A Clinical Trial of Oral Ganaxolone in Women With Postpartum Depression

• Sponsor: Marinus Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03460756
• Collaborator: (none)
• Enrollment: 84
• Locations: 33
• Arms: 2
• Actual Duration (Months): 18.2
• Patients Per Site: 2.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Depressive Disorder; Depression; Depression, Postpartum; Behavioral Symptoms; Mood Disorders; Mental Disorder; Pregnancy Complications; Postpartum Blues; PPD; Postpartum Disorder	Drug: Ganaxolone; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 2, Double-blind, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability, and Efficacy of Oral Administration of Ganaxolone in Women With Postpartum Depression
• Actual Study Start Date: Dec 28, 2017
• Actual Primary Completion Date: Jul 5, 2019
• Actual Study Completion Date: Jul 5, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ganaxolone Oral	Drug: Ganaxolone; Oral
Placebo Comparator: Placebo Oral	Drug: Placebo; Oral

Outcome Measures

Primary Outcome Measures

1. Hamilton Depression Rating Scale [38 days]

   Efficacy of oral administered ganaxolone vs. placebo as assessed by change from baseline in the HAMD17 total score

2. Treatment-Emergent Adverse Events [38 days]

   Safety and tolerability of oral administered ganaxolone vs. placebo as assessed by the incidence of treatment-emergent adverse events

3. Clinical Laboratory Measures [17 days]

   Safety and tolerability of oral administered ganaxolone vs. placebo as assessed by change from baseline in laboratory measures (biochemistry, hematology and urinalysis) per group and number of individuals with potentially clinically significant abnormal values of laboratory assessments in each group.

4. Vital Signs - Blood Pressure [38 days]

   Safety and tolerability of oral administered ganaxolone vs. placebo as assessed by potentially clinically significant change from baseline in blood pressure (mm Hg)

5. Vital Signs - Pulse [38 Days]

   Safety and tolerability of oral administered ganaxolone vs. placebo as assessed by change from baseline in pulse (Beats per minute)

6. Vital Signs - Temperature [38 Days]

   Safety and tolerability of oral administered ganaxolone vs. placebo as assessed by change from baseline in temperature (C°)

7. Columbia Suicide Severity Rating Scale (CSSRS) [38 Days]

   Assessment of suicidal ideation or behavior by using the CSSRS scale.

8. Electrocardiogram (ECG) [10 Days]

   Change from baseline in ECG measures (e.g. heart rate, PR interval, QRS complex, QTcF) per group and number of individuals with potentially clinically significant abnormal values of ECG measures in each group.

9. Stanford Sleepiness Scale (SSS) [38 Days]

   Safety and tolerability of oral administered ganaxolone vs. placebo as assessed by change from baseline in SSS. This scale is measured from 1-7, with 7 being the highest degree of sleepiness.

10. Changes assessed by Physical Examination [10 days]

    Number of individuals with potentially significant physical exam findings per group.

Secondary Outcome Measures

1. Edinburgh Postnatal Depression Scale (EPDS) [38 days]

   Efficacy of oral administered ganaxolone vs. placebo as assessed by EPDS

2. Spielberger State-Trait Anxiety Inventory six item version (STA6) [38 days]

   Efficacy of oral administered ganaxolone vs. placebo as assessed by STA6

3. Clinical Global Impression-Improvement [38 days]

   Efficacy of oral administered ganaxolone vs. placebo as assessed by CGI-I

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 48 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marinus Research Site	Glendale	California	United States	91206
2	Marinus Research Site	Lemon Grove	California	United States	91945
3	Marinus Research Site	Long Beach	California	United States	90806
4	Marinus Research Site	Oceanside	California	United States	92056
5	Marinus Research Site	Panorama City	California	United States	91402
6	Marinus Research Site	San Bernardino	California	United States	92408
7	Marinus Research Site	San Marcos	California	United States	92078
8	Marinus Research Site	Ventura	California	United States	93003
9	Marinus Research Site	Gainesville	Florida	United States	32607
10	Marinus Research Site	Hollywood	Florida	United States	33021
11	Marinus Research Site	Jacksonville	Florida	United States	32216
12	Marinus Research Site	North Miami	Florida	United States	33161
13	Marinus Research Site	Atlanta	Georgia	United States	30328
14	Marinus Research Site	Atlanta	Georgia	United States	30331
15	Marinus Research Site	Decatur	Georgia	United States	30030
16	Marinus Research Site	Marietta	Georgia	United States	30060
17	Marinus Research Site	Idaho Falls	Idaho	United States	83404
18	Marinus Research Site	Hoffman Estates	Illinois	United States	60169
19	Marinus Research Site	Leawood	Kansas	United States	66206
20	Marinus Research Site	Wichita	Kansas	United States	67226
21	Marinus Research Site	Flowood	Mississippi	United States	39232
22	Marinus Research Site	Las Vegas	Nevada	United States	89102
23	Marinus Research Site	Albuquerque	New Mexico	United States	87102
24	Marinus Research Site	Raleigh	North Carolina	United States	27612
25	Marinus Research Site	Englewood	Ohio	United States	45322
26	Marinus Research Site	Downingtown	Pennsylvania	United States	19335
27	Marinus Research Site	Media	Pennsylvania	United States	19063
28	Marinus Research Site	Houston	Texas	United States	77058
29	Marinus Research Site	Irving	Texas	United States	75062
30	Marinus Research Site	League City	Texas	United States	77573
31	Marinus Research Site	San Antonio	Texas	United States	78229
32	Marinus Research Site	Orem	Utah	United States	84058-4939
33	Marinus Research Site	Richmond	Virginia	United States	23298

Sponsors and Collaborators

• Marinus Pharmaceuticals

Investigators

• Study Director: Joseph Hulihan, MD, Marinus Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marinus Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT03460756
• Other Study ID Numbers: 1042-PPD-2003
• First Posted: Mar 9, 2018
• Last Update Posted: Oct 22, 2020
• Last Verified: Oct 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Marinus Pharmaceuticals: Postpartum Care; Postpartum Depression
• Additional relevant MeSH terms: Depression, Postpartum; Pregnancy Complications; Puerperal Disorders; Disease; Depression; Depressive Disorder; Mental Disorders; Mood Disorders; Behavioral Symptoms; Ganaxolone

Study Results

No Results Posted as of Oct 22, 2020