Trial Outcomes & Findings for Time to Remission of Depressive Symptoms With Combined SSRI and Ramelteon (NCT NCT00642694)
NCT ID: NCT00642694
Last Updated: 2019-07-26
Results Overview
Remission as defined by a score of \<12 on the Inventory of Depressive Symptomatology, Clinician-Rated version (IDS-C30) at Week 12; minimum possible score = 0, maximum possible score = 84; higher scores indicate worse symptom severity
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
29 participants
Primary outcome timeframe
12 Weeks
Results posted on
2019-07-26
Participant Flow
Participant milestones
| Measure |
Escitalopram + Ramelteon
active augmentation
|
Escitalopram + Placebo
Placebo augmentation
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
15
|
|
Overall Study
COMPLETED
|
8
|
11
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Time to Remission of Depressive Symptoms With Combined SSRI and Ramelteon
Baseline characteristics by cohort
| Measure |
Escitalopram + Ramelteon
n=14 Participants
active augmentation
|
Escitalopram + Placebo
n=15 Participants
Placebo augmentation
|
Total
n=29 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
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
42.6 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
42.0 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
42.3 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
15 participants
n=7 Participants
|
29 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 WeeksPopulation: Participants who were randomized to treatment and completed Week 12 were included in analyses
Remission as defined by a score of \<12 on the Inventory of Depressive Symptomatology, Clinician-Rated version (IDS-C30) at Week 12; minimum possible score = 0, maximum possible score = 84; higher scores indicate worse symptom severity
Outcome measures
| Measure |
Escitalopram + Ramelteon
n=10 Participants
active augmentation
|
Escitalopram + Placebo
n=11 Participants
control group
|
|---|---|---|
|
Percentage of Remitters on IDS-C30 at Week 12
|
20 percentage of participants
|
36 percentage of participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Number of Participants with analyzable data for this outcome measure
Number of minutes until fell asleep
Outcome measures
| Measure |
Escitalopram + Ramelteon
n=13 Participants
active augmentation
|
Escitalopram + Placebo
n=15 Participants
control group
|
|---|---|---|
|
Sleep Latency
|
30.4 minutes
Standard Deviation 29.1
|
15.8 minutes
Standard Deviation 16.2
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Please note that the study was terminated early and may be underpowered to perform these analyses; results should be interpreted with caution.
The Short-Form Health Survey - version 2 (SF-36) is a self-report inventory measuring different domains of health-related quality of life: Physical Functioning, Physical Role Functioning, Bodily Pain, General Health, Vitality, Social Functioning, Emotional Role Functioning, and Mental Health. Scores range from 0 to 100, with higher scores indicating better perceived health and functioning.
Outcome measures
| Measure |
Escitalopram + Ramelteon
n=14 Participants
active augmentation
|
Escitalopram + Placebo
n=15 Participants
control group
|
|---|---|---|
|
Short-Form Health Survey - Version 2 (SF-36)
Bodily Pain
|
75.31 score on a scale
Standard Deviation 25.93
|
87.96 score on a scale
Standard Deviation 19.22
|
|
Short-Form Health Survey - Version 2 (SF-36)
Physical Functioning
|
80.50 score on a scale
Standard Deviation 28.43
|
88.33 score on a scale
Standard Deviation 16.42
|
|
Short-Form Health Survey - Version 2 (SF-36)
Social Functioning
|
69.44 score on a scale
Standard Deviation 37.56
|
68.75 score on a scale
Standard Deviation 27.95
|
|
Short-Form Health Survey - Version 2 (SF-36)
Physical Role Functioning
|
75.00 score on a scale
Standard Deviation 28.93
|
86.11 score on a scale
Standard Deviation 17.89
|
|
Short-Form Health Survey - Version 2 (SF-36)
Emotional Role Functioning
|
67.59 score on a scale
Standard Deviation 24.45
|
75.00 score on a scale
Standard Deviation 20.10
|
|
Short-Form Health Survey - Version 2 (SF-36)
Mental Health
|
68.00 score on a scale
Standard Deviation 25.30
|
70.42 score on a scale
Standard Deviation 21.16
|
|
Short-Form Health Survey - Version 2 (SF-36)
Vitality
|
49.38 score on a scale
Standard Deviation 27.55
|
54.69 score on a scale
Standard Deviation 20.49
|
|
Short-Form Health Survey - Version 2 (SF-36)
General Health
|
74.90 score on a scale
Standard Deviation 21.12
|
79.25 score on a scale
Standard Deviation 20.23
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Please note that the study was terminated early and may be underpowered to perform these analyses; results should be interpreted with caution.
The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) measures satisfaction and enjoyment in various domains of functioning: physical health, feelings, work, household duties, school/course work, leisure time activities, social relations, and general activities. The raw score is converted into a percent of the maximum possible score and ranges from 0 to 100. Higher scores indicate greater enjoyment and satisfaction.
Outcome measures
| Measure |
Escitalopram + Ramelteon
n=14 Participants
active augmentation
|
Escitalopram + Placebo
n=15 Participants
control group
|
|---|---|---|
|
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
|
69.84 score on a scale
Standard Deviation 14.44
|
70.24 score on a scale
Standard Deviation 12.27
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Please note that the study was terminated early and may be underpowered to perform these analyses; results should be interpreted with caution.
The Social Adjustment Scale - Self-Report (SAS-SR) is a 54-item self-report measure of instrumental and expressive role performance. Each item is rated on a 5-point scale, and a mean item score (ranging from 1-5) is obtained, with higher scores indicating greater impairment.
Outcome measures
| Measure |
Escitalopram + Ramelteon
n=14 Participants
active augmentation
|
Escitalopram + Placebo
n=15 Participants
control group
|
|---|---|---|
|
Social Adjustment Scale - Self-Report (SAS-SR)
|
2.09 mean score on a scale
Standard Deviation 0.39
|
2.03 mean score on a scale
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Please note that the study was terminated early and may be underpowered to perform these analyses; results should be interpreted with caution.
The Work and Social Adjustment Scale (WSAS) is 5-item self-report measure designed to identify functional impairment that is attributed to an identified problem or condition. and has been used in studies of depression and anxiety. Scores range between 0-40, with higher scores indicating worse functioning.
Outcome measures
| Measure |
Escitalopram + Ramelteon
n=14 Participants
active augmentation
|
Escitalopram + Placebo
n=15 Participants
control group
|
|---|---|---|
|
Work and Social Adjustment Scale (WSAS)
|
15.56 score on a scale
Standard Deviation 11.42
|
13.91 score on a scale
Standard Deviation 12.89
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Please note that the study was terminated early and may be underpowered to perform these analyses; results should be interpreted with caution.
The Work Productivity and Activity Impairment Questionnaire (WPAI) was used to report impairment while working or performing usual daily activities as a result of health problems. The activity impairment item (#6 of WPAI) is rated on a scale of 0-10, with higher scores indicating greater impairment. Scores are multiplied by 10 to obtain percent impairment.
Outcome measures
| Measure |
Escitalopram + Ramelteon
n=14 Participants
active augmentation
|
Escitalopram + Placebo
n=15 Participants
control group
|
|---|---|---|
|
Work Productivity and Activity Impairment Questionnaire (WPAI)
|
40.00 percentage of time activity was impaired
Standard Deviation 35.36
|
32.50 percentage of time activity was impaired
Standard Deviation 27.34
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Please note that the study was terminated early and may be underpowered to perform these analyses; results should be interpreted with caution.
The Patient Perception of Benefits of Care (PPBC) assesses how much patients believe their quality of life will improve in response to medical care or treatment. Scores range between 10-50, with lower scores indicating greater belief that treatment will improve quality of life.
Outcome measures
| Measure |
Escitalopram + Ramelteon
n=14 Participants
active augmentation
|
Escitalopram + Placebo
n=15 Participants
control group
|
|---|---|---|
|
Patient Perception of Benefits of Care (PPBC)
|
20.33 score on a scale
Standard Deviation 8.38
|
20.08 score on a scale
Standard Deviation 12.50
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Please note that the study was terminated early and may be underpowered to perform these analyses; results should be interpreted with caution.
The Hamilton Rating Scale for Depression is a clinician-administered rating scale that assesses severity of depressive symptoms and is one of the most widely used and validated symptom severity measures for depression. Each of the 17 items is rated by the clinician on either a 3- or a 5 point scale. Total scores range from 0-52, with higher scores indicating greater depressive symptoms.
Outcome measures
| Measure |
Escitalopram + Ramelteon
n=14 Participants
active augmentation
|
Escitalopram + Placebo
n=15 Participants
control group
|
|---|---|---|
|
Hamilton Rating Scale for Depression 17-item
|
8.33 score on a scale
Standard Deviation 6.26
|
10.08 score on a scale
Standard Deviation 6.36
|
Adverse Events
Escitalopram + Ramelteon
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Escitalopram + Placebo
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Escitalopram + Ramelteon
n=14 participants at risk
active augmentation
|
Escitalopram + Placebo
n=15 participants at risk
Placebo augmentation
|
|---|---|---|
|
Gastrointestinal disorders
constipation
|
21.4%
3/14 • Number of events 5 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
13.3%
2/15 • Number of events 2 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
Nervous system disorders
vivid dreams
|
0.00%
0/14 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
6.7%
1/15 • Number of events 1 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
Reproductive system and breast disorders
pain and discomfort in genital area
|
0.00%
0/14 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
6.7%
1/15 • Number of events 1 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
Nervous system disorders
sinus headache
|
7.1%
1/14 • Number of events 1 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
6.7%
1/15 • Number of events 1 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
Cardiac disorders
palpitations
|
7.1%
1/14 • Number of events 1 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
13.3%
2/15 • Number of events 3 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
General disorders
tiredness
|
28.6%
4/14 • Number of events 12 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
6.7%
1/15 • Number of events 1 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
Nervous system disorders
insomnia
|
7.1%
1/14 • Number of events 1 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
0.00%
0/15 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
Gastrointestinal disorders
heartburn/indigestion/dyspepsia
|
7.1%
1/14 • Number of events 2 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
20.0%
3/15 • Number of events 3 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
Nervous system disorders
headache
|
50.0%
7/14 • Number of events 13 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
33.3%
5/15 • Number of events 15 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
Gastrointestinal disorders
dry mouth
|
14.3%
2/14 • Number of events 2 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
13.3%
2/15 • Number of events 10 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
Gastrointestinal disorders
stomach pain
|
7.1%
1/14 • Number of events 1 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
0.00%
0/15 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
Musculoskeletal and connective tissue disorders
muscle and joint aches and pains
|
35.7%
5/14 • Number of events 15 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
13.3%
2/15 • Number of events 2 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
Gastrointestinal disorders
increased appetite
|
7.1%
1/14 • Number of events 1 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
6.7%
1/15 • Number of events 1 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
Gastrointestinal disorders
weight gain
|
7.1%
1/14 • Number of events 1 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
0.00%
0/15 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
Nervous system disorders
metallic taste
|
7.1%
1/14 • Number of events 1 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
0.00%
0/15 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
Gastrointestinal disorders
nausea
|
14.3%
2/14 • Number of events 7 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
33.3%
5/15 • Number of events 5 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
Nervous system disorders
altered taste
|
7.1%
1/14 • Number of events 3 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
0.00%
0/15 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
Nervous system disorders
lightheadedness
|
7.1%
1/14 • Number of events 1 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
0.00%
0/15 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
Gastrointestinal disorders
diarrhea
|
28.6%
4/14 • Number of events 4 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
13.3%
2/15 • Number of events 3 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
Gastrointestinal disorders
toothache
|
0.00%
0/14 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
6.7%
1/15 • Number of events 1 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
Nervous system disorders
tingling
|
0.00%
0/14 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
6.7%
1/15 • Number of events 1 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
Nervous system disorders
head fullness
|
0.00%
0/14 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
6.7%
1/15 • Number of events 2 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
Nervous system disorders
fidgetiness/restlesness
|
7.1%
1/14 • Number of events 1 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
20.0%
3/15 • Number of events 12 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
Renal and urinary disorders
increased urination
|
7.1%
1/14 • Number of events 2 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
0.00%
0/15 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
Gastrointestinal disorders
stomach cramps
|
7.1%
1/14 • Number of events 4 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
0.00%
0/15 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
Blood and lymphatic system disorders
swollen lymph node
|
14.3%
2/14 • Number of events 4 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
0.00%
0/15 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
General disorders
increased yawning
|
0.00%
0/14 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
13.3%
2/15 • Number of events 5 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
Reproductive system and breast disorders
erectile dysfunction
|
14.3%
2/14 • Number of events 6 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
0.00%
0/15 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
General disorders
sinus infection/allergy
|
14.3%
2/14 • Number of events 3 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
0.00%
0/15 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
General disorders
increased perspiration
|
7.1%
1/14 • Number of events 1 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
0.00%
0/15 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
General disorders
dizziness
|
7.1%
1/14 • Number of events 1 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
0.00%
0/15 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
Skin and subcutaneous tissue disorders
rash
|
0.00%
0/14 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
13.3%
2/15 • Number of events 3 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
Reproductive system and breast disorders
decreased libido
|
0.00%
0/14 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
13.3%
2/15 • Number of events 6 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
Musculoskeletal and connective tissue disorders
pulled back muscle
|
0.00%
0/14 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
6.7%
1/15 • Number of events 1 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
Reproductive system and breast disorders
hot flashes
|
0.00%
0/14 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
6.7%
1/15 • Number of events 3 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
Eye disorders
blurred vision
|
0.00%
0/14 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
6.7%
1/15 • Number of events 1 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
Cardiac disorders
heart pounding
|
0.00%
0/14 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
6.7%
1/15 • Number of events 1 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
Psychiatric disorders
increased anxiety
|
7.1%
1/14 • Number of events 1 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
0.00%
0/15 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
Respiratory, thoracic and mediastinal disorders
sore throat
|
7.1%
1/14 • Number of events 1 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
0.00%
0/15 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
7.1%
1/14 • Number of events 1 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
0.00%
0/15 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
General disorders
chills
|
7.1%
1/14 • Number of events 1 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
0.00%
0/15 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
|
General disorders
fever
|
14.3%
2/14 • Number of events 2 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
0.00%
0/15 • During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
|
Additional Information
Dr.Prabha Sunderajan- Assistant Professor
UT Southwestern Medical Center
Phone: 214-645-6964
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place