Trial Outcomes & Findings for Analyzing Female Trauma Exposed Responses to a Medication (NCT NCT01814332)
NCT ID: NCT01814332
Last Updated: 2021-06-25
Results Overview
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.
COMPLETED
PHASE2
128 participants
Baseline, 6 weeks
2021-06-25
Participant Flow
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.
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.
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
65
|
|
Overall Study
COMPLETED
|
47
|
49
|
|
Overall Study
NOT COMPLETED
|
16
|
16
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
Adverse Event
|
8
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
8
|
|
Overall Study
Protocol Violation
|
0
|
4
|
|
Overall Study
Lost to Follow-up
|
5
|
1
|
Baseline Characteristics
Analyzing Female Trauma Exposed Responses to a Medication
Baseline characteristics by cohort
| Measure |
GSK561679
n=63 Participants
GSK561679, oral administration, 350mg/day, 6 week administration
GSK561679: GSK561679, oral administration, 350mg/day, 6 week administration
|
Placebo
n=65 Participants
Placebo compound treatment for comparison with IP
Placebo: Placebo compound treatment for comparison with IP
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
63 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
63 participants
n=5 Participants
|
65 participants
n=7 Participants
|
128 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 weeksPopulation: Intent to treat analysis was performed using maximum likelihood estimation with mixed models to include all observations.
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.
Outcome measures
| Measure |
GSK561679
n=63 Participants
GSK561679, oral administration, 350mg/day, 6 week administration
GSK561679: GSK561679, oral administration, 350mg/day, 6 week administration
|
Placebo
n=65 Participants
Placebo compound treatment for comparison with IP
Placebo: Placebo compound treatment for comparison with IP
|
|---|---|---|
|
Efficacy, Measured by Change in the Clinician-Administered PTSD Scale (CAPS) Score
|
-26.02 score on a scale
Standard Deviation 22.28
|
-27.33 score on a scale
Standard Deviation 19.76
|
SECONDARY outcome
Timeframe: Baseline, Week 6The 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 as 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).
Outcome measures
| Measure |
GSK561679
n=63 Participants
GSK561679, oral administration, 350mg/day, 6 week administration
GSK561679: GSK561679, oral administration, 350mg/day, 6 week administration
|
Placebo
n=65 Participants
Placebo compound treatment for comparison with IP
Placebo: Placebo compound treatment for comparison with IP
|
|---|---|---|
|
Efficacy, Measured by Response Rate of at Least 50% Improvement in CAPS Score at the End of 6 Weeks as Compared to Baseline
|
14 participants
|
18 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 6The 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.
Outcome measures
| Measure |
GSK561679
n=63 Participants
GSK561679, oral administration, 350mg/day, 6 week administration
GSK561679: GSK561679, oral administration, 350mg/day, 6 week administration
|
Placebo
n=65 Participants
Placebo compound treatment for comparison with IP
Placebo: Placebo compound treatment for comparison with IP
|
|---|---|---|
|
Efficacy, Measured by Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score
|
-7.83 Score on a scale
Standard Deviation 9.32
|
-5.98 Score on a scale
Standard Deviation 9.10
|
SECONDARY outcome
Timeframe: Baseline, Week 6The occurrence of adverse events will be recorded at the end of 6 weeks.
Outcome measures
| Measure |
GSK561679
n=63 Participants
GSK561679, oral administration, 350mg/day, 6 week administration
GSK561679: GSK561679, oral administration, 350mg/day, 6 week administration
|
Placebo
n=65 Participants
Placebo compound treatment for comparison with IP
Placebo: Placebo compound treatment for comparison with IP
|
|---|---|---|
|
Safety, Measured by the Number of Subjects That Experienced an Adverse Event
|
55 participants
|
55 participants
|
Adverse Events
GSK561679
Placebo
Serious adverse events
| Measure |
GSK561679
n=63 participants at risk
GSK561679, oral administration, 350mg/day, 6 week administration
GSK561679: GSK561679, oral administration, 350mg/day, 6 week administration
|
Placebo
n=65 participants at risk
Placebo compound treatment for comparison with IP
Placebo: Placebo compound treatment for comparison with IP
|
|---|---|---|
|
Immune system disorders
Anaphylaxis
|
0.00%
0/63
|
1.5%
1/65 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Asthma exacerbation
|
1.6%
1/63 • Number of events 1
|
0.00%
0/65
|
Other adverse events
| Measure |
GSK561679
n=63 participants at risk
GSK561679, oral administration, 350mg/day, 6 week administration
GSK561679: GSK561679, oral administration, 350mg/day, 6 week administration
|
Placebo
n=65 participants at risk
Placebo compound treatment for comparison with IP
Placebo: Placebo compound treatment for comparison with IP
|
|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
4.8%
3/63 • Number of events 3
|
0.00%
0/65
|
|
Endocrine disorders
Hot Flush
|
0.00%
0/63
|
4.6%
3/65 • Number of events 3
|
|
Endocrine disorders
Non-cardiac chest pain
|
0.00%
0/63
|
4.6%
3/65 • Number of events 3
|
|
Eye disorders
Vision Blurred
|
3.2%
2/63 • Number of events 2
|
4.6%
3/65 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
30.2%
19/63 • Number of events 19
|
16.9%
11/65 • Number of events 11
|
|
Gastrointestinal disorders
Diarrhea
|
9.5%
6/63 • Number of events 6
|
13.8%
9/65 • Number of events 9
|
|
Gastrointestinal disorders
Vomiting
|
6.3%
4/63 • Number of events 4
|
9.2%
6/65 • Number of events 6
|
|
Gastrointestinal disorders
Dyspepsia
|
6.3%
4/63 • Number of events 4
|
7.7%
5/65 • Number of events 5
|
|
Gastrointestinal disorders
Constipation
|
3.2%
2/63 • Number of events 2
|
7.7%
5/65 • Number of events 5
|
|
Gastrointestinal disorders
Dry Mouth
|
7.9%
5/63 • Number of events 5
|
3.1%
2/65 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.6%
1/63 • Number of events 1
|
7.7%
5/65 • Number of events 5
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/63
|
4.6%
3/65 • Number of events 3
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/63
|
4.6%
3/65 • Number of events 3
|
|
General disorders
Irritability
|
4.8%
3/63 • Number of events 3
|
6.2%
4/65 • Number of events 4
|
|
General disorders
Disturbance in attention
|
1.6%
1/63 • Number of events 1
|
4.6%
3/65 • Number of events 3
|
|
General disorders
Hypersensitivity
|
1.6%
1/63 • Number of events 1
|
4.6%
3/65 • Number of events 3
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
12.7%
8/63 • Number of events 8
|
10.8%
7/65 • Number of events 7
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/63
|
6.2%
4/65 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.9%
5/63 • Number of events 5
|
1.5%
1/65 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
4.8%
3/63 • Number of events 3
|
3.1%
2/65 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
1.6%
1/63 • Number of events 1
|
4.6%
3/65 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.6%
1/63 • Number of events 1
|
4.6%
3/65 • Number of events 3
|
|
Nervous system disorders
Headache
|
39.7%
25/63 • Number of events 25
|
36.9%
24/65 • Number of events 24
|
|
Nervous system disorders
Sedation
|
7.9%
5/63 • Number of events 5
|
12.3%
8/65 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Dizziness
|
11.1%
7/63 • Number of events 7
|
6.2%
4/65 • Number of events 4
|
|
Nervous system disorders
Migraine
|
4.8%
3/63 • Number of events 3
|
1.5%
1/65 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
9.5%
6/63 • Number of events 6
|
16.9%
11/65 • Number of events 11
|
|
Psychiatric disorders
Depression
|
3.2%
2/63 • Number of events 2
|
4.6%
3/65 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.2%
2/63 • Number of events 2
|
6.2%
4/65 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
3.2%
2/63 • Number of events 2
|
4.6%
3/65 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
1.6%
1/63 • Number of events 1
|
6.2%
4/65 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/63
|
4.6%
3/65 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.2%
2/63 • Number of events 2
|
12.3%
8/65 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
6.3%
4/63 • Number of events 4
|
4.6%
3/65 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place