NCT01814332

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 19, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2014

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

April 25, 2016

Completed
Last Updated

June 25, 2021

Status Verified

June 1, 2021

Enrollment Period

4.5 years

First QC Date

March 11, 2013

Results QC Date

March 23, 2016

Last Update Submit

June 23, 2021

Conditions

Stress Disorders, Post-traumatic

Keywords

Stress disorders, Post-traumaticSleep

Outcome Measures

Primary Outcomes (1)

  • Efficacy, Measured by Change in the Clinician-Administered PTSD Scale (CAPS) Score

    The CAPS is a semi-structured clinical interview providing a measure of the severity of PTSD symptoms. A severity score is calculated by summing the frequency and intensity scores for each of the 17 DSM-IV criteria symptoms. The severity of symptoms is rated on a scale from 0-4, where, 0 = Absent, 1 = Mild/subthreshold; 2 = Moderate/ threshold, 3 = Severe/markedly elevated and 4 = Extreme/ incapacitating. Scores may range from 0 (no symptoms) to 136 (severe symptoms). Change is the difference in scores between baseline and 6 weeks.

    Baseline, 6 weeks

Secondary Outcomes (3)

  • Efficacy, Measured by Response Rate of at Least 50% Improvement in CAPS Score at the End of 6 Weeks as Compared to Baseline

    Baseline, Week 6

  • Efficacy, Measured by Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score

    Baseline, Week 6

  • Safety, Measured by the Number of Subjects That Experienced an Adverse Event

    Baseline, Week 6

Study Arms (2)

GSK561679

EXPERIMENTAL

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

Drug: GSK561679

Placebo

PLACEBO COMPARATOR

Placebo compound treatment for comparison with IP

Drug: Placebo

Interventions

GSK561679DRUG

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

Also known as: CRF1 antagonist
GSK561679
PlaceboDRUG

Placebo compound treatment for comparison with IP

Also known as: Sugar pill
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

NBI 77860Sugars

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Carbohydrates

Results Point of Contact

Title
Jennifer Hlavin
Organization
San Francisco VA Medical Center
jennifer.hlavin@va.gov
415-221-4810

Study Officials

  • Thomas C. Neylan, MD

    San Francisco VA Medical Center, San Francisco, CA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2013

First Posted

March 19, 2013

Study Start

January 1, 2010

Primary Completion

June 30, 2014

Study Completion

October 31, 2014

Last Updated

June 25, 2021

Results First Posted

April 25, 2016

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)