A Clinical Trial of Intravenous Ganaxolone in Women With Postpartum Depression

Sponsor

Marinus Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT03228394

Collaborator

(none)

Enrollment

Locations

Arms

34.4

Actual Duration (Months)

5.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

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

Detailed Description

This study will explore whether ganaxolone is safe and well tolerated in women suffering from PPD. In addition, ganaxolone's efficacy in treating depressive symptoms will be assessed through a set of exploratory analyses. Plasma levels of ganaxolone will be determined through pharmacokinetic analysis. The study results will be used to select a ganaxolone dose and dosing regimen for further development in PPD.

Study Design

Study Type:

Interventional

Actual Enrollment :

91 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Phase 2A, Double-blind, Placebo-controlled, Multiple-dose Escalation Study to Evaluate Safety, Pharmacokinetics and Efficacy of Intravenously Administered Ganaxolone in Women With Postpartum Depression

Actual Study Start Date :

Jun 27, 2017

Actual Primary Completion Date :

May 10, 2019

Actual Study Completion Date :

May 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ganaxolone Intravenous	Drug: Ganaxolone Ganaxolone IV
Placebo Comparator: Placebo Intravenous	Drug: Placebo Placebo IV

Arm

Intervention/Treatment

Experimental: Ganaxolone

Intravenous

Drug: Ganaxolone

Ganaxolone IV

Placebo Comparator: Placebo

Intravenous

Drug: Placebo

Placebo IV

Outcome Measures

Primary Outcome Measures

Treatment-Emergent Adverse Events [34 days]
Safety and tolerability of IV administered ganaxolone as assessed by the incidence of Treatment-Emergent Adverse Events
Clinical Laboratory Measures [11 days]
Safety and tolerability of IV administered ganaxolone as assessed by laboratory measures
Vital Signs [34 days]
Safety and tolerability of IV administered ganaxolone as assessed by vital signs
Columbia Suicide Severity Rating Scale (CSSRS) [34 days]
Safety and tolerability of IV administered ganaxolone as assessed by CSSRS
Electrocardiogram (ECG) [4 days]
Safety and tolerability of IV administered ganaxolone as assessed by ECG measurements
Stanford Sleepiness Scale (SSS) [4 days]
Safety and tolerability of IV administered ganaxolone as assessed by changes in SSS measurement
Physical Examination [4 days]
Safety and tolerability of IV administered ganaxolone as assessed by changes in physical examination

Secondary Outcome Measures

Maximal Plasma Concentration (Cmax) of Ganaxolone [34 days]
Analyze the Cmax of IV administered ganaxolone
Concentration of Steady State (Css) of Ganaxolone [34 days]
Analyze the Css of IV administered ganaxolone
Area Under the Plasma Concentration Curve (AUC) of Ganaxolone [34 days]
Analyze the AUC of IV administered ganaxolone
Hamilton Depression Rating Scale (HAMD17) [34 days]
Efficacy as assessed by HAMD17
Edinburgh Postnatal Depression Scale (EPDS) [34 days]
Efficacy as assessed by EPDS
Spielberger State-Trait Anxiety Inventory six item version (STA6) [34 days]
Efficacy as assessed by STA6
Clinical Global Impression [34 days]
Efficacy as assessed by CGI

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Subject 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 7.0 interview
Subject gave birth in the last 6 months
Subject has a HAMD17 score of ≥ 26 at screening
Subject 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 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marinus Research Site	Little Rock	Arkansas	United States	72211
2	Marinus Research Site	Costa Mesa	California	United States	92626
3	Marinus Research Site	Lemon Grove	California	United States	91945
4	Marinus Research Site	San Diego	California	United States	92103
5	Marinus Research Site	Jacksonville	Florida	United States	32216
6	Marinus Research Site	Atlanta	Georgia	United States	30331
7	Marinus Research Site	Decatur	Georgia	United States	30030
8	Marinus Research Site	Leawood	Kansas	United States	66206
9	Marinus Research Site	Overland Park	Kansas	United States	66211
10	Marinus Research Site	New York	New York	United States	10032
11	Marinus Research Site	Dayton	Ohio	United States	45417
12	Marinus Research Site	Houston	Texas	United States	77058
13	Marinus Research Site	Irving	Texas	United States	75062
14	Marinus Research Site	Orem	Utah	United States	84058
15	Marinus Research Site	Salt Lake City	Utah	United States	84124
16	Marinus Research Site	Richmond	Virginia	United States	23298