Trial Outcomes & Findings for Evaluation of GSK561679 in Women With Post-Traumatic Stress Disorder (NCT NCT01018992)
NCT ID: NCT01018992
Last Updated: 2017-03-07
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
267 participants
Baseline, Week 6
2017-03-07
Participant Flow
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.
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.
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
65
|
|
Overall Study
COMPLETED
|
47
|
49
|
|
Overall Study
NOT COMPLETED
|
16
|
16
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
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
Evaluation of GSK561679 in Women With Post-Traumatic Stress Disorder
Baseline characteristics by cohort
| Measure |
GSK561679
n=63 Participants
Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
|
Placebo
n=65 Participants
Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
63 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
128 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
128 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 6Population: 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
Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
|
Placebo
n=65 Participants
Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
|
|---|---|---|
|
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 6Population: Intent to treat analysis was performed with missing subjects considered to be non-responders.
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).
Outcome measures
| Measure |
GSK561679
n=63 Participants
Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
|
Placebo
n=65 Participants
Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
|
|---|---|---|
|
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 6Population: Intent to treat analysis was performed using maximum likelihood estimation with mixed models to include all observations.
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.
Outcome measures
| Measure |
GSK561679
n=63 Participants
Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
|
Placebo
n=65 Participants
Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
|
|---|---|---|
|
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: Week 6Population: Intent to Treat
The occurrence of adverse events will be recorded at the end of 6 weeks.
Outcome measures
| Measure |
GSK561679
n=63 Participants
Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
|
Placebo
n=65 Participants
Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
|
|---|---|---|
|
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
Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
|
Placebo
n=65 participants at risk
Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma exacerbation
|
1.6%
1/63
|
0.00%
0/65
|
|
Immune system disorders
Anaphylaxis
|
0.00%
0/63
|
1.5%
1/65
|
Other adverse events
| Measure |
GSK561679
n=63 participants at risk
Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
|
Placebo
n=65 participants at risk
Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
|
|---|---|---|
|
Nervous system disorders
Headache
|
39.7%
25/63
|
36.9%
24/65
|
|
Gastrointestinal disorders
Nausea
|
30.2%
19/63
|
16.9%
11/65
|
|
Psychiatric disorders
Insomnia
|
9.5%
6/63
|
16.9%
11/65
|
|
Gastrointestinal disorders
Diarrhea
|
9.5%
6/63
|
13.8%
9/65
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
12.7%
8/63
|
10.8%
7/65
|
|
Nervous system disorders
Sedation
|
7.9%
5/63
|
12.3%
8/65
|
|
Nervous system disorders
Dizziness
|
11.1%
7/63
|
6.2%
4/65
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.2%
2/63
|
12.3%
8/65
|
|
Gastrointestinal disorders
Vomiting
|
6.3%
4/63
|
9.2%
6/65
|
|
Gastrointestinal disorders
Dyspepsia
|
6.3%
4/63
|
7.7%
5/65
|
|
Gastrointestinal disorders
Constipation
|
3.2%
2/63
|
7.7%
5/65
|
|
Gastrointestinal disorders
Dry Mouth
|
7.9%
5/63
|
3.1%
2/65
|
|
General disorders
Irritability
|
4.8%
3/63
|
6.2%
4/65
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
6.3%
4/63
|
4.6%
3/65
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.6%
1/63
|
7.7%
5/65
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.9%
5/63
|
1.5%
1/65
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.2%
2/63
|
6.2%
4/65
|
|
Psychiatric disorders
Depression
|
3.2%
2/63
|
4.6%
3/65
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
4.8%
3/63
|
3.1%
2/65
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
3.2%
2/63
|
4.6%
3/65
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
1.6%
1/63
|
6.2%
4/65
|
|
Eye disorders
Vision Blurred
|
3.2%
2/63
|
4.6%
3/65
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/63
|
6.2%
4/65
|
|
General disorders
Disturbance in attention
|
1.6%
1/63
|
4.6%
3/65
|
|
General disorders
Hypersensitivity
|
1.6%
1/63
|
4.6%
3/65
|
|
Nervous system disorders
Migraine
|
4.8%
3/63
|
1.5%
1/65
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
1.6%
1/63
|
4.6%
3/65
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.6%
1/63
|
4.6%
3/65
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/63
|
4.6%
3/65
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/63
|
4.6%
3/65
|
|
Endocrine disorders
Hot Flush
|
0.00%
0/63
|
4.6%
3/65
|
|
Endocrine disorders
Non-cardiac chest pain
|
0.00%
0/63
|
4.6%
3/65
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/63
|
4.6%
3/65
|
|
Ear and labyrinth disorders
Tinnitus
|
4.8%
3/63
|
0.00%
0/65
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place