition: Healthy
Intervention: Drug: divalproex sodium

  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
1 Divalproex Sodium
2 Placebo

Participant Flow:   Overall Study
  1 2
STARTED   30     27  
COMPLETED   26     26  
NOT COMPLETED   4     1  



  Baseline Characteristics
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Reporting Groups
  Description
1 Divalproex Sodium
2 Placebo

Baseline Measures
  1 2 Total
Number of Participants  
[units: participants]
30 27 57
Age  
[units: participants]
     
<=18 years 0 0 0
Between 18 and 65 years 30 27 57
>=65 years 0 0 0
Age  
[units: years]
Mean ± Standard Deviation
28.2 ± 8.6 32 ± 10.2 30.3 ± 9.5
Gender  
[units: participants]
     
Female 18 15 33
Male 12 12 24
Region of Enrollment  
[units: participants]
     
United States 30 27 57



  Outcome Measures

1.  Primary:   Change in Food Intake.   [ February 2006 to September 2006 ]


  Serious Adverse Events
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  Other Adverse Events
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