Trial Outcomes & Findings for Eszopiclone for the Treatment of Posttraumatic Stress Disorder (NCT NCT01605253)
NCT ID: NCT01605253
Last Updated: 2022-12-23
Results Overview
The Clinician-Administered PTSD Scale (CAPS) is a highly detailed measure of the presence and severity of the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-IV) Post-Traumatic Stress Disorder (PTSD) criteria. The severity score was calculated by adding up the frequency score (scale 0 = "none of the time" to 4 = "most or all of the time") and an intensity score (scale 0 = "none" to 4 = "extreme"), which can then be summed for all 17 symptom questions and/or for the three symptom clusters. Scores range from 0 to 136, where greater than or equal to 80 represents extreme PTSD symptomatology.
COMPLETED
PHASE4
81 participants
Between Baseline and Week 12
2022-12-23
Participant Flow
Participant milestones
| Measure |
Eszopiclone
Participants receives 3mg of eszopiclone nightly for 12 weeks, followed by a one month follow-up.
|
Placebo
Participants receives 3mg of placebo nightly for 12 weeks, followed by a one month follow-up.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
|
Overall Study
COMPLETED
|
7
|
9
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
Eszopiclone
Participants receives 3mg of eszopiclone nightly for 12 weeks, followed by a one month follow-up.
|
Placebo
Participants receives 3mg of placebo nightly for 12 weeks, followed by a one month follow-up.
|
|---|---|---|
|
Overall Study
Physician Decision
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
Baseline Characteristics
Eszopiclone for the Treatment of Posttraumatic Stress Disorder
Baseline characteristics by cohort
| Measure |
Eszopiclone
n=13 Participants
The total study duration is 16 weeks, with subjects taking 3mg eszopiclone at bedtime for 12 weeks. There is one follow-up visit after the 12 week treatment phase.
Eszopiclone: Eszopiclone has been approved by the US Food and Drug Administration (FDA) for the treatment of insomnia (inability to sleep). Eszopiclone has not been specifically approved by the FDA for people who have PTSD-related sleep disturbance.
|
Placebo
n=12 Participants
The total study duration is 16 weeks, with subjects taking placebo at bedtime for 12 weeks. There is one follow-up visit after the 12 week treatment phase.
Placebo: The placebo used in this study looks exactly like eszopiclone but contains no active ingredients.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Between Baseline and Week 12Population: Of the 25 subjects that were randomized, 9 did not complete the study.
The Clinician-Administered PTSD Scale (CAPS) is a highly detailed measure of the presence and severity of the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-IV) Post-Traumatic Stress Disorder (PTSD) criteria. The severity score was calculated by adding up the frequency score (scale 0 = "none of the time" to 4 = "most or all of the time") and an intensity score (scale 0 = "none" to 4 = "extreme"), which can then be summed for all 17 symptom questions and/or for the three symptom clusters. Scores range from 0 to 136, where greater than or equal to 80 represents extreme PTSD symptomatology.
Outcome measures
| Measure |
Eszopiclone
n=7 Participants
Participants receives 3mg of eszopiclone nightly for 12 weeks, followed by a one month follow-up.
|
Placebo
n=9 Participants
Participants receives 3mg of placebo nightly for 12 weeks, followed by a one month follow-up.
|
|---|---|---|
|
Change in Symptoms of Post-Traumatic Stress Disorder (PTSD) Between Baseline and Week 12
|
-23 units on a scale
Standard Deviation 17.61
|
-20 units on a scale
Standard Deviation 15.22
|
SECONDARY outcome
Timeframe: Changes in total score between Baseline and Week 12 (range of 0 to 21 worse)Population: Of the 25 subjects that were randomized, 9 did not complete the study.
This standard daily sleep diary addresses timing of sleep, ability to fall and stay asleep, dreams, nightmares, and factors which can affect sleep (e.g. caffeine). It requires a summary of the subscales: Duration of sleep + Sleep Disturbance + Sleep Latency + Days of dysfunction due to sleepiness + Sleep efficiency + Overall Sleep Quality + Needing medication to sleep. All subscales are measured from 0 to 3 (Minimum Score = 0 better; Maximum Score = 3 worse). The Minimum TOTAL Score is 0 (better) and Maximum TOTAL Score is 21 (worse).
Outcome measures
| Measure |
Eszopiclone
n=7 Participants
Participants receives 3mg of eszopiclone nightly for 12 weeks, followed by a one month follow-up.
|
Placebo
n=9 Participants
Participants receives 3mg of placebo nightly for 12 weeks, followed by a one month follow-up.
|
|---|---|---|
|
Total Score on the Pittsburgh Sleep Quality Index With Post-Traumatic Stress Disorder Addendum (PSQI)
|
-4.13 units on a scale
Standard Deviation 2.93
|
-3.33 units on a scale
Standard Deviation 3.59
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: Subjects with pre treatment and post treatment emotional bias encoding assessments
Changes in Emotional Bias Memory Encoding by measuring mean hits minus the false alarms at baseline and at week 12. Subjects perform an encoding session on the 1st day utilizing 147 picture slides, thirty six pictures with negative valence, 36 with neutral valence and additional 75 pictures randomly intermixed. Higher false alarms are associated with lower emotional bias memory encoding.
Outcome measures
| Measure |
Eszopiclone
n=5 Participants
Participants receives 3mg of eszopiclone nightly for 12 weeks, followed by a one month follow-up.
|
Placebo
n=4 Participants
Participants receives 3mg of placebo nightly for 12 weeks, followed by a one month follow-up.
|
|---|---|---|
|
Changes in Emotional Bias Memory Encoding Between Baseline and Week 12
|
93 units on a scale
Standard Error 31
|
102 units on a scale
Standard Error 32
|
SECONDARY outcome
Timeframe: Week 12Population: Subjects with baseline and week 12 cytokine assessments
Differences between baseline and week 12 on Interferon-Gamma, Interleukin-βeta, Interleukin-6, Tumor Necrosis Factor-alpha levels between treatment arms (eszopiclone versus placebo).
Outcome measures
| Measure |
Eszopiclone
n=11 Participants
Participants receives 3mg of eszopiclone nightly for 12 weeks, followed by a one month follow-up.
|
Placebo
n=10 Participants
Participants receives 3mg of placebo nightly for 12 weeks, followed by a one month follow-up.
|
|---|---|---|
|
Cytokine Inflammatory Markers
Interferon-GAMMA pg/mL
|
3.62 pg/ml
Standard Deviation 13.98
|
-1.55 pg/ml
Standard Deviation 6.35
|
|
Cytokine Inflammatory Markers
Interleukin-βeta pg/mL
|
-0.10 pg/ml
Standard Deviation 4
|
0.30 pg/ml
Standard Deviation 7
|
|
Cytokine Inflammatory Markers
Interleukin-6 pg/mL
|
1.29 pg/ml
Standard Deviation 8
|
-0.08 pg/ml
Standard Deviation 9
|
|
Cytokine Inflammatory Markers
Tumor Necrosis Factor-alpha pg/mL
|
67.27 pg/ml
Standard Deviation 11
|
64.80 pg/ml
Standard Deviation 10
|
SECONDARY outcome
Timeframe: Week 12Population: Subjects with baseline and week 12 cytokine assessment of Interleukin-2 IU
Differences between baseline and week 12 on Interleukin-2 levels between treatment arms (eszopiclone versus placebo).
Outcome measures
| Measure |
Eszopiclone
n=10 Participants
Participants receives 3mg of eszopiclone nightly for 12 weeks, followed by a one month follow-up.
|
Placebo
n=11 Participants
Participants receives 3mg of placebo nightly for 12 weeks, followed by a one month follow-up.
|
|---|---|---|
|
Cytokine Inflammatory Marker on Interleukin-2
|
1.67 IU
Standard Deviation 8
|
-0.07 IU
Standard Deviation 9
|
Adverse Events
Eszopiclone
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Eszopiclone
n=13 participants at risk
Participants receives 3mg of eszopiclone nightly for 12 weeks, followed by a one month follow-up.
|
Placebo
n=12 participants at risk
Participants receives 3mg of placebo nightly for 12 weeks, followed by a one month follow-up.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
7.7%
1/13 • Number of events 1
|
8.3%
1/12 • Number of events 2
|
|
Metabolism and nutrition disorders
Appetite Increase
|
7.7%
1/13 • Number of events 2
|
0.00%
0/12
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Dry mouth
|
7.7%
1/13 • Number of events 1
|
16.7%
2/12 • Number of events 9
|
|
General disorders
Dysgeusia
|
30.8%
4/13 • Number of events 20
|
25.0%
3/12 • Number of events 7
|
|
Gastrointestinal disorders
GI distress
|
15.4%
2/13 • Number of events 5
|
8.3%
1/12 • Number of events 3
|
|
General disorders
Dizziness
|
0.00%
0/13
|
8.3%
1/12 • Number of events 2
|
|
General disorders
Headache
|
15.4%
2/13 • Number of events 4
|
25.0%
3/12 • Number of events 5
|
|
General disorders
Jitteriness
|
0.00%
0/13
|
8.3%
1/12 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle cramping
|
0.00%
0/13
|
8.3%
1/12 • Number of events 3
|
|
General disorders
Memory impairment
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Reproductive system and breast disorders
Sexual dysfunction
|
0.00%
0/13
|
8.3%
1/12 • Number of events 2
|
|
Renal and urinary disorders
Urinary hesitation
|
7.7%
1/13 • Number of events 2
|
0.00%
0/12
|
|
General disorders
Fatigue
|
7.7%
1/13 • Number of events 2
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Sedation
|
23.1%
3/13 • Number of events 3
|
0.00%
0/12
|
|
General disorders
Sweating
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Disturbing dreams
|
7.7%
1/13 • Number of events 4
|
8.3%
1/12 • Number of events 7
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place