Trial Outcomes & Findings for Determining Metabolic Effects of Valproate and Antipsychotic Therapy (NCT NCT00167934)

NCT ID: NCT00167934

Last Updated: 2020-02-10

Results Overview

Change in body composition (total body fat) was assessed using dual energy x-ray absorptiometry

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 164 participants
• Primary outcome timeframe: Measured at baseline and Week 12
• Results posted on: 2020-02-10

Participant Flow

Participant milestones

Measure	Placebo 50% of participants will receive placebo	Experimental 50% of participants will receive Depakote ER
Overall Study STARTED	82	82
Overall Study COMPLETED	82	82
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Determining Metabolic Effects of Valproate and Antipsychotic Therapy

Baseline characteristics by cohort

Measure	Placebo n=25 Participants 50% of participants will receive placebo	Experimental n=25 Participants 50% of participants will receive Depakote ER	Total n=50 Participants Total of all reporting groups
Age, Continuous	40.6 years STANDARD_DEVIATION 10.1 • n=5 Participants	41.3 years STANDARD_DEVIATION 8.4 • n=7 Participants	40.9 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	6 participants n=5 Participants	7 participants n=7 Participants	13 participants n=5 Participants
Race/Ethnicity, Customized African American	19 participants n=5 Participants	18 participants n=7 Participants	37 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at baseline and Week 12

Change in body composition (total body fat) was assessed using dual energy x-ray absorptiometry

Outcome measures

Measure	Placebo n=24 Participants 50% of participants will receive placebo	Experimental n=22 Participants 50% of participants will receive Depakote ER
Change From Baseline in Total Body Fat Composition Using Dual Energy X-ray Absorptiometry at 12 Weeks	-0.51 percent change Standard Deviation 2.13	2.03 percent change Standard Deviation 2.17

PRIMARY outcome

Timeframe: Measured at baseline and Week 12

Outcome measures

Measure	Placebo n=25 Participants 50% of participants will receive placebo	Experimental n=25 Participants 50% of participants will receive Depakote ER
Effects of Medication on Insulin Secretion at Skeletal Muscle (Glucose Disposal)	0.27 percent change Standard Deviation 1.23	-0.35 percent change Standard Deviation 1.13

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Experimental

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=23 participants at risk 50% of participants will receive placebo	Experimental n=24 participants at risk 50% of participants will receive Depakote ER
General disorders Drowsiness/Somnolence	4.3% 1/23 • At 12 Week Assessment An Adverse Event Form is administered to participants by a trained rater.	8.3% 2/24 • At 12 Week Assessment An Adverse Event Form is administered to participants by a trained rater.
General disorders Tiredness/Fatigue	0.00% 0/23 • At 12 Week Assessment An Adverse Event Form is administered to participants by a trained rater.	12.5% 3/24 • At 12 Week Assessment An Adverse Event Form is administered to participants by a trained rater.
General disorders Anxiety	4.3% 1/23 • At 12 Week Assessment An Adverse Event Form is administered to participants by a trained rater.	8.3% 2/24 • At 12 Week Assessment An Adverse Event Form is administered to participants by a trained rater.
General disorders Restlessness	8.7% 2/23 • At 12 Week Assessment An Adverse Event Form is administered to participants by a trained rater.	8.3% 2/24 • At 12 Week Assessment An Adverse Event Form is administered to participants by a trained rater.
General disorders Tremor	0.00% 0/23 • At 12 Week Assessment An Adverse Event Form is administered to participants by a trained rater.	12.5% 3/24 • At 12 Week Assessment An Adverse Event Form is administered to participants by a trained rater.

Additional Information

Michael Yingling

Washington University School of Medicine

Phone: 573-579-1412

Email: yinglingm@wustl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place