Trial Outcomes & Findings for Depakote ER in Bipolar Depression (NCT NCT00186186)
NCT ID: NCT00186186
Last Updated: 2017-04-12
Results Overview
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression the overall score ranges from 0 to 60. Usual cutoff points are: 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \>34 - severe depression.
COMPLETED
PHASE4
28 participants
Baseline, 7 weeks
2017-04-12
Participant Flow
Eligible patients were recruited from the Bipolar Disorders Clinic at the Stanford University School of Medicine in Stanford, California. Patients met DSM-IV criteria for bipolar II disorder, with a current major depressive episode, as determined by the Systematic Treatment Enhancement for Bipolar Disorder (STEP-BD)
Participant milestones
| Measure |
Depakote ER
Open-label. All subjects received Depakote extended release (ER) starting 250mg/daily at bedtime. Dose was increased every 4 days by 250mg/day as necessary and tolerated up to 1500 mg/day. All subjects took medication over a period of 7 weeks or terminated at the final visit (whichever came first).
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Depakote ER
Open-label. All subjects received Depakote extended release (ER) starting 250mg/daily at bedtime. Dose was increased every 4 days by 250mg/day as necessary and tolerated up to 1500 mg/day. All subjects took medication over a period of 7 weeks or terminated at the final visit (whichever came first).
|
|---|---|
|
Overall Study
Lack of Efficacy
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Not reported as to reason
|
2
|
Baseline Characteristics
Depakote ER in Bipolar Depression
Baseline characteristics by cohort
| Measure |
Depakote ER
n=28 Participants
Depakote ER up to 1500 mg/day
Depakote ER: Depakote ER
|
|---|---|
|
Age, Continuous
|
36.7 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
|
Montgomery Asberg Depression Rating Scale (MADRS) Total Score
|
30.1 units on a scale
STANDARD_DEVIATION 4.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 7 weeksThe Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression the overall score ranges from 0 to 60. Usual cutoff points are: 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \>34 - severe depression.
Outcome measures
| Measure |
Depakote ER
n=20 Participants
Depakote ER up to 1500 mg/day
|
|---|---|
|
Montgomery Asberg Depression Rating Scale (MADRS)
|
14.9 units on a scale
Standard Deviation 9.8
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SECONDARY outcome
Timeframe: 7 weeksA reduction greater than or equal to 50% in MADRS total score from baseline to the endpoint.
Outcome measures
| Measure |
Depakote ER
n=20 Participants
Depakote ER up to 1500 mg/day
|
|---|---|
|
Response to the Divalproex-ER in Acute Bipolar 2 Depression.
|
11 participants
|
Adverse Events
Depakote ER
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Depakote ER
n=28 participants at risk
Depakote ER up to 1500 mg/day
|
|---|---|
|
Metabolism and nutrition disorders
Weight gain
|
10.7%
3/28 • Number of events 3
|
Additional Information
Dr. Terence Ketter, Chief Bipolar Disorder Clinic
Stanford University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place