Trial · NCT03228394
A Clinical Trial of Intravenous (IV) Ganaxolone in Women With Postpartum Depression
NCT03228394, Phase 2, Completed, Marinus Pharmaceuticals; results first posted 2023-02-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Clinical Trial of Intravenous (IV) Ganaxolone in Women With Postpartum Depression. Trials, record NCT03228394. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03228394
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Trial of Intravenous (IV) Ganaxolone in Women With Postpartum Depression
- NCT number
- NCT03228394
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 91 participants, actual
- Lead sponsor
- Marinus Pharmaceuticals
- Conditions
- Depression, Depressive Disorder, Depression, Postpartum, Behavioral Symptoms, Mood Disorders, Mental Disorders, Puerperal Disorders, Pregnancy Complications, Postpartum, PPD
- Interventions
- Ganaxolone, Placebo
- First posted
- 2017-07-24
- Last updated
- 2023-07-19
- Results first posted
- 2023-02-08
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) Total Score | Baseline and Day 3 post-infusion (60 hours post start of infusion) for Cohorts 1 to 3 and Baseline and Day 29 for Cohort 6 | 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 was calculated by subtracting Baseline value from the post-dose visit value. |
| Secondary | Change From Baseline in HAMD17 Total Score at Indicated Time Points | Baseline, Day1 post-infusion(6hours post start of infusion), Day1(12hours post start of infusion), Day2(24hours post start of infusion),Day3 post-infusion(48hours post start of infusion),Day4(72hours post start of infusion),Days 8,11,15,22,36,57 and 71 | 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 was calculated by subtracting Baseline value from the post-dose visit value. |
| Secondary | Number of Participants With HAMD17 Response | Day1 post-infusion (6 hours post start of infusion [SOI]), Day 1 (12 hours post SOI), Day 2 (24 hours post SOI),Day 3 post-infusion (48 hours post SOI), Day 3 post-infusion (60 hours post SOI), Day 4 (72 hours post SOI), Days 8,11,15,22,29,36,57 and 71 | HAMD17 Response was defined as ≥50% reduction from Baseline in total score. 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. Number of participants with HAMD17 response is presented. |
| Secondary | Number of Participants With HAMD17 Remission | Day1 post-infusion (6 hours post start of infusion [SOI]), Day 1 (12 hours post SOI), Day2 (24 hours post SOI), Day 3 post-infusion (48 hours post SOI), Day 3 post-infusion (60 hours post SOI), Day 4 (72 hours post SOI), Days 8,11,15,22,29,34,57 and 71 | HAMD17 Remission was defined as total score ≤7. 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. Number of participants with HAMD17 remission is presented |
| Secondary | Change From Baseline in Edinburgh Postnatal Depression Scale (EPDS) Total Score | Baseline, Day 1, Day 2, Day 3 post-infusion (60 hours post start of infusion), Day 8, Day 11, Day 15, Day 22, Day 29, Day 34, Day 36, Day 57 and Day 71 | 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 was calculated by subtracting Baseline value from the post-dose visit value. |
| Secondary | Change From Baseline in Spielberger State-Trait Anxiety Inventory 6-item Version (STAI6) Total Score | Baseline, Day 1 (12 hours post start of infusion), Day 2, Day 3 post-infusion (60 hours post start of infusion), Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 34, Day 36, Day 57 and Day 71 | The STAI6 is a 6-item self-rated instrument used to assess anxiety state. The STAI6 questions included: 1. "I feel calm"; 2. "I am tense"; 3. "I feel upset"; 4. "I am relaxed"; 5. "I feel content"; 6. "I am worried". Each of these questions were rated as: a) "not at all"; b) "somewhat"; c) "moderately"; d) "very much". For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4. For the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1. The STAI6 score was the result of first totaling the 6 individual item scores, and then prorating by a multiplication factor of 20/6 to acquire a score range of 20 (low anxiety) to 80 (high anxiety). Higher score indicated higher level of anxiety. Baseline was defined as the Day 1 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Secondary | Number of Participants With Response to Clinical Global Impression-Improvement (CGI-I) Scale | Day 1 (12 hours post start of infusion), Day 2, Day 3 post-infusion (60 hours post start of infusion), Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 34, Day 36, Day 57 and Day 71 | 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. Response was defined as \>50% decrease from Baseline in CGI-I total score. |
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) Total Score | Baseline and Day 3 post-infusion (60 hours post start of infusion) for Cohorts 1 to 3 and Baseline and Day 29 for Cohort 6 | Modified intent-to-treat (mITT) population: Included all participants in the safety set who had ≥1 post-randomization efficacy assessment. Only those participants with data available at the specified data points were analyzed. | Scores on a scale | MEAN |
| SECONDARY | Change From Baseline in HAMD17 Total Score at Indicated Time Points | Baseline, Day1 post-infusion(6hours post start of infusion), Day1(12hours post start of infusion), Day2(24hours post start of infusion),Day3 post-infusion(48hours post start of infusion),Day4(72hours post start of infusion),Days 8,11,15,22,36,57 and 71 | mITT population. Only those participants with data available at the specified data points were analyzed. | Scores on a scale | MEAN |
| SECONDARY | Number of Participants With HAMD17 Response | Day1 post-infusion (6 hours post start of infusion [SOI]), Day 1 (12 hours post SOI), Day 2 (24 hours post SOI),Day 3 post-infusion (48 hours post SOI), Day 3 post-infusion (60 hours post SOI), Day 4 (72 hours post SOI), Days 8,11,15,22,29,36,57 and 71 | mITT population. Only those participants with data available at the specified data points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With HAMD17 Remission | Day1 post-infusion (6 hours post start of infusion [SOI]), Day 1 (12 hours post SOI), Day2 (24 hours post SOI), Day 3 post-infusion (48 hours post SOI), Day 3 post-infusion (60 hours post SOI), Day 4 (72 hours post SOI), Days 8,11,15,22,29,34,57 and 71 | mITT population. Only those participants with data available at the specified data points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Edinburgh Postnatal Depression Scale (EPDS) Total Score | Baseline, Day 1, Day 2, Day 3 post-infusion (60 hours post start of infusion), Day 8, Day 11, Day 15, Day 22, Day 29, Day 34, Day 36, Day 57 and Day 71 | mITT population. Only those participants with data available at the specified data points were analyzed. | Scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Spielberger State-Trait Anxiety Inventory 6-item Version (STAI6) Total Score | Baseline, Day 1 (12 hours post start of infusion), Day 2, Day 3 post-infusion (60 hours post start of infusion), Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 34, Day 36, Day 57 and Day 71 | mITT population. Only those participants with data available at the specified data points were analyzed. | Scores on a scale | MEAN |
| SECONDARY | Number of Participants With Response to Clinical Global Impression-Improvement (CGI-I) Scale | Day 1 (12 hours post start of infusion), Day 2, Day 3 post-infusion (60 hours post start of infusion), Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 34, Day 36, Day 57 and Day 71 | mITT population. Only those participants with data available at the specified data points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group390
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) Total Score | Placebo Cohort 1 | Day 3 post-infusion (60 hours post start of infusion) | -13.0 | Standard Deviation 10.10 | Scores on a scale |
| Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) Total Score | Ganaxolone Cohort 1 | Day 3 post-infusion (60 hours post start of infusion) | -12.0 | Standard Deviation 6.82 | Scores on a scale |
| Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) Total Score | Placebo Cohort 2 | Day 3 post-infusion (60 hours post start of infusion) | -14.0 | Standard Deviation 9.10 | Scores on a scale |
| Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) Total Score | Ganaxolone Cohort 2 | Day 3 post-infusion (60 hours post start of infusion) | -14.3 | Standard Deviation 10.23 | Scores on a scale |
| Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) Total Score | Placebo Cohort 3 | Day 3 post-infusion (60 hours post start of infusion) | -11.0 | Standard Deviation 6.58 | Scores on a scale |
| Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) Total Score | Ganaxolone Cohort 3 | Day 3 post-infusion (60 hours post start of infusion) | -11.3 | Standard Deviation 7.04 | Scores on a scale |
| Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) Total Score | Placebo Cohort 6 | Day 29 | -13.6 | Standard Deviation 11.51 | Scores on a scale |
| Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) Total Score | Ganaxolone Cohort 6 | Day 29 | -11.5 | Standard Deviation 11.43 | Scores on a scale |
| Change From Baseline in HAMD17 Total Score at Indicated Time Points | Placebo Cohort 6 | Day 1 post-infusion (6 hours post start of infusion) | -3.2 | Standard Deviation 6.85 | Scores on a scale |
| Change From Baseline in HAMD17 Total Score at Indicated Time Points | Ganaxolone Cohort 6 | Day 1 post-infusion (6 hours post start of infusion) | -6.1 | Standard Deviation 9.97 | Scores on a scale |
1 to 10 of 390Source ClinicalTrials.gov
See all 390 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo Cohort 1 | 4 | |
| Overall Study | STARTED | Ganaxolone Cohort 1 | 5 | |
| Overall Study | STARTED | Placebo Cohort 2 | 14 | |
| Overall Study | STARTED | Ganaxolone Cohort 2 | 15 | |
| Overall Study | STARTED | Placebo Cohort 3 | 10 | |
| Overall Study | STARTED | Ganaxolone Cohort 3 | 10 | |
| Overall Study | STARTED | Placebo Cohort 6 | 17 | |
| Overall Study | STARTED | Ganaxolone Cohort 6 | 16 | |
| Overall Study | COMPLETED | Placebo Cohort 1 | 4 | |
| Overall Study | COMPLETED | Ganaxolone Cohort 1 | 5 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events400
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 | Ear Pain | Ear and labyrinth disorders | Placebo Cohort 1 | 0 | 4 | 0 |
| other | Ear Pain | Ear and labyrinth disorders | Ganaxolone Cohort 1 | 0 | 5 | 0 |
| other | Ear Pain | Ear and labyrinth disorders | Placebo Cohort 2 | 1 | 14 | 1 |
| other | Ear Pain | Ear and labyrinth disorders | Ganaxolone Cohort 2 | 0 | 15 | 0 |
| other | Ear Pain | Ear and labyrinth disorders | Placebo Cohort 3 | 0 | 10 | 0 |
| other | Ear Pain | Ear and labyrinth disorders | Ganaxolone Cohort 3 | 0 | 10 | 0 |
| other | Ear Pain | Ear and labyrinth disorders | Placebo Cohort 6 | 0 | 17 | 0 |
| other | Ear Pain | Ear and labyrinth disorders | Ganaxolone Cohort 6 | 0 | 16 | 0 |
| other | Hypothyroidism | Endocrine disorders | Placebo Cohort 1 | 0 | 4 | 0 |
| other | Hypothyroidism | Endocrine disorders | Ganaxolone Cohort 1 | 0 | 5 | 0 |
1 to 10 of 400Source ClinicalTrials.gov
See all 400 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Cohort 1 | 0 | 4 |
| Total, all-cause mortality | Ganaxolone Cohort 1 | 0 | 5 |
| Total, all-cause mortality | Placebo Cohort 2 | 0 | 14 |
| Total, all-cause mortality | Ganaxolone Cohort 2 | 0 | 15 |
| Total, all-cause mortality | Placebo Cohort 3 | 0 | 10 |
| Total, all-cause mortality | Ganaxolone Cohort 3 | 0 | 10 |
| Total, all-cause mortality | Placebo Cohort 6 | 0 | 17 |
| Total, all-cause mortality | Ganaxolone Cohort 6 | 0 | 16 |
| Total, other adverse events | Placebo Cohort 1 | 1 | 4 |
| Total, other adverse events | Ganaxolone Cohort 1 | 2 | 5 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03228394
GET https://conductscience.org/api/trials/v1/NCT03228394/results?page=2