Ganaxolone in Posttraumatic Stress Disorder (PTSD)
This trial is active, not recruiting.
|Collaborator||INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium|
|Start date||April 2011|
|End date||January 2014|
|Trial size||114 participants|
|Trial identifier||NCT01339689, 1042-0700|
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 subjects will be enrolled and randomized to receive either ganaxolone or placebo for 6 weeks. After 6 wks of randomized treatment all subjects will continue for 6 wks 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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|San Diego, CA||VA San Diego Healthcare System/ University of California, San Diego||no longer recruiting|
|Washington DC, DC||Washington DC VA Medical Center/ Uniformed Services University of the Health Services||no longer recruiting|
|Boston, MA||VA Boston Healthcare Services/ Spaulding Rehabilitation Hospital||no longer recruiting|
|Manchester, NH||Manchester VA Medical Center/ Dartmouth College||no longer recruiting|
|Durham, NC||Durham VA Medical Center /Duke University Medical Center||no longer recruiting|
|Cincinnati, OH||Cincinnati VA Medical Center/ University of Cincinnati||no longer recruiting|
|Charleston, SC||Charleston VA Medica Center/ Medical University of South Carolina||no longer recruiting|
|White River Junction, VT||White River Junction VA Medical Center/ Dartmouth College||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Clinician-Administered PTSD Scale (CAPS) scores.
time frame: 6 weeks
time frame: 6 weeks
Male or female participants from 18 years up to 55 years old.
Key Inclusion Criteria: - Veteran or civilian adult outpatients 18-55 years of age, with primary PTSD as defined by DSM-IV for at least 6 months - 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 subjects are required to use a medically acceptable form of birth control Key Exclusion Criteria - Clinically unstable medical disease; progressive CNS disorder/disease; history of seizures (except childhood febrile seizure); moderate or severe traumatic brain injury (TBI) - Females who are pregnant or currently breast feeding - Current or past psychotic disorder, bipolar Type I disorder, or dementia - Subjects with recent drug abuse or dependency (excluding nicotine and caffeine) - Subjects 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 - Subjects with pending litigation related to the traumatic event - Subjects who are unwilling to withhold grapefruit or grapefruit juice for the duration of the study - Subjects receiving psychotherapy without a stable paradigm for at least 3 months - Non-English speaking subjects
|Official title||A Proof-of-Concept, Double-blind, Randomized, Placebo-controlled Study of Ganaxolone in Posttraumatic Stress Disorder|
|Principal investigator||Christine E Marx, MD, MA|
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