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A clinical study to evaluate safety, tolerability and efficacy of oral administration of ganaxolone in women with postpartum depression
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ganaxolone | Experimental | Oral |
|
| Placebo | Placebo Comparator | Oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ganaxolone | Drug | Oral |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) Through Treatment | 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. | Baseline (Day 1) and through Day 10 for 2 week treatment group and Day 29 for 4 week treatment groups |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hamilton Depression Rating Scale 17-item Version Post Treatment | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Women with postpartum depression
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Hulihan, MD | Marinus Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marinus Research Site | Glendale | California | 91206 | United States | ||
| Marinus Research Site |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | QHS (2-week) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 22, 2018 | Aug 2, 2023 |
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| Drug |
Oral |
|
| Baseline (Day 1) and Through Day 38 for 2 week treatment group and Day 71 and 119 for 4 week treatment groups |
| Number of Participants With Response to Hamilton Depression Rating Scale 17 Item (HAMD17) | 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. | 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) |
| Number of Participants With Hamilton Depression Rating Scale 17-item Remission | 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. | 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) |
| Change From Baseline in Edinburgh Postnatal Depression Scale (EPDS) Total Score | 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. | Baseline (Day 1) through Day 119 |
| Change From Baseline in Spielberger State-Trait Anxiety Inventory, 6-item Version | 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. | Baseline (Day 1) through Day 119 |
| Number of Participants With Clinical Global Impression-Improvement | 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. | Baseline through Day 119 |
| Lemon Grove |
| California |
| 91945 |
| United States |
| Marinus Research Site | Long Beach | California | 90806 | United States |
| Marinus Research Site | Oceanside | California | 92056 | United States |
| Marinus Research Site | Panorama City | California | 91402 | United States |
| Marinus Research Site | San Bernardino | California | 92408 | United States |
| Marinus Research Site | San Marcos | California | 92078 | United States |
| Marinus Research Site | Ventura | California | 93003 | United States |
| Marinus Research Site | Gainesville | Florida | 32607 | United States |
| Marinus Research Site | Hollywood | Florida | 33021 | United States |
| Marinus Research Site | Jacksonville | Florida | 32216 | United States |
| Marinus Research Site | North Miami | Florida | 33161 | United States |
| Marinus Research Site | Atlanta | Georgia | 30328 | United States |
| Marinus Research Site | Atlanta | Georgia | 30331 | United States |
| Marinus Research Site | Decatur | Georgia | 30030 | United States |
| Marinus Research Site | Marietta | Georgia | 30060 | United States |
| Marinus Research Site | Idaho Falls | Idaho | 83404 | United States |
| Marinus Research Site | Hoffman Estates | Illinois | 60169 | United States |
| Marinus Research Site | Leawood | Kansas | 66206 | United States |
| Marinus Research Site | Wichita | Kansas | 67226 | United States |
| Marinus Research Site | Flowood | Mississippi | 39232 | United States |
| Marinus Research Site | Las Vegas | Nevada | 89102 | United States |
| Marinus Research Site | Albuquerque | New Mexico | 87102 | United States |
| Marinus Research Site | Raleigh | North Carolina | 27612 | United States |
| Marinus Research Site | Englewood | Ohio | 45322 | United States |
| Marinus Research Site | Downingtown | Pennsylvania | 19335 | United States |
| Marinus Research Site | Media | Pennsylvania | 19063 | United States |
| Marinus Research Site | Houston | Texas | 77058 | United States |
| Marinus Research Site | Irving | Texas | 75062 | United States |
| Marinus Research Site | League City | Texas | 77573 | United States |
| Marinus Research Site | San Antonio | Texas | 78229 | United States |
| Marinus Research Site | Orem | Utah | 84058-4939 | United States |
| Marinus Research Site | Richmond | Virginia | 23298 | United States |
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
| FG002 | 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. |
| FG003 | 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 |
| COMPLETED | 2-week TID group was discontinued after 2 subjects were enrolled due to daytime TEAE of sedation and dizziness |
|
| NOT COMPLETED |
|
|
Safety Set
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | TID (2-week) | 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 |
| BG001 | QHS (2-week) | 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 |
| BG002 | QHS (4-week) | Oral ganaxolone was dosed at a daily dose of 675 mg/day QHS for 28 days, followed by a taper over 4 days |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) Through Treatment | 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. | Safety Set was defined as all participants who were dispensed study drug. Only those participants with HAMD17 response through treatment have been presented. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 1) and through Day 10 for 2 week treatment group and Day 29 for 4 week treatment groups |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Hamilton Depression Rating Scale 17-item Version Post Treatment | 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. | Safety Set. Only those participants with HAMD17 response post treatment have been presented. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 1) and Through Day 38 for 2 week treatment group and Day 71 and 119 for 4 week treatment groups |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Response to Hamilton Depression Rating Scale 17 Item (HAMD17) | 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. | Safety Set. Only those participants with data available at specified timepoints have been presented. | Posted | Count of Participants | Participants | 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) |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Hamilton Depression Rating Scale 17-item Remission | 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. | Safety Set. Only those participants with data available at specified timepoints have been presented. | Posted | Count of Participants | Participants | 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) |
| ||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Edinburgh Postnatal Depression Scale (EPDS) Total Score | 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. | Safety Set. Only those participants with data available at specified timepoints has been presented. | Posted | Mean | Standard Error | Score on a scale | Baseline (Day 1) through Day 119 |
| |||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Spielberger State-Trait Anxiety Inventory, 6-item Version | 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. | Safety Set. Only those participants with data available at specified timepoints has been analyzed. | Posted | Mean | Standard Error | Scores on a scale | Baseline (Day 1) through Day 119 |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinical Global Impression-Improvement | 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. | Safety Set. Only those participants with data available at specified timepoints has been presented. | Posted | Count of Participants | Participants | Baseline through Day 119 |
|
Baseline up through Day 119
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TID (2-week) | 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 | 0 | 2 | 0 | 2 | 2 | 2 |
| EG001 | QHS (2-week) | 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 | 0 | 14 | 0 | 14 | 5 | 14 |
| EG002 | QHS (4-week) | Oral ganaxolone was dosed at a daily dose of 675 mg/day QHS for 28 days, followed by a taper over 4 days | 0 | 25 | 0 | 25 | 16 | 25 |
| EG003 | 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 | 0 | 43 | 1 | 43 | 32 | 43 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marinus Clinical Trials Submission Manager | Marinus Pharmaceuticals, Inc. | 484-801-4670 | clinicaltrials@marinuspharma.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 15, 2018 | Aug 2, 2023 | SAP_003.pdf |
Not provided
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D003863 | Depression |
| D019052 | Depression, Postpartum |
| D001526 | Behavioral Symptoms |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D011248 | Pregnancy Complications |
| D011644 | Puerperal Disorders |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C105051 | ganaxolone |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Day 7 |
|
|
| Day 8/10 |
|
|
| Day 15/17 |
|
|
| Day 22 |
|
|
| Day 29 |
|
|
| OG002 | 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. |
| OG003 | 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 |
|
|
| OG001 | QHS (2-week) | 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 |
| OG002 | 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. |
| OG003 | 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 |
|
|
| QHS (2-week) |
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 |
| OG002 | 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. |
| OG003 | 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 |
|
|
| OG002 | 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 |
| OG003 | 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 |
|
|
| OG002 | 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. |
| OG003 | 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 |
|
|
| OG003 | 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 |
|
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