Ganaxolone in Posttraumatic Stress Disorder (PTSD)

Status:	Completed
Conditions:	Psychiatric
Therapuetic Areas:	Psychiatry / Psychology
Healthy:	No
Age Range:	18 - 55
Updated:	4/21/2016
Start Date:	April 2011
End Date:	March 2014

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

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.

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

We found this trial at

sites

VA San Diego Healthcare System/ University of California, San Diego

San Diego, California 92093

105

from 91732

San Diego, CA