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Evaluation of GSK561679 in Women With Post-Traumatic Stress Disorder

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ClinicalTrials.gov Identifier: NCT01018992
Recruitment Status : Completed
First Posted : November 25, 2009
Results First Posted : July 30, 2015
Last Update Posted : March 7, 2017
Sponsor:
Collaborator:
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Boadie W. Dunlop, Emory University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Diagnostic
Condition: Stress Disorders, Post-Traumatic
Interventions: Drug: GSK561679
Drug: Placebo

  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. 139 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

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 
Overall Participants Analyzed 
[Units: Participants]
 		 63   65   128 
Age 
[Units: Participants]
Count of Participants 		     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      63 100.0%      65 100.0%      128 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		     
Female      63 100.0%      65 100.0%      128 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures

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

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 ]
  Show Outcome Measure 2

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

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


  Serious Adverse Events


  Other Adverse Events


  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

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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Boadie W. Dunlop, Emory University
ClinicalTrials.gov Identifier: NCT01018992     History of Changes
Other Study ID Numbers: IRB00022717
MH069056 ( Other Identifier: Other )
First Submitted: November 6, 2009
First Posted: November 25, 2009
Results First Submitted: July 2, 2015
Results First Posted: July 30, 2015
Last Update Posted: March 7, 2017