ClinicalTrials.gov
ClinicalTrials.gov Menu

A Clinical Trial of Oral Ganaxolone in Women With Postpartum Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03460756
Recruitment Status : Recruiting
First Posted : March 9, 2018
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
Marinus Pharmaceuticals

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 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 : December 28, 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ganaxolone
Oral
Drug: Ganaxolone
Oral

Placebo Comparator: Placebo
Oral
Drug: Placebo
Oral




Primary Outcome Measures :
  1. Hamilton Depression Rating Scale [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 38 Days ]
    Assessment of suicidal ideation or behavior by using the CSSRS scale.

  8. Electrocardiogram (ECG) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 10 days ]
    Number of individuals with potentially significant physical exam findings per group.


Secondary Outcome Measures :
  1. Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: 38 days ]
    Efficacy of oral administered ganaxolone vs. placebo as assessed by EPDS

  2. Spielberger State-Trait Anxiety Inventory six item version (STA6) [ Time Frame: 38 days ]
    Efficacy of oral administered ganaxolone vs. placebo as assessed by STA6

  3. Clinical Global Impression-Improvement [ Time Frame: 38 days ]
    Efficacy of oral administered ganaxolone vs. placebo as assessed by CGI-I



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women with postpartum depression
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03460756


Contacts
Contact: William Amerine 484-801-4676 wamerine@marinuspharma.com
Contact: Jaakko Lappalainen, MD 484 801 4678 jlappalainen@marinuspharma.com

Locations
United States, California
Marinus Research Site Recruiting
Lemon Grove, California, United States, 91945
United States, Florida
Marinus Research Site Recruiting
Jacksonville, Florida, United States, 32216
United States, Georgia
Marinus Research Site Recruiting
Decatur, Georgia, United States, 30030
United States, Kansas
Marinus Research Site Recruiting
Leawood, Kansas, United States, 66206
United States, Pennsylvania
Marinus Research Site Recruiting
Downingtown, Pennsylvania, United States, 19335
United States, Texas
Marinus Research Site Recruiting
Irving, Texas, United States, 75062
Sponsors and Collaborators
Marinus Pharmaceuticals
Investigators
Study Director: Jaakko Lappalainen, MD Marinus Pharmaceuticals

Responsible Party: Marinus Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03460756     History of Changes
Other Study ID Numbers: 1042-PPD-2003
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018

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
Depressive Disorder
Depression, Postpartum
Disease
Mental Disorders
Psychotic Disorders
Mood Disorders
Pregnancy Complications
Behavioral Symptoms
Puerperal Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Pregnanolone
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs