A Clinical Trial of Oral Ganaxolone in Women With Postpartum Depression

NCT03460756 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 1042-PPD-2003
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 33

Brief Summary

A clinical study to evaluate safety, tolerability and efficacy of oral administration of ganaxolone in women with postpartum depression

Conditions

Depressive Disorder; Depression; Depression, Postpartum; Behavioral Symptoms; Mood Disorders; Mental Disorder; Pregnancy Complications; Postpartum Blues; PPD; Postpartum Disorder

Keywords

Postpartum Care; Postpartum Depression

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• 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

• 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)

• 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)

• Change From Baseline in Edinburgh Postnatal Depression Scale (EPDS) Total Score

  Baseline (Day 1) through Day 119

• Change From Baseline in Spielberger State-Trait Anxiety Inventory, 6-item Version

  Baseline (Day 1) through Day 119

Study Arms (2)

Ganaxolone

EXPERIMENTAL

Oral

Drug: Ganaxolone

Placebo

PLACEBO COMPARATOR

Oral

Drug: Placebo

Interventions

Ganaxolone DRUG

Oral

Ganaxolone

Placebo DRUG

Oral

Placebo

Eligibility Criteria

• Age: 18 Years - 48 Years
• Gender Eligibility Details: Women with postpartum depression
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Experiencing 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
• Given birth in the last 6 months
• HAMD17 score of ≥ 20 at screening but \< 26
• 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 history of any psychotic illness, including major depressive episode with psychotic features
• History of suicide attempt within the past 3 years
• History of bipolar I disorder
• History of seizure discorder

Sponsors & Collaborators

• Marinus Pharmaceuticals: lead

Study Sites (33)

Marinus Research Site

Glendale, California, 91206, United States

Location

Marinus Research Site

Lemon Grove, California, 91945, United States

Location

Marinus Research Site

Long Beach, California, 90806, United States

Location

Marinus Research Site

Oceanside, California, 92056, United States

Location

Marinus Research Site

Panorama City, California, 91402, United States

Location

Marinus Research Site

San Bernardino, California, 92408, United States

Location

Marinus Research Site

San Marcos, California, 92078, United States

Location

Marinus Research Site

Ventura, California, 93003, United States

Location

Marinus Research Site

Gainesville, Florida, 32607, United States

Location

Marinus Research Site

Hollywood, Florida, 33021, United States

Location

Marinus Research Site

Jacksonville, Florida, 32216, United States

Location

Marinus Research Site

North Miami, Florida, 33161, United States

Location

Marinus Research Site

Atlanta, Georgia, 30328, United States

Location

Marinus Research Site

Atlanta, Georgia, 30331, United States

Location

Marinus Research Site

Decatur, Georgia, 30030, United States

Location

Marinus Research Site

Marietta, Georgia, 30060, United States

Location

Marinus Research Site

Idaho Falls, Idaho, 83404, United States

Location

Marinus Research Site

Hoffman Estates, Illinois, 60169, United States

Location

Marinus Research Site

Leawood, Kansas, 66206, United States

Location

Marinus Research Site

Wichita, Kansas, 67226, United States

Location

Marinus Research Site

Flowood, Mississippi, 39232, United States

Location

Marinus Research Site

Las Vegas, Nevada, 89102, United States

Location

Marinus Research Site

Albuquerque, New Mexico, 87102, United States

Location

Marinus Research Site

Raleigh, North Carolina, 27612, United States

Location

Marinus Research Site

Englewood, Ohio, 45322, United States

Location

Marinus Research Site

Downingtown, Pennsylvania, 19335, United States

Location

Marinus Research Site

Media, Pennsylvania, 19063, United States

Location

Marinus Research Site

Houston, Texas, 77058, United States

Location

Marinus Research Site

Irving, Texas, 75062, United States

Location

Marinus Research Site

League City, Texas, 77573, United States

Location

Marinus Research Site

San Antonio, Texas, 78229, United States

Location

Marinus Research Site

Orem, Utah, 84058-4939, United States

Location

Marinus Research Site

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Depressive Disorder; Depression; Depression, Postpartum; Behavioral Symptoms; Mood Disorders; Mental Disorders; Pregnancy Complications; Puerperal Disorders

Interventions

ganaxolone

Condition Hierarchy (Ancestors)

Behavior; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: Marinus Clinical Trials Submission Manager
• Organization: Marinus Pharmaceuticals, Inc.

clinicaltrials@marinuspharma.com

484-801-4670

Study Officials

• Joseph Hulihan, MD

  Marinus Pharmaceuticals

  STUDY DIRECTOR

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: January 18, 2018
• First Posted: March 9, 2018
• Study Start: December 28, 2017
• Primary Completion: July 5, 2019
• Study Completion: July 5, 2019
• Last Updated: August 18, 2023
• Results First Posted: January 30, 2023

Record last verified: 2023-08

Locations

US (33)