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Completed Phase 2 Interventional Results available

Ganaxolone in Posttraumatic Stress Disorder (PTSD)

ClinicalTrials.gov ID: NCT01339689

Public ClinicalTrials.gov record NCT01339689. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 8:41 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Proof-of-Concept, Double-blind, Randomized, Placebo-controlled Study of Ganaxolone in Posttraumatic Stress Disorder

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This Phase 2 proof-of-concept study is a double-blind, randomized, placebo-controlled, 15-week investigation of ganaxolone versus placebo for the treatment of Posttraumatic Stress Disorder (PTSD). Up to 120 participants will be enrolled and randomized to receive either ganaxolone or placebo for 6 weeks. After 6 weeks of randomized treatment all participants will continue for 6 weeks on ganaxolone. The aim of the study is to assess the efficacy of ganaxolone compared to placebo for the treatment of PTSD symptoms after 6 weeks of treatment using the Clinician-Administered PTSD Rating Scale (CAPS). The second aim of the study is to evaluate the safety and tolerability of ganaxolone in the PTSD population.

Study identification

NCT ID
NCT01339689
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Marinus Pharmaceuticals
Industry
Enrollment
112 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 55 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 31, 2011
Primary completion
Dec 31, 2013
Completion
Feb 28, 2014
Last update posted
Dec 28, 2022

2011 – 2014

United States locations

U.S. sites
8
U.S. states
8
U.S. cities
8
Facility City State ZIP Site status
VA San Diego Healthcare System/ University of California, San Diego San Diego California 92093
Washington DC VA Medical Center/ Uniformed Services University of the Health Services Washington D.C. District of Columbia 20422
VA Boston Healthcare Services/ Spaulding Rehabilitation Hospital Boston Massachusetts 02130
Manchester VA Medical Center/ Dartmouth College Manchester New Hampshire 03104
Durham VA Medical Center /Duke University Medical Center Durham North Carolina 27705
Cincinnati VA Medical Center/ University of Cincinnati Cincinnati Ohio 45220
Charleston VA Medica Center/ Medical University of South Carolina Charleston South Carolina 29401
White River Junction VA Medical Center/ Dartmouth College White River Junction Vermont 05009

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01339689, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 28, 2022 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01339689 live on ClinicalTrials.gov.

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