Trial Outcomes & Findings for A Clinical Trial of Oral Ganaxolone in Women With Postpartum Depression (NCT NCT03460756)
NCT ID: NCT03460756
Last Updated: 2023-08-18
Results Overview
The HAMD17 was a 17-item clinician-rated instrument used to assess the range of symptoms that were most frequently observed in participants with major depression. All items were scored on an ordinal scale between 0 and 4 (8 items) or 0 and 2 (9 items) of increasing severity. Each of 17 items was rated by clinician with rating of 0: absent, 1: doubtful to mild, 2: mild to moderate, 3: moderate to severe, and 4: very severe. A total score (0 to 52) was calculated by adding scores of all 17 items, where 0 indicated no depression and 52 indicated severe depression. Higher score represented more severe condition. Baseline was defined as the Day 1 assessment before study drug infusion. Change from Baseline is defined as post dose visit value minus Baseline value.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
84 participants
Primary outcome timeframe
Baseline (Day 1) and through Day 10 for 2 week treatment group and Day 29 for 4 week treatment groups
Results posted on
2023-08-18
Participant Flow
Participant milestones
| Measure |
TID (2-week)
Oral ganaxolone doses were titrated over 6 days to a daily dose of 900 milligrams/ day (mg/day) (3 divided doses) and was maintained until Day 10, followed by a taper over 4 days
|
QHS (2-week)
Oral ganaxolone doses were titrated to a daily dose of 675 mg/day approximately 10 PM or before going to bed for the night (QHS) over 4 days, which was maintained until Day 10, followed by a taper over 4 days
|
QHS (4-week)
Oral ganaxolone doses were titrated to a daily dose of 675 mg/day QHS for 28 days, followed by a taper over 4 days.
|
1125 mg (4-week)
Oral ganaxolone was dosed as 675 mg at approximately 7 PM or with supper (Q7PM) and QHS (for a total of 1,350 mg/day on the first 2 days), followed by a daily dose of 1,125 mg/day at Q7PM for 26 days and a taper over 4 days
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
14
|
25
|
43
|
|
Overall Study
COMPLETED
|
2
|
9
|
16
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
5
|
9
|
9
|
Reasons for withdrawal
| Measure |
TID (2-week)
Oral ganaxolone doses were titrated over 6 days to a daily dose of 900 milligrams/ day (mg/day) (3 divided doses) and was maintained until Day 10, followed by a taper over 4 days
|
QHS (2-week)
Oral ganaxolone doses were titrated to a daily dose of 675 mg/day approximately 10 PM or before going to bed for the night (QHS) over 4 days, which was maintained until Day 10, followed by a taper over 4 days
|
QHS (4-week)
Oral ganaxolone doses were titrated to a daily dose of 675 mg/day QHS for 28 days, followed by a taper over 4 days.
|
1125 mg (4-week)
Oral ganaxolone was dosed as 675 mg at approximately 7 PM or with supper (Q7PM) and QHS (for a total of 1,350 mg/day on the first 2 days), followed by a daily dose of 1,125 mg/day at Q7PM for 26 days and a taper over 4 days
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
2
|
1
|
|
Overall Study
Pregnancy
|
0
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
4
|
7
|
3
|
Baseline Characteristics
A Clinical Trial of Oral Ganaxolone in Women With Postpartum Depression
Baseline characteristics by cohort
| Measure |
TID (2-week)
n=2 Participants
Oral ganaxolone doses were titrated to a daily dose of 900 mg/day Oral ganaxolone doses were titrated to a daily dose of 675 mg/day QHS over 4 days, which was maintained until Day 10, followed by a taper over 4 days
|
QHS (2-week)
n=14 Participants
Oral ganaxolone doses were titrated to a daily dose of 675 mg/day QHS over 4 days, which was maintained until Day 10, followed by a taper over 4 days
|
QHS (4-week)
n=25 Participants
Oral ganaxolone was dosed at a daily dose of 675 mg/day QHS for 28 days, followed by a taper over 4 days
|
1125 mg (4-week)
n=43 Participants
Oral ganaxolone was dosed as 675 mg at approximately 7 PM or with supper (Q7PM) and QHS (for a total of 1,350 mg/day on the first 2 days), followed by a daily dose of 1,125 mg/day at Q7PM for 26 days and a taper over 4 days
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
23.5 years
STANDARD_DEVIATION 7.78 • n=5 Participants
|
27.5 years
STANDARD_DEVIATION 7.27 • n=7 Participants
|
27.4 years
STANDARD_DEVIATION 5.27 • n=5 Participants
|
28.0 years
STANDARD_DEVIATION 5.72 • n=4 Participants
|
27.7 years
STANDARD_DEVIATION 5.84 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
84 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 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
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and through Day 10 for 2 week treatment group and Day 29 for 4 week treatment groupsPopulation: Safety Set was defined as all participants who were dispensed study drug. Only those participants with HAMD17 response through treatment have been presented.
The HAMD17 was a 17-item clinician-rated instrument used to assess the range of symptoms that were most frequently observed in participants with major depression. All items were scored on an ordinal scale between 0 and 4 (8 items) or 0 and 2 (9 items) of increasing severity. Each of 17 items was rated by clinician with rating of 0: absent, 1: doubtful to mild, 2: mild to moderate, 3: moderate to severe, and 4: very severe. A total score (0 to 52) was calculated by adding scores of all 17 items, where 0 indicated no depression and 52 indicated severe depression. Higher score represented more severe condition. Baseline was defined as the Day 1 assessment before study drug infusion. Change from Baseline is defined as post dose visit value minus Baseline value.
Outcome measures
| Measure |
TID (2-week)
n=2 Participants
Oral ganaxolone doses were titrated to a daily dose of 900 mg/day (in 3 divided doses) and was maintained until Day 10, followed by a taper over 4 days
|
QHS (2-week)
n=13 Participants
Oral ganaxolone doses were titrated to a daily dose of 675 mg/day QHS over 4 days, which was maintained until Day 10, followed by a taper over 4 days
|
QHS (4-week)
n=23 Participants
Oral ganaxolone doses were titrated to a daily dose of 675 mg/day QHS for 28 days, followed by a taper over 4 days
|
1125 mg (4-week)
n=42 Participants
Oral ganaxolone was dosed as 675 mg at approximately 7 PM or with supper (Q7PM) and QHS (for a total of 1,350 mg/day on the first 2 days), followed by a daily dose of 1,125 mg/day at Q7PM for 26 days and a taper over 4 days
|
|---|---|---|---|---|
|
Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) Through Treatment
Day 2/4
|
-8.0 score on a scale
Standard Deviation 9.90
|
-5.7 score on a scale
Standard Deviation 4.87
|
-0.8 score on a scale
Standard Deviation 3.19
|
-2.6 score on a scale
Standard Deviation 5.46
|
|
Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) Through Treatment
Day 15/17
|
-9.5 score on a scale
Standard Deviation 9.19
|
-8.8 score on a scale
Standard Deviation 7.12
|
-9.7 score on a scale
Standard Deviation 7.36
|
-9.4 score on a scale
Standard Deviation 7.94
|
|
Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) Through Treatment
Day 29
|
—
|
—
|
-12.2 score on a scale
Standard Deviation 8.40
|
-14.0 score on a scale
Standard Deviation 7.64
|
|
Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) Through Treatment
Day 7
|
-15.0 score on a scale
Standard Deviation 12.73
|
-6.7 score on a scale
Standard Deviation 7.93
|
—
|
—
|
|
Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) Through Treatment
Day 8/10
|
-3.0 score on a scale
Standard Deviation 0
|
-10.5 score on a scale
Standard Deviation 7.21
|
-6.8 score on a scale
Standard Deviation 7.25
|
-10.2 score on a scale
Standard Deviation 7.44
|
|
Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) Through Treatment
Day 22
|
—
|
—
|
-10.3 score on a scale
Standard Deviation 5.94
|
-12.0 score on a scale
Standard Deviation 7.98
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Through Day 38 for 2 week treatment group and Day 71 and 119 for 4 week treatment groupsPopulation: Safety Set. Only those participants with HAMD17 response post treatment have been presented.
The HAMD17 was a 17-item clinician-rated instrument used to assess the range of symptoms that were most frequently observed in participants with major depression. All items were scored on an ordinal scale between 0 and 4 (8 items) or 0 and 2 (9 items) of increasing severity. Each of 17 items was rated by clinician with rating of 0: absent, 1: doubtful to mild, 2: mild to moderate, 3: moderate to severe, and 4: very severe. A total score (0 to 52) was calculated by adding scores of all 17 items, where 0 indicated no depression and 52 indicated severe depression. Higher score represented more severe condition. Baseline was defined as the Day 1 assessment before study drug infusion. Change from Baseline is defined as post dose visit value minus Baseline value.
Outcome measures
| Measure |
TID (2-week)
n=2 Participants
Oral ganaxolone doses were titrated to a daily dose of 900 mg/day (in 3 divided doses) and was maintained until Day 10, followed by a taper over 4 days
|
QHS (2-week)
n=8 Participants
Oral ganaxolone doses were titrated to a daily dose of 675 mg/day QHS over 4 days, which was maintained until Day 10, followed by a taper over 4 days
|
QHS (4-week)
n=20 Participants
Oral ganaxolone doses were titrated to a daily dose of 675 mg/day QHS for 28 days, followed by a taper over 4 days
|
1125 mg (4-week)
n=36 Participants
Oral ganaxolone was dosed as 675 mg at approximately 7 PM or with supper (Q7PM) and QHS (for a total of 1,350 mg/day on the first 2 days), followed by a daily dose of 1,125 mg/day at Q7PM for 26 days and a taper over 4 days
|
|---|---|---|---|---|
|
Change From Baseline in Hamilton Depression Rating Scale 17-item Version Post Treatment
Day 57/59
|
—
|
—
|
-13.2 score on a scale
Standard Deviation 8.20
|
-12.3 score on a scale
Standard Deviation 9.11
|
|
Change From Baseline in Hamilton Depression Rating Scale 17-item Version Post Treatment
Day 36/38
|
-19.0 score on a scale
Standard Deviation 7.07
|
-7.1 score on a scale
Standard Deviation 8.44
|
-14.6 score on a scale
Standard Deviation 9.63
|
-12.4 score on a scale
Standard Deviation 8.82
|
|
Change From Baseline in Hamilton Depression Rating Scale 17-item Version Post Treatment
Day 71
|
—
|
—
|
—
|
-12.2 score on a scale
Standard Deviation 8.45
|
|
Change From Baseline in Hamilton Depression Rating Scale 17-item Version Post Treatment
Day 89
|
—
|
—
|
-14.2 score on a scale
Standard Deviation 9.98
|
—
|
|
Change From Baseline in Hamilton Depression Rating Scale 17-item Version Post Treatment
Day 119
|
—
|
—
|
-20.5 score on a scale
Standard Deviation 6.59
|
—
|
SECONDARY outcome
Timeframe: Day 2 (all treatment groups), Day 7 (TID & QHS), Day 8/10 (all treatment groups), Day 15/17 (all treatment groups), Day 22 and 29 (QHS, 1125mg), Day 36/38 (all treatment groups), Day 57/59 (QHS, 1125mg), Day 71 (1125mg), Day 89 (QHS), Day 119 (QHS)Population: Safety Set. Only those participants with data available at specified timepoints have been presented.
HAMD17 Response was defined as ≥50% reduction from Baseline in total score. The HAMD-17 is a 17-item assessment used to assess the severity of depression and its improvement during the course of therapy. Each item was evaluated and scored using either a 5-point scale of 0 (not present/absent) to 4 (very severe) or a 3-point scale of 0 (not present/absent) to 2 (marked). Items rated on the 3-point scale include: insomnia early, middle, late; somatic symptoms gastrointestinal and general; genital symptoms; loss of weight; insight. Items rated on 5-point scale include: depressed mood; feelings of guilt; suicide; work and activities; retardation; agitation; anxiety psychic and somatic; hypochondriasis. The total score was the sum of the scores from HAMD-17 Items 1 through 17 and ranged from 0 (not at all depressed) to 52 (severely depressed). Higher scores indicate greater symptom severity. Number of participants with response to HAMD-17 has been presented.
Outcome measures
| Measure |
TID (2-week)
n=2 Participants
Oral ganaxolone doses were titrated to a daily dose of 900 mg/day (in 3 divided doses) and was maintained until Day 10, followed by a taper over 4 days
|
QHS (2-week)
n=13 Participants
Oral ganaxolone doses were titrated to a daily dose of 675 mg/day QHS over 4 days, which was maintained until Day 10, followed by a taper over 4 days
|
QHS (4-week)
n=23 Participants
Oral ganaxolone doses were titrated to a daily dose of 675 mg/day QHS for 28 days, followed by a taper over 4 days
|
1125 mg (4-week)
n=42 Participants
Oral ganaxolone was dosed as 675 mg at approximately 7 PM or with supper (Q7PM) and QHS (for a total of 1,350 mg/day on the first 2 days), followed by a daily dose of 1,125 mg/day at Q7PM for 26 days and a taper over 4 days
|
|---|---|---|---|---|
|
Number of Participants With Response to Hamilton Depression Rating Scale 17 Item (HAMD17)
Day 8/10 - Response
|
0 Participants
|
4 Participants
|
7 Participants
|
12 Participants
|
|
Number of Participants With Response to Hamilton Depression Rating Scale 17 Item (HAMD17)
Day 36/38 - Response
|
2 Participants
|
3 Participants
|
12 Participants
|
17 Participants
|
|
Number of Participants With Response to Hamilton Depression Rating Scale 17 Item (HAMD17)
Day 57/59 - Response
|
—
|
—
|
8 Participants
|
18 Participants
|
|
Number of Participants With Response to Hamilton Depression Rating Scale 17 Item (HAMD17)
Day 89 - Response
|
—
|
—
|
9 Participants
|
—
|
|
Number of Participants With Response to Hamilton Depression Rating Scale 17 Item (HAMD17)
Day 2/4 - Response
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Response to Hamilton Depression Rating Scale 17 Item (HAMD17)
Day 7 - Response
|
1 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants With Response to Hamilton Depression Rating Scale 17 Item (HAMD17)
Day 15/17 - Response
|
1 Participants
|
4 Participants
|
7 Participants
|
16 Participants
|
|
Number of Participants With Response to Hamilton Depression Rating Scale 17 Item (HAMD17)
Day 22 - Response
|
—
|
—
|
8 Participants
|
20 Participants
|
|
Number of Participants With Response to Hamilton Depression Rating Scale 17 Item (HAMD17)
Day 29 - Response
|
—
|
—
|
10 Participants
|
22 Participants
|
|
Number of Participants With Response to Hamilton Depression Rating Scale 17 Item (HAMD17)
Day 71 - Response
|
—
|
—
|
—
|
13 Participants
|
|
Number of Participants With Response to Hamilton Depression Rating Scale 17 Item (HAMD17)
Day 119 - Response
|
—
|
—
|
10 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 8/10 (all treatment arms), Day 15/17 (all treatment arms), Day 22 and 29 (QHS & 1125mg), Day 36/38 (all treatment arms), Day 57/59 (QHS & 1125mg), Day 71 (1125mg), Day 89 & 119 (QHS)Population: Safety Set. Only those participants with data available at specified timepoints have been presented.
Remission was defined as an observed total score of 0 to 7. The HAMD-17 is a 17-item assessment used to assess the severity of depression and its improvement during the course of therapy. Each item was evaluated and scored using either a 5-point scale of 0 (not present/absent) to 4 (very severe) or a 3-point scale of 0 (not present/absent) to 2 (marked). Items rated on the 3-point scale include: insomnia early, middle, late; somatic symptoms gastrointestinal and general; genital symptoms; loss of weight; insight. Items rated on 5-point scale include: depressed mood; feelings of guilt; suicide; work and activities; retardation; agitation; anxiety psychic and somatic; hypochondriasis. The total score was the sum of the scores from HAMD-17 Items 1 through 17 and ranged from 0 (not at all depressed) to 52 (severely depressed). Higher scores indicate greater symptom severity. Number of participants with HAMD-17 remission has been presented.
Outcome measures
| Measure |
TID (2-week)
n=2 Participants
Oral ganaxolone doses were titrated to a daily dose of 900 mg/day (in 3 divided doses) and was maintained until Day 10, followed by a taper over 4 days
|
QHS (2-week)
n=11 Participants
Oral ganaxolone doses were titrated to a daily dose of 675 mg/day QHS over 4 days, which was maintained until Day 10, followed by a taper over 4 days
|
QHS (4-week)
n=23 Participants
Oral ganaxolone doses were titrated to a daily dose of 675 mg/day QHS for 28 days, followed by a taper over 4 days
|
1125 mg (4-week)
n=39 Participants
Oral ganaxolone was dosed as 675 mg at approximately 7 PM or with supper (Q7PM) and QHS (for a total of 1,350 mg/day on the first 2 days), followed by a daily dose of 1,125 mg/day at Q7PM for 26 days and a taper over 4 days
|
|---|---|---|---|---|
|
Number of Participants With Hamilton Depression Rating Scale 17-item Remission
Day 36/38 - Remission
|
1 Participants
|
1 Participants
|
9 Participants
|
11 Participants
|
|
Number of Participants With Hamilton Depression Rating Scale 17-item Remission
Day 57/59 - Remission
|
—
|
—
|
5 Participants
|
12 Participants
|
|
Number of Participants With Hamilton Depression Rating Scale 17-item Remission
Day 8/10 - Remission
|
0 Participants
|
1 Participants
|
1 Participants
|
8 Participants
|
|
Number of Participants With Hamilton Depression Rating Scale 17-item Remission
Day 15/17 - Remission
|
0 Participants
|
2 Participants
|
4 Participants
|
8 Participants
|
|
Number of Participants With Hamilton Depression Rating Scale 17-item Remission
Day 22 - Remission
|
—
|
—
|
3 Participants
|
10 Participants
|
|
Number of Participants With Hamilton Depression Rating Scale 17-item Remission
Day 29 - Remission
|
—
|
—
|
7 Participants
|
14 Participants
|
|
Number of Participants With Hamilton Depression Rating Scale 17-item Remission
Day 71 - Remission
|
—
|
—
|
—
|
9 Participants
|
|
Number of Participants With Hamilton Depression Rating Scale 17-item Remission
Day 89 - Remission
|
—
|
—
|
7 Participants
|
—
|
|
Number of Participants With Hamilton Depression Rating Scale 17-item Remission
Day 119 - Remission
|
—
|
—
|
8 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) through Day 119Population: Safety Set. Only those participants with data available at specified timepoints has been presented.
The EPDS is a validated 10-question depression assessment for postpartum women, which includes anxiety symptoms and excludes constitutional symptoms associated with depression common in the postpartum period, such as changes in sleeping patterns. It consists of 10 multiple choice questions with scores for each question ranging from 0-3. Questions 1, 2, \& 4 are scored 0, 1, 2 or 3 with top box scored as 0 and the bottom box scored as 3. Questions 3 and 5 to 10 are reverse scored, with the top box scored as a 3 and the bottom box scored as 0. Scores are then summed for a total score, which ranges from 0: no depression to 30: severe depression. Higher score indicates severe depression. Baseline was defined as the Day 1 assessment before study drug infusion. Change from Baseline is defined as post dose visit value minus Baseline value.
Outcome measures
| Measure |
TID (2-week)
n=2 Participants
Oral ganaxolone doses were titrated to a daily dose of 900 mg/day (in 3 divided doses) and was maintained until Day 10, followed by a taper over 4 days
|
QHS (2-week)
n=12 Participants
Oral ganaxolone doses were titrated to a daily dose of 675 mg/day QHS over 4 days, which was maintained until Day 10, followed by a taper over 4 days
|
QHS (4-week)
n=24 Participants
Oral ganaxolone doses were titrated to a daily dose of 675 mg/day QHS for 28 days, followed by a taper over 4 days
|
1125 mg (4-week)
n=42 Participants
Oral ganaxolone was dosed as 675 mg at approximately 7 PM or with supper (Q7PM) and QHS (for a total of 1,350 mg/day on the first 2 days), followed by a daily dose of 1,125 mg/day at Q7PM for 26 days and a taper over 4 days
|
|---|---|---|---|---|
|
Change From Baseline in Edinburgh Postnatal Depression Scale (EPDS) Total Score
Day 2/4
|
-0.5 Score on a scale
Standard Error 2.12
|
-1.4 Score on a scale
Standard Error 2.19
|
-0.8 Score on a scale
Standard Error 1.18
|
-0.6 Score on a scale
Standard Error 1.64
|
|
Change From Baseline in Edinburgh Postnatal Depression Scale (EPDS) Total Score
Day 8/10
|
-3.0 Score on a scale
Standard Error NA
NA indicates standard error could not be calculated for single participant.
|
-1.3 Score on a scale
Standard Error 1.57
|
-1.5 Score on a scale
Standard Error 1.74
|
-2.3 Score on a scale
Standard Error 2.01
|
|
Change From Baseline in Edinburgh Postnatal Depression Scale (EPDS) Total Score
Day 36/38
|
-2.0 Score on a scale
Standard Error 2.83
|
-2.6 Score on a scale
Standard Error 1.85
|
-3.1 Score on a scale
Standard Error 2.77
|
-3.7 Score on a scale
Standard Error 2.64
|
|
Change From Baseline in Edinburgh Postnatal Depression Scale (EPDS) Total Score
Day 57/59
|
—
|
—
|
-2.5 Score on a scale
Standard Error 2.46
|
-3.4 Score on a scale
Standard Error 2.68
|
|
Change From Baseline in Edinburgh Postnatal Depression Scale (EPDS) Total Score
Day 7
|
-2.0 Score on a scale
Standard Error 2.83
|
-2.3 Score on a scale
Standard Error 2.06
|
—
|
—
|
|
Change From Baseline in Edinburgh Postnatal Depression Scale (EPDS) Total Score
Day 15/17
|
-5.0 Score on a scale
Standard Error 0.00
|
-2.6 Score on a scale
Standard Error 1.63
|
-1.8 Score on a scale
Standard Error 2.17
|
-2.2 Score on a scale
Standard Error 2.38
|
|
Change From Baseline in Edinburgh Postnatal Depression Scale (EPDS) Total Score
Day 22
|
—
|
—
|
-2.7 Score on a scale
Standard Error 2.18
|
-3.0 Score on a scale
Standard Error 2.62
|
|
Change From Baseline in Edinburgh Postnatal Depression Scale (EPDS) Total Score
Day 29
|
—
|
—
|
-2.9 Score on a scale
Standard Error 2.79
|
-3.1 Score on a scale
Standard Error 2.77
|
|
Change From Baseline in Edinburgh Postnatal Depression Scale (EPDS) Total Score
Day 71
|
—
|
—
|
—
|
-3.3 Score on a scale
Standard Error 2.31
|
|
Change From Baseline in Edinburgh Postnatal Depression Scale (EPDS) Total Score
Day 89
|
—
|
—
|
-2.6 Score on a scale
Standard Error 2.41
|
—
|
|
Change From Baseline in Edinburgh Postnatal Depression Scale (EPDS) Total Score
Day 119
|
—
|
—
|
-3.3 Score on a scale
Standard Error 3.20
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) through Day 119Population: Safety Set. Only those participants with data available at specified timepoints has been analyzed.
The Spielberger State-Trait Anxiety Inventory was a 6-item questionnaire designed and validated. It is a reliable and sensitive measure of anxiety. The 6-item version has been shown to have acceptable reliability, producing similar scores as the full 20-item inventory for those with normal and raised levels of anxiety. Participants are prompted to respond to indicate "how \[the participant\] feel right now, at this moment", followed by a list of common experiences like "I feel calm, I am tense, I feel upset, I am relaxed I feel content and I am worried." Responses range from Not at all (1) to Very much (4), with overall scores ranging from 20-80, where higher scores reflected higher states of anxiety. Baseline was defined as the Day 1 assessment before study drug infusion. Change from Baseline is defined as post dose visit value minus Baseline value.
Outcome measures
| Measure |
TID (2-week)
n=2 Participants
Oral ganaxolone doses were titrated to a daily dose of 900 mg/day (in 3 divided doses) and was maintained until Day 10, followed by a taper over 4 days
|
QHS (2-week)
n=12 Participants
Oral ganaxolone doses were titrated to a daily dose of 675 mg/day QHS over 4 days, which was maintained until Day 10, followed by a taper over 4 days
|
QHS (4-week)
n=24 Participants
Oral ganaxolone doses were titrated to a daily dose of 675 mg/day QHS for 28 days, followed by a taper over 4 days
|
1125 mg (4-week)
n=42 Participants
Oral ganaxolone was dosed as 675 mg at approximately 7 PM or with supper (Q7PM) and QHS (for a total of 1,350 mg/day on the first 2 days), followed by a daily dose of 1,125 mg/day at Q7PM for 26 days and a taper over 4 days
|
|---|---|---|---|---|
|
Change From Baseline in Spielberger State-Trait Anxiety Inventory, 6-item Version
Day 2/4
|
-11.7 Scores on a scale
Standard Error 11.81
|
-6.4 Scores on a scale
Standard Error 11.77
|
-1.8 Scores on a scale
Standard Error 11.45
|
-9.9 Scores on a scale
Standard Error 14.84
|
|
Change From Baseline in Spielberger State-Trait Anxiety Inventory, 6-item Version
Day 15/17
|
-33.3 Scores on a scale
Standard Error 9.48
|
-14.8 Scores on a scale
Standard Error 13.45
|
-14.5 Scores on a scale
Standard Error 17.58
|
-15.2 Scores on a scale
Standard Error 19.97
|
|
Change From Baseline in Spielberger State-Trait Anxiety Inventory, 6-item Version
Day 22
|
—
|
—
|
-13.0 Scores on a scale
Standard Error 17.48
|
-21.8 Scores on a scale
Standard Error 19.81
|
|
Change From Baseline in Spielberger State-Trait Anxiety Inventory, 6-item Version
Day 119
|
—
|
—
|
-16.7 Scores on a scale
Standard Error 17.45
|
—
|
|
Change From Baseline in Spielberger State-Trait Anxiety Inventory, 6-item Version
Day 7
|
-11.7 Scores on a scale
Standard Error 7.00
|
-9.0 Scores on a scale
Standard Error 11.86
|
—
|
—
|
|
Change From Baseline in Spielberger State-Trait Anxiety Inventory, 6-item Version
Day 8/10
|
-20.0 Scores on a scale
Standard Error NA
NA indicates standard error could not be calculated for single participant.
|
-5.7 Scores on a scale
Standard Error 11.00
|
-11.8 Scores on a scale
Standard Error 12.40
|
-16.8 Scores on a scale
Standard Error 17.53
|
|
Change From Baseline in Spielberger State-Trait Anxiety Inventory, 6-item Version
Day 29
|
—
|
—
|
-17.13 Scores on a scale
Standard Error 17.94
|
-21.4 Scores on a scale
Standard Error 20.34
|
|
Change From Baseline in Spielberger State-Trait Anxiety Inventory, 6-item Version
Day 36/38
|
-31.7 Scores on a scale
Standard Error 2.33
|
-11.3 Scores on a scale
Standard Error 5.31
|
-20.5 Scores on a scale
Standard Error 17.62
|
-23.2 Scores on a scale
Standard Error 18.96
|
|
Change From Baseline in Spielberger State-Trait Anxiety Inventory, 6-item Version
Day 57/59
|
—
|
—
|
-16.3 Scores on a scale
Standard Error 15.52
|
-22.8 Scores on a scale
Standard Error 19.72
|
|
Change From Baseline in Spielberger State-Trait Anxiety Inventory, 6-item Version
Day 71
|
—
|
—
|
—
|
-19.2 Scores on a scale
Standard Error 18.75
|
|
Change From Baseline in Spielberger State-Trait Anxiety Inventory, 6-item Version
Day 89
|
—
|
—
|
-14.7 Scores on a scale
Standard Error 18.52
|
—
|
SECONDARY outcome
Timeframe: Baseline through Day 119Population: Safety Set. Only those participants with data available at specified timepoints has been presented.
The CGI-I scale is a clinician-rated 7-point scale used to assess how much the participant's illness had improved or worsened relative to a Baseline state at the beginning of the intervention. It was rated as: 1. "very much improved" 2. "much improved" 3. "minimally improved" 4. "no change" 5. "minimally worse" 6. "much worse" 7. "very much worse". Higher scores indicated worse condition. Only those participants with CGI- improvement have been presented.
Outcome measures
| Measure |
TID (2-week)
n=2 Participants
Oral ganaxolone doses were titrated to a daily dose of 900 mg/day (in 3 divided doses) and was maintained until Day 10, followed by a taper over 4 days
|
QHS (2-week)
n=14 Participants
Oral ganaxolone doses were titrated to a daily dose of 675 mg/day QHS over 4 days, which was maintained until Day 10, followed by a taper over 4 days
|
QHS (4-week)
n=25 Participants
Oral ganaxolone doses were titrated to a daily dose of 675 mg/day QHS for 28 days, followed by a taper over 4 days
|
1125 mg (4-week)
n=43 Participants
Oral ganaxolone was dosed as 675 mg at approximately 7 PM or with supper (Q7PM) and QHS (for a total of 1,350 mg/day on the first 2 days), followed by a daily dose of 1,125 mg/day at Q7PM for 26 days and a taper over 4 days
|
|---|---|---|---|---|
|
Number of Participants With Clinical Global Impression-Improvement
Day 8/10 - Much Improved
|
1 Participants
|
5 Participants
|
7 Participants
|
14 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement
Day 8/10 - Minimally Improved
|
0 Participants
|
2 Participants
|
8 Participants
|
11 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement
Day 29 - Very much Improved
|
—
|
—
|
4 Participants
|
11 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement
Day 36/38 - Very much Improved
|
0 Participants
|
1 Participants
|
8 Participants
|
12 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement
Day 36/38 - Much Improved
|
2 Participants
|
3 Participants
|
4 Participants
|
10 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement
Day 89 - Very much Improved
|
—
|
—
|
6 Participants
|
—
|
|
Number of Participants With Clinical Global Impression-Improvement
Day 2/4 - Much Improved
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement
Day 2/4 - Minimally Improved
|
1 Participants
|
6 Participants
|
4 Participants
|
15 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement
Day 7 - Very much Improved
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Clinical Global Impression-Improvement
Day 7 - Much Improved
|
1 Participants
|
5 Participants
|
—
|
—
|
|
Number of Participants With Clinical Global Impression-Improvement
Day 7 - Minimally Improved
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Clinical Global Impression-Improvement
Day 8/10 - Very much Improved
|
0 Participants
|
2 Participants
|
—
|
3 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement
Day 15/17 - Very much Improved
|
0 Participants
|
2 Participants
|
1 Participants
|
6 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement
Day 15/17 - Much Improved
|
2 Participants
|
5 Participants
|
9 Participants
|
15 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement
Day 15/17 - Minimally Improved
|
0 Participants
|
3 Participants
|
5 Participants
|
9 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement
Day 22 - Very much Improved
|
—
|
—
|
1 Participants
|
7 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement
Day 22 - Much Improved
|
—
|
—
|
9 Participants
|
16 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement
Day 22 - Minimally Improved
|
—
|
—
|
6 Participants
|
6 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement
Day 29 - Much Improved
|
—
|
—
|
7 Participants
|
16 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement
Day 29 - Minimally Improved
|
—
|
—
|
8 Participants
|
5 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement
Day 36/38 - Minimally Improved
|
0 Participants
|
1 Participants
|
7 Participants
|
10 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement
Day 57/59 - Very Much Improved
|
—
|
—
|
4 Participants
|
9 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement
Day 57/59 - Much Improved
|
—
|
—
|
9 Participants
|
14 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement
Day 57/59 - Minimally Improved
|
—
|
—
|
2 Participants
|
7 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement
Day 71 - Very Much Improved
|
—
|
—
|
—
|
8 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement
Day 71 - Much Improved
|
—
|
—
|
—
|
14 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement
Day 71 - Minimally Improved
|
—
|
—
|
—
|
6 Participants
|
|
Number of Participants With Clinical Global Impression-Improvement
Day 89 - Much Improved
|
—
|
—
|
4 Participants
|
—
|
|
Number of Participants With Clinical Global Impression-Improvement
Day 89 - Minimally Improved
|
—
|
—
|
6 Participants
|
—
|
|
Number of Participants With Clinical Global Impression-Improvement
Day 119 - Very Much Improved
|
—
|
—
|
5 Participants
|
—
|
|
Number of Participants With Clinical Global Impression-Improvement
Day 119 - Much Improved
|
—
|
—
|
3 Participants
|
—
|
|
Number of Participants With Clinical Global Impression-Improvement
Day 119 - Minimally Improved
|
—
|
—
|
3 Participants
|
—
|
Adverse Events
TID (2-week)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
QHS (2-week)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
QHS (4-week)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
1125 mg (4-week)
Serious events: 1 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TID (2-week)
n=2 participants at risk
Oral ganaxolone doses were titrated to a daily dose of 900 mg/day Oral ganaxolone doses were titrated to a daily dose of 675 mg/day QHS over 4 days, which was maintained until Day 10, followed by a taper over 4 days
|
QHS (2-week)
n=14 participants at risk
Oral ganaxolone doses were titrated to a daily dose of 675 mg/day QHS over 4 days, which was maintained until Day 10, followed by a taper over 4 days
|
QHS (4-week)
n=25 participants at risk
Oral ganaxolone was dosed at a daily dose of 675 mg/day QHS for 28 days, followed by a taper over 4 days
|
1125 mg (4-week)
n=43 participants at risk
Oral ganaxolone was dosed as 675 mg at approximately 7 PM or with supper (Q7PM) and QHS (for a total of 1,350 mg/day on the first 2 days), followed by a daily dose of 1,125 mg/day at Q7PM for 26 days and a taper over 4 days
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/2 • Baseline up through Day 119
|
0.00%
0/14 • Baseline up through Day 119
|
0.00%
0/25 • Baseline up through Day 119
|
2.3%
1/43 • Number of events 1 • Baseline up through Day 119
|
Other adverse events
| Measure |
TID (2-week)
n=2 participants at risk
Oral ganaxolone doses were titrated to a daily dose of 900 mg/day Oral ganaxolone doses were titrated to a daily dose of 675 mg/day QHS over 4 days, which was maintained until Day 10, followed by a taper over 4 days
|
QHS (2-week)
n=14 participants at risk
Oral ganaxolone doses were titrated to a daily dose of 675 mg/day QHS over 4 days, which was maintained until Day 10, followed by a taper over 4 days
|
QHS (4-week)
n=25 participants at risk
Oral ganaxolone was dosed at a daily dose of 675 mg/day QHS for 28 days, followed by a taper over 4 days
|
1125 mg (4-week)
n=43 participants at risk
Oral ganaxolone was dosed as 675 mg at approximately 7 PM or with supper (Q7PM) and QHS (for a total of 1,350 mg/day on the first 2 days), followed by a daily dose of 1,125 mg/day at Q7PM for 26 days and a taper over 4 days
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/2 • Baseline up through Day 119
|
0.00%
0/14 • Baseline up through Day 119
|
0.00%
0/25 • Baseline up through Day 119
|
4.7%
2/43 • Baseline up through Day 119
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/2 • Baseline up through Day 119
|
7.1%
1/14 • Baseline up through Day 119
|
4.0%
1/25 • Baseline up through Day 119
|
4.7%
2/43 • Baseline up through Day 119
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Baseline up through Day 119
|
0.00%
0/14 • Baseline up through Day 119
|
8.0%
2/25 • Baseline up through Day 119
|
11.6%
5/43 • Baseline up through Day 119
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • Baseline up through Day 119
|
0.00%
0/14 • Baseline up through Day 119
|
0.00%
0/25 • Baseline up through Day 119
|
4.7%
2/43 • Baseline up through Day 119
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/2 • Baseline up through Day 119
|
0.00%
0/14 • Baseline up through Day 119
|
0.00%
0/25 • Baseline up through Day 119
|
4.7%
2/43 • Baseline up through Day 119
|
|
Nervous system disorders
Dizziness
|
50.0%
1/2 • Baseline up through Day 119
|
7.1%
1/14 • Baseline up through Day 119
|
8.0%
2/25 • Baseline up through Day 119
|
16.3%
7/43 • Baseline up through Day 119
|
|
Nervous system disorders
Headache
|
50.0%
1/2 • Baseline up through Day 119
|
7.1%
1/14 • Baseline up through Day 119
|
16.0%
4/25 • Baseline up through Day 119
|
25.6%
11/43 • Baseline up through Day 119
|
|
Nervous system disorders
Sedation
|
100.0%
2/2 • Baseline up through Day 119
|
14.3%
2/14 • Baseline up through Day 119
|
12.0%
3/25 • Baseline up through Day 119
|
16.3%
7/43 • Baseline up through Day 119
|
|
Nervous system disorders
Somnolence
|
0.00%
0/2 • Baseline up through Day 119
|
0.00%
0/14 • Baseline up through Day 119
|
16.0%
4/25 • Baseline up through Day 119
|
20.9%
9/43 • Baseline up through Day 119
|
|
Nervous system disorders
Tremor
|
0.00%
0/2 • Baseline up through Day 119
|
0.00%
0/14 • Baseline up through Day 119
|
0.00%
0/25 • Baseline up through Day 119
|
4.7%
2/43 • Baseline up through Day 119
|
|
Psychiatric disorders
Irritability
|
0.00%
0/2 • Baseline up through Day 119
|
0.00%
0/14 • Baseline up through Day 119
|
4.0%
1/25 • Baseline up through Day 119
|
4.7%
2/43 • Baseline up through Day 119
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/2 • Baseline up through Day 119
|
0.00%
0/14 • Baseline up through Day 119
|
0.00%
0/25 • Baseline up through Day 119
|
4.7%
2/43 • Baseline up through Day 119
|
|
Vascular disorders
Hot flush
|
0.00%
0/2 • Baseline up through Day 119
|
7.1%
1/14 • Baseline up through Day 119
|
4.0%
1/25 • Baseline up through Day 119
|
4.7%
2/43 • Baseline up through Day 119
|
Additional Information
Marinus Clinical Trials Submission Manager
Marinus Pharmaceuticals, Inc.
Phone: 484-801-4670
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place