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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
Enrollment 267
Recruitment Details 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 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.
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
Period Title: Overall Study
Started 63 65
Completed 47 49
Not Completed 16 16
Reason Not Completed
Adverse Event             8             3
Withdrawal by Subject             3             8
Protocol Violation             0             4
Lost to Follow-up             5             1
Arm/Group Title GSK561679 Placebo Total
Hide Arm/Group Description Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks Total of all reporting groups
Overall Number of Baseline Participants 63 65 128
Hide Baseline Analysis Population Description
All participants randomized to receive the double-blind study medication
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 65 participants 128 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 65 participants 128 participants
Female
63
 100.0%
65
 100.0%
128
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Efficacy, Measured by Change in the Clinician-Administered PTSD Scale (CAPS) Score
Hide Description 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.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis was performed using maximum likelihood estimation with mixed models to include all observations.
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
Overall Number of Participants Analyzed 63 65
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-26.02  (22.28) -27.33  (19.76)
2.Secondary Outcome
Title Efficacy, Measured by Response Rate of at Least 50% Improvement in CAPS Score at the End of 6 Weeks as Compared to Baseline
Hide Description The number of participants that showed at least a 50% reduction in CAPS scores from their baseline visit at the end of 6 weeks were measured has having a response to the treatment. 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. Scores may range from 0 (no symptoms) to 136 (severe symptoms).
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis was performed with missing subjects considered to be non-responders.
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
Overall Number of Participants Analyzed 63 65
Measure Type: Number
Unit of Measure: participants
14 18
3.Secondary Outcome
Title Efficacy, Measured by Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score
Hide Description The MADRS is a ten-item clinician-administered questionnaire used to measure the severity of depressive symptoms in patients with depressive disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. Change is the difference in scores between baseline and 6 weeks.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis was performed using maximum likelihood estimation with mixed models to include all observations.
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
Overall Number of Participants Analyzed 63 65
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-7.83  (9.32) -5.98  (9.10)
4.Secondary Outcome
Title Safety, Measured by the Number of Subjects That Experienced an Adverse Event
Hide Description The occurrence of adverse events will be recorded at the end of 6 weeks.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
Overall Number of Participants Analyzed 63 65
Measure Type: Number
Unit of Measure: participants
55 55
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
All-Cause Mortality
GSK561679 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
GSK561679 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/63 (1.59%)   1/65 (1.54%) 
Immune system disorders     
Anaphylaxis  [1]  0/63 (0.00%)  1/65 (1.54%) 
Respiratory, thoracic and mediastinal disorders     
Asthma exacerbation  1/63 (1.59%)  0/65 (0.00%) 
Indicates events were collected by systematic assessment
[1]
Anaphylactic reaction to seafood in person with known allergy to seafood
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GSK561679 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   55/63 (87.30%)   55/65 (84.62%) 
Ear and labyrinth disorders     
Tinnitus  3/63 (4.76%)  0/65 (0.00%) 
Endocrine disorders     
Hot Flush  0/63 (0.00%)  3/65 (4.62%) 
Non-cardiac chest pain  0/63 (0.00%)  3/65 (4.62%) 
Eye disorders     
Vision Blurred  2/63 (3.17%)  3/65 (4.62%) 
Gastrointestinal disorders     
Nausea  19/63 (30.16%)  11/65 (16.92%) 
Diarrhea  6/63 (9.52%)  9/65 (13.85%) 
Vomiting  4/63 (6.35%)  6/65 (9.23%) 
Dyspepsia  4/63 (6.35%)  5/65 (7.69%) 
Constipation  2/63 (3.17%)  5/65 (7.69%) 
Dry Mouth  5/63 (7.94%)  2/65 (3.08%) 
Abdominal Pain  1/63 (1.59%)  5/65 (7.69%) 
Abdominal distension  0/63 (0.00%)  3/65 (4.62%) 
Flatulence  0/63 (0.00%)  3/65 (4.62%) 
General disorders     
Irritability  3/63 (4.76%)  4/65 (6.15%) 
Disturbance in attention  1/63 (1.59%)  3/65 (4.62%) 
Hypersensitivity  1/63 (1.59%)  3/65 (4.62%) 
Infections and infestations     
Upper Respiratory Tract Infection  8/63 (12.70%)  7/65 (10.77%) 
Injury, poisoning and procedural complications     
Contusion  0/63 (0.00%)  4/65 (6.15%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  5/63 (7.94%)  1/65 (1.54%) 
Neck Pain  3/63 (4.76%)  2/65 (3.08%) 
Muscle spasm  1/63 (1.59%)  3/65 (4.62%) 
Myalgia  1/63 (1.59%)  3/65 (4.62%) 
Nervous system disorders     
Headache  25/63 (39.68%)  24/65 (36.92%) 
Sedation  5/63 (7.94%)  8/65 (12.31%) 
Dizziness  7/63 (11.11%)  4/65 (6.15%) 
Migraine  3/63 (4.76%)  1/65 (1.54%) 
Psychiatric disorders     
Insomnia  6/63 (9.52%)  11/65 (16.92%) 
Depression [1]  2/63 (3.17%)  3/65 (4.62%) 
Respiratory, thoracic and mediastinal disorders     
Cough  2/63 (3.17%)  4/65 (6.15%) 
Rhinitis Allergic  2/63 (3.17%)  3/65 (4.62%) 
Sinusitis  1/63 (1.59%)  4/65 (6.15%) 
Oropharyngeal Pain  0/63 (0.00%)  3/65 (4.62%) 
Skin and subcutaneous tissue disorders     
Rash  2/63 (3.17%)  8/65 (12.31%) 
Pruritis  4/63 (6.35%)  3/65 (4.62%) 
[1]
worse than baseline
Limitations of this trial include short duration of treatment (6 weeks) and generalizability due to study population composed of only females.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Boadie Dunlop
Organization: Emory University
Phone: 404-727-8474
EMail: bdunlop@emory.edu
Layout table for additonal information
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