Effects of Divalproex Sodium on Food Intake, Energy Expenditure, and Posture Allocation

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by:
Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT00287053
First received: February 2, 2006
Last updated: September 13, 2010
Last verified: September 2010
Results First Received: April 21, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
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
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
1. Inactive Placebo Pill Inactive placebo pill
2. Active Medication Active medication

Participant Flow:   Overall Study
    1. Inactive Placebo Pill     2. Active Medication  
STARTED     30     27  
COMPLETED     26     26  
NOT COMPLETED     4     1  



  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
1. Inactive Placebo Pill Inactive placebo pill
2. Active Medication Active medication
Total Total of all reporting groups

Baseline Measures
    1. Inactive Placebo Pill     2. Active Medication     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.   [ Time Frame: February 2006 to September 2006 ]

2.  Secondary:   Change in Posture Allocation and Energy Expenditure.   [ Time Frame: February 2006 to September 2006 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Change in Body Weight.   [ Time Frame: February 2006 to September 2006 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Endocrine Response.   [ Time Frame: February 2006 to September 2006 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Association of Change With a Behavioral Phenotype.   [ Time Frame: February 2006 to September 2006 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  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
This was a short-term study; the long-term effects of this compound on energy balance require further study.


  More Information
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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: Corby Martin, Ph.D.; Assistant Professor
Organization: Pennington Biomedical Reseach Center
phone: 225-763-2585
e-mail: martinck@pbrc.edu


No publications provided by Pennington Biomedical Research Center

Publications automatically indexed to this study:

Responsible Party: Corby Martin, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT00287053     History of Changes
Other Study ID Numbers: 25031
Study First Received: February 2, 2006
Results First Received: April 21, 2009
Last Updated: September 13, 2010
Health Authority: United States: Institutional Review Board