Trial Outcomes & Findings for Double-blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression (NCT NCT00194116)
NCT ID: NCT00194116
Last Updated: 2019-07-17
Results Overview
MADRS total scores range from 0-60, where higher scores are indicative of more depression.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
54 participants
Primary outcome timeframe
Acute phase (week0-week6)
Results posted on
2019-07-17
Participant Flow
Participant milestones
| Measure |
Divalproex Sodium ER
Divalproex Sodium ER: Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.
|
Placebo
Placebo: . Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
28
|
|
Overall Study
COMPLETED
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
13
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Double-blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression
Baseline characteristics by cohort
| Measure |
Divalproex Sodium ER
n=26 Participants
Divalproex Sodium ER: Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.
|
Placebo
n=28 Participants
Placebo: . Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.7 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
38.8 years
STANDARD_DEVIATION 14.4 • n=7 Participants
|
39.2 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
DSM-IV Diagnosis
Bipolar I Disorder
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
DSM-IV Diagnosis
Bipolar II Disorder
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Acute phase (week0-week6)MADRS total scores range from 0-60, where higher scores are indicative of more depression.
Outcome measures
| Measure |
Divalproex Sodium ER
n=26 Participants
Divalproex Sodium ER: Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.
|
Placebo
n=28 Participants
Placebo: . Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.
|
|---|---|---|
|
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
|
-9.64 units on a scale
Standard Error 1.49
|
-5.32 units on a scale
Standard Error 1.40
|
SECONDARY outcome
Timeframe: Acute phase (week0-week6)YMRS Scores range from 0 to 60 where higher scores are indicative of more mania.
Outcome measures
| Measure |
Divalproex Sodium ER
n=26 Participants
Divalproex Sodium ER: Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.
|
Placebo
n=28 Participants
Placebo: . Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.
|
|---|---|---|
|
Change in Young Mania Rating Scale (YMRS) Total Score
|
-0.54 units on a scale
Standard Deviation 5.04
|
-0.46 units on a scale
Standard Deviation 3.28
|
SECONDARY outcome
Timeframe: Acute phase (week0-week6)Population: Not all subjects completed the GBI at study end point
GBI Depression Scale Scores range from 46-184, where higher scores are indicative of more depression.
Outcome measures
| Measure |
Divalproex Sodium ER
n=9 Participants
Divalproex Sodium ER: Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.
|
Placebo
n=8 Participants
Placebo: . Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.
|
|---|---|---|
|
Change in General Behavior Inventory (GBI) Depression Scale Score
|
-11.56 units on a scale
Standard Deviation 14.0
|
0.9 units on a scale
Standard Deviation 18.4
|
SECONDARY outcome
Timeframe: Acute phase (week0-week6)Population: Not all subjects completed the GBI at study end point
GBI Hypomanic/Biphasic Scale scores range from 28-112, where higher scores are indicative of more hypomanic/manic symptoms.
Outcome measures
| Measure |
Divalproex Sodium ER
n=9 Participants
Divalproex Sodium ER: Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.
|
Placebo
n=8 Participants
Placebo: . Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.
|
|---|---|---|
|
Change in General Behavior Inventory (GBI) Hypomanic/Biphasic Scale Score
|
-7.2 units on a scale
Standard Deviation 8.3
|
-6.8 units on a scale
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: Acute phase (week0-week6)Population: Not all subjects completed the SF-36 at study end point
SF-36 Physical Component Summary scores range from 0-100, with a higher score indicating better physical health.
Outcome measures
| Measure |
Divalproex Sodium ER
n=18 Participants
Divalproex Sodium ER: Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.
|
Placebo
n=14 Participants
Placebo: . Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.
|
|---|---|---|
|
Change in Short Form Health Survey (SF-36) Physical Component Summary Score
|
-3.4 units on a scale
Standard Deviation 15.7
|
-4.2 units on a scale
Standard Deviation 9.2
|
SECONDARY outcome
Timeframe: Acute phase (week0-week6)Population: Not all subjects completed the SF-36 at study end point
SF-36 Mental Component Summary scores range from 0-100, with a higher score indicating better mental health.
Outcome measures
| Measure |
Divalproex Sodium ER
n=18 Participants
Divalproex Sodium ER: Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.
|
Placebo
n=14 Participants
Placebo: . Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.
|
|---|---|---|
|
Change in Short Form Health Survey (SF-36) Mental Component Summary Score
|
17.9 units on a scale
Standard Deviation 18.4
|
13.5 units on a scale
Standard Deviation 15.7
|
SECONDARY outcome
Timeframe: Acute phase (week0-week6)HAMA Scores range from 0 to 56 where higher scores are indicative of more anxiety.
Outcome measures
| Measure |
Divalproex Sodium ER
n=26 Participants
Divalproex Sodium ER: Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.
|
Placebo
n=28 Participants
Placebo: . Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.
|
|---|---|---|
|
Change in Hamilton Anxiety Rating Scale (HAMA) Total Score
|
-4.6 units on a scale
Standard Deviation 4.6
|
-3.5 units on a scale
Standard Deviation 7.0
|
Adverse Events
Divalproex Sodium ER
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Divalproex Sodium ER
n=26 participants at risk
Divalproex Sodium ER: Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.
|
Placebo
n=28 participants at risk
Placebo: . Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
34.6%
9/26 • Number of events 26
|
14.3%
4/28 • Number of events 28
|
|
General disorders
Increased Appetite
|
15.4%
4/26 • Number of events 4
|
7.1%
2/28 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
11.5%
3/26 • Number of events 3
|
7.1%
2/28 • Number of events 2
|
|
General disorders
Fatigue
|
11.5%
3/26 • Number of events 3
|
10.7%
3/28 • Number of events 3
|
|
General disorders
Dry Mouth
|
11.5%
3/26 • Number of events 3
|
3.6%
1/28 • Number of events 1
|
|
Gastrointestinal disorders
Stomach Cramps
|
11.5%
3/26 • Number of events 3
|
0.00%
0/28
|
Additional Information
Dr. Keming Gao
Univeristy Hospitals Case Medical Center
Phone: 216-844-2865
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place