Trial Outcomes & Findings for Effects of Divalproex Sodium on Food Intake, Energy Expenditure, and Posture Allocation (NCT NCT00287053)
NCT ID: NCT00287053
Last Updated: 2016-02-08
Results Overview
Change in food intake from baseline to week 3.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
57 participants
Primary outcome timeframe
February 2006 to September 2006
Results posted on
2016-02-08
Participant Flow
Participant milestones
| Measure |
1. Inactive Placebo Pill
Inactive placebo pill
|
2. Active Medication
Active medication
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
27
|
|
Overall Study
COMPLETED
|
26
|
26
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Divalproex Sodium on Food Intake, Energy Expenditure, and Posture Allocation
Baseline characteristics by cohort
| Measure |
1. Inactive Placebo Pill
n=30 Participants
Inactive placebo pill
|
2. Active Medication
n=27 Participants
Active medication
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
28.2 years
STANDARD_DEVIATION 8.6 • n=99 Participants
|
32 years
STANDARD_DEVIATION 10.2 • n=107 Participants
|
30.3 years
STANDARD_DEVIATION 9.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=99 Participants
|
27 participants
n=107 Participants
|
57 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: February 2006 to September 2006Change in food intake from baseline to week 3.
Outcome measures
| Measure |
1. Inactive Placebo Pill
n=26 Participants
Inactive placebo pill
|
2. Active Medication
n=26 Participants
Active medication
|
|---|---|---|
|
Change in Food Intake.
|
-51 kcal
Standard Error 60
|
-90 kcal
Standard Error 62
|
SECONDARY outcome
Timeframe: February 2006 to September 2006Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: February 2006 to September 2006Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: February 2006 to September 2006Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: February 2006 to September 2006Outcome measures
Outcome data not reported
Adverse Events
1. Inactive Placebo Pill
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2. Active Medication
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Corby Martin, Ph.D.; Assistant Professor
Pennington Biomedical Reseach Center
Phone: 225-763-2585
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place