Evaluation of GSK561679 in Women With Post-Traumatic Stress Disorder

This study has been completed.
Sponsor:
Collaborator:
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Boadie W. Dunlop, Emory University
ClinicalTrials.gov Identifier:
NCT01018992
First received: November 6, 2009
Last updated: July 2, 2015
Last verified: July 2015
Results First Received: July 2, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Diagnostic
Condition: Stress Disorders, Post-Traumatic
Interventions: Drug: GSK561679
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from Emory University School of Medicine, Mount Sinai School of Medicine, Baylor College of Medicine, and the University of California San Francisco between January 2010 and June 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects stopped psychotropic medications (w/ the exception of zolpidem, eszopiclone, and zaleplon for insomnia) w/in 2 weeks (6 weeks for fluoxetine) of Visit 1. Patients on ineffective psychotropic medications tapered off by the patients’ prescribing doctor. 150 subjects did not proceed to randomization due to meeting exclusionary criteria.

Reporting Groups
  Description
GSK561679 Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
Placebo Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks

Participant Flow:   Overall Study
    GSK561679     Placebo  
STARTED     63     65  
COMPLETED     47     49  
NOT COMPLETED     16     16  
Adverse Event                 8                 3  
Withdrawal by Subject                 3                 8  
Protocol Violation                 0                 4  
Lost to Follow-up                 5                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants randomized to receive the double-blind study medication

Reporting Groups
  Description
GSK561679 Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
Placebo Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
Total Total of all reporting groups

Baseline Measures
    GSK561679     Placebo     Total  
Number of Participants  
[units: participants]
  63     65     128  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     63     65     128  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     63     65     128  
Male     0     0     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Efficacy, Measured by Change in the Clinician-Administered PTSD Scale (CAPS) Score   [ Time Frame: Baseline, Week 6 ]

2.  Secondary:   Efficacy, Measured by Response Rate of at Least 50% Improvement in CAPS Score at the End of 6 Weeks as Compared to Baseline   [ Time Frame: Baseline, Week 6 ]

3.  Secondary:   Efficacy, Measured by Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score   [ Time Frame: Baseline, Week 6 ]

4.  Secondary:   Safety, Measured by the Number of Subjects That Experienced an Adverse Event   [ Time Frame: Week 6 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Limitations of this trial include short duration of treatment (6 weeks) and generalizability due to study population composed of only females.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Boadie Dunlop
Organization: Emory University
phone: 404-727-8474
e-mail: bdunlop@emory.edu


No publications provided by Emory University

Publications automatically indexed to this study:

Responsible Party: Boadie W. Dunlop, Emory University
ClinicalTrials.gov Identifier: NCT01018992     History of Changes
Other Study ID Numbers: IRB00022717, MH069056
Study First Received: November 6, 2009
Results First Received: July 2, 2015
Last Updated: July 2, 2015
Health Authority: United States: Food and Drug Administration