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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00287053
First Posted: February 6, 2006
Last Update Posted: February 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Abbott
Information provided by (Responsible Party):
Corby K. Martin, Pennington Biomedical Research Center
Results First Submitted: April 21, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, 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 
Overall Participants Analyzed 
[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 reported.   Anticipated Reporting Date:   No text entered.  

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

4.  Secondary:   Endocrine Response.   [ Time Frame: February 2006 to September 2006 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

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


  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Corby K. Martin, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT00287053     History of Changes
Other Study ID Numbers: PBRC 25031
First Submitted: February 2, 2006
First Posted: February 6, 2006
Results First Submitted: April 21, 2009
Results First Posted: June 10, 2009
Last Update Posted: February 8, 2016