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Analyzing Female Trauma Exposed Responses to a Medication

NCT01814332 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2021-06-25

Study results available
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Summary

This purpose of this study is to look at the safety of the experimental drug GSK561679 as well as its effects on PTSD symptoms, thinking and memory, startle reaction, stress hormones, and mental health symptoms in comparison to placebo (an inactive substance).

Conditions

  • Stress Disorders, Post-traumatic

Interventions

DRUG

GSK561679

GSK561679, oral administration, 350mg/day, 6 week administration

DRUG

Placebo

Placebo compound treatment for comparison with IP

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Thomas C. Neylan, MD · San Francisco VA Medical Center, San Francisco, CA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-01
Primary Completion
2014-06-30
Completion
2014-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01814332 on ClinicalTrials.gov