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 ]

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Measure Type	Primary
Measure Title	Change in Food Intake.
Measure Description	Change in food intake from baseline to week 3.
Time Frame	February 2006 to September 2006
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.
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Reporting Groups

	Description
1	Divalproex Sodium
2	Placebo

Measured Values

	1	2
Number of Participants Analyzed [units: participants]	26	26
Change in Food Intake. [units: kcal] Least Squares Mean ± Standard Error	-51 ± 60	-90 ± 62

No statistical analysis provided for Change in Food Intake.

Serious Adverse Events

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Other Adverse Events

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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.

Limitations and Caveats

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
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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:

Martin CK, Han H, Anton SD, Greenway FL, Smith SR. Effect of valproic acid on body weight, food intake, physical activity and hormones: results of a randomized controlled trial. J Psychopharmacol. 2009 Sep;23(7):814-25. Epub 2008 Jun 26.

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