NCT03228394

Brief Summary

This study will evaluate the Safety, Pharmacokinetics and Efficacy of IV Administration of Ganaxolone in Women with Postpartum Depression

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for phase_2 depression

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 27, 2017

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 24, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2020

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

February 8, 2023

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

1.9 years

First QC Date

July 5, 2017

Results QC Date

May 24, 2022

Last Update Submit

July 4, 2023

Conditions

DepressionDepressive DisorderDepression, PostpartumBehavioral SymptomsMood DisordersMental DisordersPuerperal DisordersPregnancy ComplicationsPostpartumPPD

Keywords

Postpartum CarePostpartum Depression

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) 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. 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.

    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

Secondary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Ganaxolone

EXPERIMENTAL

Intravenous

Drug: Ganaxolone

Placebo

PLACEBO COMPARATOR

Intravenous

Drug: Placebo

Interventions

GanaxoloneDRUG

Ganaxolone IV

Ganaxolone
PlaceboDRUG

Placebo IV

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen with postpartum depression
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Participant experienced a Major Depressive Episode, which started between the start of the third trimester and 4 weeks following delivery. The Major Depressive Episode must be diagnosed according to Mini International Neuropsychiatric Interview (MINI) 7.0 interview
  • Participant gave birth in the last 6 months
  • Participant has a Hamilton Depression Rating Scale 17-item version (HAMD17) score of ≥ 26 at screening
  • Participant must agree to stop breastfeeding from start of study treatment or must agree to temporarily cease giving breast milk to her infant(s)

You may not qualify if:

  • Current or past history of any psychotic illness, including Major Depressive Episode with psychotic features
  • History of suicide attempt within the past 3 years
  • Active suicidal ideation
  • History of bipolar I disorder
  • History of seizure disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Marinus Research Site

Little Rock, Arkansas, 72211, United States

Location

Marinus Research Site

Costa Mesa, California, 92626, United States

Location

Marinus Research Site

Lemon Grove, California, 91945, United States

Location

Marinus Research Site

San Diego, California, 92103, United States

Location

Marinus Research Site

Jacksonville, Florida, 32216, United States

Location

Marinus Research Site

Atlanta, Georgia, 30331, United States

Location

Marinus Research Site

Decatur, Georgia, 30030, United States

Location

Marinus Research Site

Leawood, Kansas, 66206, United States

Location

Marinus Research Site

Overland Park, Kansas, 66211, United States

Location

Marinus Research Site

New York, New York, 10032, United States

Location

Marinus Research Site

Dayton, Ohio, 45417, United States

Location

Marinus Research Site

Houston, Texas, 77058, United States

Location

Marinus Research Site

Irving, Texas, 75062, United States

Location

Marinus Research Site

Orem, Utah, 84058, United States

Location

Marinus Research Site

Salt Lake City, Utah, 84124, United States

Location

Marinus Research Site

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

DepressionDepressive DisorderDepression, PostpartumBehavioral SymptomsMood DisordersMental DisordersPuerperal DisordersPregnancy Complications

Interventions

ganaxolone

Condition Hierarchy (Ancestors)

BehaviorFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Results Point of Contact

Title
Marinus Clinical Trials Submission Manager
Organization
Marinus Pharmaceuticals, Inc.
clinicaltrials@marinuspharma.com
484-801-4670

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2017

First Posted

July 24, 2017

Study Start

June 27, 2017

Primary Completion

May 10, 2019

Study Completion

May 10, 2020

Last Updated

July 19, 2023

Results First Posted

February 8, 2023

Record last verified: 2023-07

Locations

US(16)