Trial Outcomes & Findings for Study of Neural Responses Induced by Antidepressant Effects (NCT NCT02674529)
NCT ID: NCT02674529
Last Updated: 2022-11-03
Results Overview
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. It was designed in 1979 by British and Swedish researchers as an adjunct to the Hamilton Rating Scale for Depression (HAMD) which would be more sensitive to the changes brought on by antidepressants and other forms of treatment than the Hamilton Scale was.\[2\] There is, however, a high degree of statistical correlation between scores on the two measures.
COMPLETED
PHASE2/PHASE3
60 participants
baseline and week 8
2022-11-03
Participant Flow
Six participants were excluded after enrollment for the following reasons: leaving the study site without informing study team, asking for extra-time to consider the study, feeling uncomfortable in the fMRI and asking to exit the scanner, testing positive for pregnancy tests, feeling indecisive, and not responding to contact attempts.
Participant milestones
| Measure |
Antidepressant Treatment
20mg of escitalopram will be taken over an 8-week period, starting with 10mg for the first week.
Escitalopram: Selective Serotonin Reuptake Inhibitor (SSRI)
|
Placebo
A placebo pill will be taken over an 8-week period.
Placebo: Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
29
|
|
Overall Study
COMPLETED
|
22
|
24
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
Antidepressant Treatment
20mg of escitalopram will be taken over an 8-week period, starting with 10mg for the first week.
Escitalopram: Selective Serotonin Reuptake Inhibitor (SSRI)
|
Placebo
A placebo pill will be taken over an 8-week period.
Placebo: Placebo
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Study of Neural Responses Induced by Antidepressant Effects
Baseline characteristics by cohort
| Measure |
Antidepressant Treatment
n=25 Participants
20mg of escitalopram will be taken over an 8-week period, starting with 10mg for the first week.
Escitalopram: Selective Serotonin Reuptake Inhibitor (SSRI)
|
Placebo
n=29 Participants
A placebo pill will be taken over an 8-week period.
Placebo: Placebo
|
Total
n=54 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
|
25 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
54 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
|
25.44 years
STANDARD_DEVIATION 6.33 • n=5 Participants
|
23.45 years
STANDARD_DEVIATION 5.65 • n=7 Participants
|
24.18 years
STANDARD_DEVIATION 5.76 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
29 participants
n=7 Participants
|
54 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and week 8Population: Scores can range from 0-60, with higher scores meaning greater the depression severity. The greater the change in MADRS scores from baseline, the better the outcome. 46 participants were analyzed, with 8 participants lost to follow up.
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. It was designed in 1979 by British and Swedish researchers as an adjunct to the Hamilton Rating Scale for Depression (HAMD) which would be more sensitive to the changes brought on by antidepressants and other forms of treatment than the Hamilton Scale was.\[2\] There is, however, a high degree of statistical correlation between scores on the two measures.
Outcome measures
| Measure |
Changes in MADRS Scores From Baseline to Week 8 Within the Antidepressant Treatment Arm
n=22 Participants
20mg of escitalopram will be taken over an 8-week period, starting with 10mg for the first week.
Escitalopram: Selective Serotonin Reuptake Inhibitor (SSRI)
|
Changes in MADRS Scores From Baseline to Week 8 Within the Placebo Arm
n=24 Participants
A placebo pill will be taken over an 8-week period.
Placebo: Placebo
|
|---|---|---|
|
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Scores
|
11 score on a scale
Standard Deviation 9
|
12 score on a scale
Standard Deviation 9
|
SECONDARY outcome
Timeframe: baseline and 8 weeksPopulation: Scores can range from 0-27, with higher scores meaning greater the depression severity. The greater the change in QIDS scores from baseline to week 8, the better the outcome. 46 participants were analyzed, with 8 participants lost to follow up.
The Quick Inventory of Depressive Symptomatology (QIDS) is a 16-item, self-reported measure of depression that ranges from 1 (no depression) to 27 (very severe depression).
Outcome measures
| Measure |
Changes in MADRS Scores From Baseline to Week 8 Within the Antidepressant Treatment Arm
n=22 Participants
20mg of escitalopram will be taken over an 8-week period, starting with 10mg for the first week.
Escitalopram: Selective Serotonin Reuptake Inhibitor (SSRI)
|
Changes in MADRS Scores From Baseline to Week 8 Within the Placebo Arm
n=24 Participants
A placebo pill will be taken over an 8-week period.
Placebo: Placebo
|
|---|---|---|
|
Change in Quick Inventory of Depressive Symptomatology (QIDS) Scores
|
6.82 score on a scale
Standard Deviation 6.01
|
5.54 score on a scale
Standard Deviation 5.45
|
SECONDARY outcome
Timeframe: BaselineVoxel-wise BOLD changes during the expectancy condition of the Sham Neurofeedback fMRI task.
Outcome measures
| Measure |
Changes in MADRS Scores From Baseline to Week 8 Within the Antidepressant Treatment Arm
n=54 Participants
20mg of escitalopram will be taken over an 8-week period, starting with 10mg for the first week.
Escitalopram: Selective Serotonin Reuptake Inhibitor (SSRI)
|
Changes in MADRS Scores From Baseline to Week 8 Within the Placebo Arm
A placebo pill will be taken over an 8-week period.
Placebo: Placebo
|
|---|---|---|
|
Neural Responses During the Sham Neurofeedback fMRI Task.
|
1.1 BOLD signal change
Interval 0.47 to 1.61
|
—
|
Adverse Events
Antidepressant Treatment
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Antidepressant Treatment
n=25 participants at risk
20mg of escitalopram will be taken over an 8-week period, starting with 10mg for the first week.
Escitalopram: Selective Serotonin Reuptake Inhibitor (SSRI)
|
Placebo
n=29 participants at risk
A placebo pill will be taken over an 8-week period.
Placebo: Placebo
|
|---|---|---|
|
Gastrointestinal disorders
Appetite Disturbances
|
24.0%
6/25 • Number of events 8 • Eight weeks.
|
3.4%
1/29 • Number of events 1 • Eight weeks.
|
|
Gastrointestinal disorders
Gastrointestinal Discomfort
|
12.0%
3/25 • Number of events 6 • Eight weeks.
|
6.9%
2/29 • Number of events 2 • Eight weeks.
|
|
Gastrointestinal disorders
Nausea
|
24.0%
6/25 • Number of events 9 • Eight weeks.
|
10.3%
3/29 • Number of events 7 • Eight weeks.
|
|
Gastrointestinal disorders
Weight Loss
|
4.0%
1/25 • Number of events 1 • Eight weeks.
|
0.00%
0/29 • Eight weeks.
|
|
Nervous system disorders
Dizziness
|
20.0%
5/25 • Number of events 5 • Eight weeks.
|
6.9%
2/29 • Number of events 2 • Eight weeks.
|
|
Nervous system disorders
Vivid Dreams/Nightmares
|
8.0%
2/25 • Number of events 4 • Eight weeks.
|
0.00%
0/29 • Eight weeks.
|
|
Nervous system disorders
Headache
|
12.0%
3/25 • Number of events 3 • Eight weeks.
|
6.9%
2/29 • Number of events 3 • Eight weeks.
|
|
Nervous system disorders
Worsening of Depressive Symptoms
|
8.0%
2/25 • Number of events 3 • Eight weeks.
|
3.4%
1/29 • Number of events 1 • Eight weeks.
|
|
Nervous system disorders
Anxiety
|
8.0%
2/25 • Number of events 2 • Eight weeks.
|
10.3%
3/29 • Number of events 6 • Eight weeks.
|
|
Nervous system disorders
Distractibility
|
0.00%
0/25 • Eight weeks.
|
3.4%
1/29 • Number of events 1 • Eight weeks.
|
|
Nervous system disorders
Hypomania
|
0.00%
0/25 • Eight weeks.
|
3.4%
1/29 • Number of events 1 • Eight weeks.
|
|
General disorders
Insomnia
|
12.0%
3/25 • Number of events 4 • Eight weeks.
|
17.2%
5/29 • Number of events 5 • Eight weeks.
|
|
General disorders
Fatigue
|
48.0%
12/25 • Number of events 31 • Eight weeks.
|
17.2%
5/29 • Number of events 6 • Eight weeks.
|
|
General disorders
Yawning
|
8.0%
2/25 • Number of events 2 • Eight weeks.
|
0.00%
0/29 • Eight weeks.
|
|
General disorders
Dry Mouth
|
4.0%
1/25 • Number of events 6 • Eight weeks.
|
0.00%
0/29 • Eight weeks.
|
|
General disorders
Increased Thirst
|
8.0%
2/25 • Number of events 7 • Eight weeks.
|
3.4%
1/29 • Number of events 3 • Eight weeks.
|
|
General disorders
Palpitations/Increased Heart Rate
|
4.0%
1/25 • Number of events 4 • Eight weeks.
|
3.4%
1/29 • Number of events 1 • Eight weeks.
|
|
General disorders
Sweating
|
4.0%
1/25 • Number of events 1 • Eight weeks.
|
0.00%
0/29 • Eight weeks.
|
|
General disorders
Sexual Dysfunction
|
8.0%
2/25 • Number of events 6 • Eight weeks.
|
0.00%
0/29 • Eight weeks.
|
|
General disorders
Urinary Urgency
|
0.00%
0/25 • Eight weeks.
|
6.9%
2/29 • Number of events 5 • Eight weeks.
|
|
Social circumstances
Leg Pain
|
4.0%
1/25 • Number of events 1 • Eight weeks.
|
0.00%
0/29 • Eight weeks.
|
|
Social circumstances
Cold/Sore Throat
|
4.0%
1/25 • Number of events 1 • Eight weeks.
|
3.4%
1/29 • Number of events 1 • Eight weeks.
|
|
Social circumstances
Broken Wrist
|
4.0%
1/25 • Number of events 2 • Eight weeks.
|
0.00%
0/29 • Eight weeks.
|
|
Social circumstances
Ovarian Cyst Rupture
|
4.0%
1/25 • Number of events 1 • Eight weeks.
|
0.00%
0/29 • Eight weeks.
|
|
Social circumstances
Food Poisoning
|
0.00%
0/25 • Eight weeks.
|
3.4%
1/29 • Number of events 1 • Eight weeks.
|
|
Social circumstances
Vision Issues
|
0.00%
0/25 • Eight weeks.
|
3.4%
1/29 • Number of events 2 • Eight weeks.
|
|
Social circumstances
Urinary Tract Infection
|
0.00%
0/25 • Eight weeks.
|
3.4%
1/29 • Number of events 1 • Eight weeks.
|
|
Social circumstances
Gonorrhea
|
0.00%
0/25 • Eight weeks.
|
3.4%
1/29 • Number of events 2 • Eight weeks.
|
|
Social circumstances
COVID-19
|
0.00%
0/25 • Eight weeks.
|
3.4%
1/29 • Number of events 2 • Eight weeks.
|
|
Social circumstances
Teeth Grinding/Jaw Clenching
|
0.00%
0/25 • Eight weeks.
|
3.4%
1/29 • Number of events 1 • Eight weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place