Trial · NCT03460756
A Clinical Trial of Oral Ganaxolone in Women With Postpartum Depression
NCT03460756, Phase 2, Completed, Marinus Pharmaceuticals; results first posted 2023-01-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Clinical Trial of Oral Ganaxolone in Women With Postpartum Depression. Trials, record NCT03460756. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03460756
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Trial of Oral Ganaxolone in Women With Postpartum Depression
- NCT number
- NCT03460756
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 84 participants, actual
- Lead sponsor
- Marinus Pharmaceuticals
- Conditions
- Depressive Disorder, Depression, Depression, Postpartum, Behavioral Symptoms, Mood Disorders, Mental Disorder, Pregnancy Complications, Postpartum Blues, PPD, Postpartum Disorder
- Interventions
- Ganaxolone, Placebo
- First posted
- 2018-03-09
- Last updated
- 2023-08-18
- Results first posted
- 2023-01-30
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) Through Treatment | Baseline (Day 1) and through Day 10 for 2 week treatment group and Day 29 for 4 week treatment groups | 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. |
| Secondary | Change From Baseline in Hamilton Depression Rating Scale 17-item Version Post Treatment | Baseline (Day 1) and Through Day 38 for 2 week treatment group and Day 71 and 119 for 4 week treatment groups | 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. |
| Secondary | Number of Participants With Response to Hamilton Depression Rating Scale 17 Item (HAMD17) | 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) | 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. |
| Secondary | Number of Participants With Hamilton Depression Rating Scale 17-item Remission | 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) | 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. |
| Secondary | Change From Baseline in Edinburgh Postnatal Depression Scale (EPDS) Total Score | Baseline (Day 1) through Day 119 | 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. |
| Secondary | Change From Baseline in Spielberger State-Trait Anxiety Inventory, 6-item Version | Baseline (Day 1) through Day 119 | 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. |
| Secondary | Number of Participants With Clinical Global Impression-Improvement | Baseline through Day 119 | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) Through Treatment | Baseline (Day 1) and through Day 10 for 2 week treatment group and Day 29 for 4 week treatment groups | Safety Set was defined as all participants who were dispensed study drug. Only those participants with HAMD17 response through treatment have been presented. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Hamilton Depression Rating Scale 17-item Version Post Treatment | Baseline (Day 1) and Through Day 38 for 2 week treatment group and Day 71 and 119 for 4 week treatment groups | Safety Set. Only those participants with HAMD17 response post treatment have been presented. | score on a scale | MEAN |
| SECONDARY | Number of Participants With Response to Hamilton Depression Rating Scale 17 Item (HAMD17) | 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) | Safety Set. Only those participants with data available at specified timepoints have been presented. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Hamilton Depression Rating Scale 17-item Remission | 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) | Safety Set. Only those participants with data available at specified timepoints have been presented. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Edinburgh Postnatal Depression Scale (EPDS) Total Score | Baseline (Day 1) through Day 119 | Safety Set. Only those participants with data available at specified timepoints has been presented. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in Spielberger State-Trait Anxiety Inventory, 6-item Version | Baseline (Day 1) through Day 119 | Safety Set. Only those participants with data available at specified timepoints has been analyzed. | Scores on a scale | MEAN |
| SECONDARY | Number of Participants With Clinical Global Impression-Improvement | Baseline through Day 119 | Safety Set. Only those participants with data available at specified timepoints has been presented. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group206
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) Through Treatment | TID (2-week) | Day 2/4 | -8.0 | Standard Deviation 9.90 | score on a scale |
| Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) Through Treatment | QHS (2-week) | Day 2/4 | -5.7 | Standard Deviation 4.87 | score on a scale |
| Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) Through Treatment | QHS (4-week) | Day 2/4 | -0.8 | Standard Deviation 3.19 | score on a scale |
| Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) Through Treatment | 1125 mg (4-week) | Day 2/4 | -2.6 | Standard Deviation 5.46 | score on a scale |
| Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) Through Treatment | TID (2-week) | Day 7 | -15.0 | Standard Deviation 12.73 | score on a scale |
| Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) Through Treatment | QHS (2-week) | Day 7 | -6.7 | Standard Deviation 7.93 | score on a scale |
| Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) Through Treatment | TID (2-week) | Day 8/10 | -3.0 | Standard Deviation 0 | score on a scale |
| Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) Through Treatment | QHS (2-week) | Day 8/10 | -10.5 | Standard Deviation 7.21 | score on a scale |
| Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) Through Treatment | QHS (4-week) | Day 8/10 | -6.8 | Standard Deviation 7.25 | score on a scale |
| Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) Through Treatment | 1125 mg (4-week) | Day 8/10 | -10.2 | Standard Deviation 7.44 | score on a scale |
1 to 10 of 206Source ClinicalTrials.gov
See all 206 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TID (2-week) | 2 | |
| Overall Study | STARTED | QHS (2-week) | 14 | |
| Overall Study | STARTED | QHS (4-week) | 25 | |
| Overall Study | STARTED | 1125 mg (4-week) | 43 | |
| Overall Study | COMPLETED | TID (2-week) | 2 | |
| Overall Study | COMPLETED | QHS (2-week) | 9 | |
| Overall Study | COMPLETED | QHS (4-week) | 16 | |
| Overall Study | COMPLETED | 1125 mg (4-week) | 34 | |
| Overall Study | NOT COMPLETED | TID (2-week) | 0 | |
| Overall Study | NOT COMPLETED | QHS (2-week) | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events56
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vertigo | Ear and labyrinth disorders | TID (2-week) | 0 | 2 | |
| other | Vertigo | Ear and labyrinth disorders | QHS (2-week) | 0 | 14 | |
| other | Vertigo | Ear and labyrinth disorders | QHS (4-week) | 0 | 25 | |
| other | Vertigo | Ear and labyrinth disorders | 1125 mg (4-week) | 2 | 43 | |
| other | Dry mouth | Gastrointestinal disorders | TID (2-week) | 0 | 2 | |
| other | Dry mouth | Gastrointestinal disorders | QHS (2-week) | 1 | 14 | |
| other | Dry mouth | Gastrointestinal disorders | QHS (4-week) | 1 | 25 | |
| other | Dry mouth | Gastrointestinal disorders | 1125 mg (4-week) | 2 | 43 | |
| other | Nausea | Gastrointestinal disorders | TID (2-week) | 1 | 2 | |
| other | Nausea | Gastrointestinal disorders | QHS (2-week) | 0 | 14 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TID (2-week) | 0 | 2 |
| Total, all-cause mortality | QHS (2-week) | 0 | 14 |
| Total, all-cause mortality | QHS (4-week) | 0 | 25 |
| Total, all-cause mortality | 1125 mg (4-week) | 0 | 43 |
| Total, other adverse events | TID (2-week) | 2 | 2 |
| Total, other adverse events | QHS (2-week) | 5 | 14 |
| Total, other adverse events | QHS (4-week) | 16 | 25 |
| Total, other adverse events | 1125 mg (4-week) | 32 | 43 |
| Total, serious adverse events | TID (2-week) | 0 | 2 |
| Total, serious adverse events | QHS (2-week) | 0 | 14 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03460756
GET https://conductscience.org/api/trials/v1/NCT03460756/results?page=2