Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
112 participants
INTERVENTIONAL
2011-04-30
2014-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ganaxolone
active
Ganaxolone
200-600 mg bid, capsules, up to 12 weeks
Placebo
non-active
Placebo
capsules, bid, up to 12 weeks
Interventions
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Ganaxolone
200-600 mg bid, capsules, up to 12 weeks
Placebo
capsules, bid, up to 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must be in general good health-confirmed by medical history, physical examination, and screening laboratory results
* Negative urine drug screen for drugs of abuse
* Negative urine pregnancy test for females of childbearing potential
* Sexually active participants are required to use a medically acceptable form of birth control
Exclusion Criteria
* Females who are pregnant or currently breast feeding
* Current or past psychotic disorder, bipolar Type I disorder, or dementia
* Participants with recent drug abuse or dependency (excluding nicotine and caffeine)
* Participants unwilling to comply with the required alcohol prohibition during the trial
* Current suicidal or homicidal ideation necessitating intervention, and those with a history of suicide attempt in the past 10 years
* Participants with pending litigation related to the traumatic event
* Participants who are unwilling to withhold grapefruit or grapefruit juice for the duration of the study
* Participants receiving psychotherapy without a stable paradigm for at least 3 months
* Non-English speaking participants.
18 Years
55 Years
ALL
No
Sponsors
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INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
OTHER
U.S. Army Medical Research and Development Command
FED
Marinus Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Christine E Marx, MD, MA
Role: PRINCIPAL_INVESTIGATOR
Duke University Medical Center and Durham VA Medical Center
Ann Rasmusson, MD
Role: PRINCIPAL_INVESTIGATOR
Boston University School of Medicine Research Affiliate, National Center for PTSD
Locations
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VA San Diego Healthcare System/ University of California, San Diego
San Diego, California, United States
Washington DC VA Medical Center/ Uniformed Services University of the Health Services
Washington D.C., District of Columbia, United States
VA Boston Healthcare Services/ Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States
Manchester VA Medical Center/ Dartmouth College
Manchester, New Hampshire, United States
Durham VA Medical Center /Duke University Medical Center
Durham, North Carolina, United States
Cincinnati VA Medical Center/ University of Cincinnati
Cincinnati, Ohio, United States
Charleston VA Medica Center/ Medical University of South Carolina
Charleston, South Carolina, United States
White River Junction VA Medical Center/ Dartmouth College
White River Junction, Vermont, United States
Countries
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References
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Rasmusson AM, Marx CE, Jain S, Farfel GM, Tsai J, Sun X, Geracioti TD, Hamner MB, Lohr J, Rosse R, Summerall L, Naylor JC, Cusin C, Lang AJ, Raman R, Stein MB. A randomized controlled trial of ganaxolone in posttraumatic stress disorder. Psychopharmacology (Berl). 2017 Aug;234(15):2245-2257. doi: 10.1007/s00213-017-4649-y. Epub 2017 Jul 1.
Other Identifiers
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1042-0700
Identifier Type: -
Identifier Source: org_study_id