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Trial record 2 of 8 for:    PTSD and CRF

Analyzing Female Trauma Exposed Responses to a Medication (AFTER)

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ClinicalTrials.gov Identifier: NCT01814332
Recruitment Status : Completed
First Posted : March 19, 2013
Results First Posted : April 25, 2016
Last Update Posted : June 10, 2016
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
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 San Francisco VA Medical Center 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

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

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

Placebo

Placebo compound treatment for comparison with IP

Placebo: Placebo compound treatment for comparison with IP


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.
No text entered.

Reporting Groups
  Description
GSK561679

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

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

Placebo

Placebo compound treatment for comparison with IP

Placebo: Placebo compound treatment for comparison with IP

Total Total of all reporting groups

Baseline Measures
   GSK561679   Placebo   Total 
Overall Participants Analyzed 
[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 
Region of Enrollment 
[Units: Participants]
     
United States   63   65   128 


  Outcome Measures

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

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: Baseline, Week 6 ]


  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
No text entered.


  More Information

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


Results Point of Contact:  
Name/Title: Jennifer Hlavin
Organization: San Francisco VA Medical Center
phone: 415-221-4810 ext 26624
e-mail: jennifer.hlavin@va.gov



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01814332     History of Changes
Other Study ID Numbers: 09S-NIMH-002
First Submitted: March 11, 2013
First Posted: March 19, 2013
Results First Submitted: March 23, 2016
Results First Posted: April 25, 2016
Last Update Posted: June 10, 2016