Phase 2
N=128
Analyzing Female Trauma Exposed Responses to a Medication
Stress Disorders, Post-traumatic
Bottom Line
View on ClinicalTrials.gov: NCT01814332 ↗Enrolled (actual)
128
Serious AEs
1.6%
Results posted
Apr 2016
Primary outcome: Primary: Efficacy, Measured by Change in the Clinician-Administered PTSD Scale (CAPS) Score — -26.02; -27.33 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- GSK561679 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy, Measured by Change in the Clinician-Administered PTSD Scale (CAPS) Score |
-26.02; -27.33 | — |
| SECONDARY Efficacy, Measured by Response Rate of at Least 50% Improvement in CAPS Score at the End of 6 Weeks as Compared to Baseline |
14; 18 | — |
| SECONDARY Efficacy, Measured by Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score |
-7.83; -5.98 | — |
| SECONDARY Safety, Measured by the Number of Subjects That Experienced an Adverse Event |
55; 55 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Female between 18-65 years of age
- Able to provide consent and willing to participate in research
- PTSD duration of illness at least 3 months
- Negative Urine toxicology test
- Agrees to use protocol-defined effective birth control method
Exclusion Criteria
- Subject is currently participating in another clinical trial in which she is or will be exposed to an investigational or non-investigational drug or device, or has done so within the preceding month for studies unrelated to PTSD, or 1 month for studies related to PTSD
- Subject has a documented history of hepato-biliary disease including a history of, or positive laboratory results for hepatitis
- Subject requires ongoing treatment with medications that are prohibited per protocol
- Subject has a stool positive for occult blood.
- Pregnancy or lactation
Data sourced from ClinicalTrials.gov (NCT01814332). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.