Status:
COMPLETED
Effects of Divalproex Sodium on Food Intake, Energy Expenditure, and Posture Allocation
Lead Sponsor:
Pennington Biomedical Research Center
Collaborating Sponsors:
Abbott
Conditions:
Healthy
Eligibility:
All Genders
18-54 years
Phase:
PHASE4
Brief Summary
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 t...
Detailed Description
Depakote (Abbott Laboratories, Abbott Park, IL) is an anti-convulsant medication used to treat epilepsy \[1\] and mania associated with bipolar disorder \[2, 3\]. Depakote also is used as a prophylaxi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00287053
Start Date
February 1 2006
End Date
October 1 2006
Last Update
February 8 2016
Active Locations (1)
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1
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808