Effects of Divalproex Sodium on Food Intake, Energy Expenditure, and Posture Allocation - Full Text View

Sponsors and Collaborators:	Pennington Biomedical Research Center Abbott
Information provided by:	Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:	NCT00287053

Purpose

The purpose of the proposed study is to identify the mechanisms responsible for the weight gain associated with Depakote treatment, and to identify methods to prevent and treat weight gain in people taking Depakote. Both sides of the energy balance equation will be measured in a sample of healthy lean and overweight adults. Energy intake will be measured in the Pennington Center's Eating Laboratory, and total daily energy expenditure (TEE) and posture allocation will be measured with the IDEEA™. Questionnaires that assess food cravings and eating attitudes and behaviors will be used to determine if a behavioral phenotype is associated with weight gain in response to Depakote treatment. It is hypothesized that Depakote treatment will result in increased food intake. It is also hypothesized that the time spent engaging in sedentary behavior will increase in response to Depakote treatment. Time spent engaging in, and the energy expended during, physical activity is expected to decrease significantly. Therefore, it is hypothesized that TEE is expected to decrease significantly. The results will be used to identify specific behavioral targets to prevent weight gain during treatment with Depakote. Potential targets include interventions to modify food intake and physical activity. The degree to which each behavior (food intake or physical activity) will be targeted is dependent on the results of this study. For instance, if the majority of the weight gain associated with Depakote treatment is due to changes in food intake, stronger dietary interventions will be suggested. Additionally, changes in endocrine factors (hormones and peptides) will be evaluated during the study to determine if Depakote is associated with an altered endocrine response that affects satiety, food intake, or energy expenditure. If an altered endocrine response is found, these results will be used to identify adjunctive medications or compounds to correct the endocrine response and reduce weight gain. Genomic studies will also be possible, since gene sequencing and gene expression can be analyzed from archived buffy coat samples.

Condition	Intervention	Phase
Healthy	Drug: divalproex sodium	Phase IV

Drug Information available for: Divalproex sodium Valproate Sodium Valproic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Official Title:	Phase IV Study of the Effects of Divalproex Sodium on Food Intake and Energy Expenditure.

Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:

Change in food intake. [ Time Frame: February 2006 to September 2006 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in posture allocation and energy expenditure. [ Time Frame: February 2006 to September 2006 ] [ Designated as safety issue: No ]
Change in body weight. [ Time Frame: February 2006 to September 2006 ] [ Designated as safety issue: No ]
Endocrine response. [ Time Frame: February 2006 to September 2006 ] [ Designated as safety issue: No ]
Association of change with a behavioral phenotype. [ Time Frame: February 2006 to September 2006 ] [ Designated as safety issue: No ]

Enrollment:	58
Study Start Date:	February 2006
Study Completion Date:	October 2006
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Divalproex Sodium	Drug: divalproex sodium Divalproex sodium vs. placebo
2: Placebo Comparator Placebo	Drug: divalproex sodium Divalproex sodium vs. placebo

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Eligibility

Ages Eligible for Study:	18 Years to 54 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy male or female, age 18 to 54 years
20 < Body Mass Index (BMI, kg/m2) < 30
Willing to have a blood sample stored for possible future genetic testing

Exclusion Criteria:

For females, pregnant or unwilling to use an effective form of contraception while on this study (hormonal methods like birth control pills, implants or shots; barrier methods like condoms or diaphragms with foam; surgical sterilization; or abstinence)
For females, use of any other oral contraceptive other than monophasic oral contraceptives
For females, irregular menstrual cycles
For females, history of partial hysterectomy
For females, nursing
For females, history of polycystic ovarian syndrome
Aspirin use or the refusal to abstain from aspirin use during the study
Current or history of urea cycle disorders
Tobacco users
Use of anti-convulsant medication
Use of barbiturates, such as Phenobarbital
Use of tranquilizers, such as Xanax and Valium
Use of blood thinners, such as Coumadin
Use of anti-depressant medication
Liver disease or impaired liver function
History of pancreatitis
Regular (4 or more days per week) consumption of 3 or more alcoholic beverages a day
Refusal to abstain from alcohol intake during the study
Dietary restraint score > 14 or disinhibition score > 12 on the Eating Inventory [19]
Dislike or allergy to the food used during the food intake tests
Unwilling to wear an IDEEA™ during the study
Unwilling to wear an accelerometer during the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00287053

Locations

United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808

Sponsors and Collaborators

Pennington Biomedical Research Center

Abbott

Investigators

Principal Investigator:

Corby K. Martin, Ph.D.

Pennington Biomedical Research Center

More Information

Responsible Party:	Pennington Biomedical Research Center ( Corby Martin )
Study ID Numbers:	25031
Study First Received:	February 2, 2006
Last Updated:	January 28, 2008
ClinicalTrials.gov Identifier:	NCT00287053
Health Authority:	United States: Institutional Review Board

Keywords provided by Pennington Biomedical Research Center:

divalproex sodium
valproic acid
food intake

energy expenditure
posture allocation
None, the population of study is healthy

Study placed in the following topic categories:

Healthy
Valproic Acid

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Enzyme Inhibitors

Antimanic Agents
Pharmacologic Actions
Therapeutic Uses
GABA Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on January 16, 2009