Trial Outcomes & Findings for Emotional and Cognitive Control in Late-Onset Depression (NCT NCT01728194)
NCT ID: NCT01728194
Last Updated: 2020-10-06
Results Overview
Depression severity at baseline and week 12 in participants with MDD vs. controls, measured by score on the Montgomery Asberg Depression Rating Scale (MADRS). This measure is a clinical rating of mood with a score range from 0 to 60. Higher scores indicate greater depression severity.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
121 participants
Primary outcome timeframe
Baseline (Study Entry / Before Tx) and Week 12 (Following Tx)
Results posted on
2020-10-06
Participant Flow
Participant milestones
| Measure |
MDD (Escitalopram Tx)
Target dose 20mg for 12 weeks
Escitalopram: 20 mg target dose for 12 weeks
|
Control
No treatment (healthy comparison participants with no history or presence of psychiatric disorder)
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
67
|
|
Overall Study
COMPLETED
|
34
|
61
|
|
Overall Study
NOT COMPLETED
|
20
|
6
|
Reasons for withdrawal
| Measure |
MDD (Escitalopram Tx)
Target dose 20mg for 12 weeks
Escitalopram: 20 mg target dose for 12 weeks
|
Control
No treatment (healthy comparison participants with no history or presence of psychiatric disorder)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
|
Overall Study
Physician Decision
|
4
|
0
|
|
Overall Study
Withdrawal by Subject
|
7
|
3
|
|
Overall Study
Perceived Medication Side Effects
|
4
|
0
|
|
Overall Study
Family Member Request
|
1
|
0
|
Baseline Characteristics
Emotional and Cognitive Control in Late-Onset Depression
Baseline characteristics by cohort
| Measure |
MDD (Escitalopram Tx)
n=54 Participants
Target dose 20mg for 12 weeks
Escitalopram: 20 mg target dose for 12 weeks
|
Control
n=67 Participants
No treatment (healthy comparison participants with no history or presence of psychiatric disorder)
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
115 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
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
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
44 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Age, Continuous
|
71.76 years
STANDARD_DEVIATION 6.77 • n=5 Participants
|
72.36 years
STANDARD_DEVIATION 6.17 • n=7 Participants
|
72.09 years
STANDARD_DEVIATION 6.43 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
33 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
21 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
49 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
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 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
|
54 participants
n=5 Participants
|
67 participants
n=7 Participants
|
121 participants
n=5 Participants
|
|
Diagnostic Status
|
54 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Study Entry / Before Tx) and Week 12 (Following Tx)Population: 4 participants in the Escitalopram group and 4 participants in the Control group do not have follow-up MADRS data and have therefore been excluded from Week 12 analysis.
Depression severity at baseline and week 12 in participants with MDD vs. controls, measured by score on the Montgomery Asberg Depression Rating Scale (MADRS). This measure is a clinical rating of mood with a score range from 0 to 60. Higher scores indicate greater depression severity.
Outcome measures
| Measure |
Escitalopram
n=54 Participants
Patients diagnosed with MDD receiving 12-week Escitalopram intervention
|
Control
n=67 Participants
No Intervention / Non-psychiatric comparison participants
|
|---|---|---|
|
Change in Depression Severity (Measured by Montgomery Asberg Depression Rating Scale)
Baseline Depression Severity
|
25.26 score on a scale
Standard Deviation 4.65
|
1.03 score on a scale
Standard Deviation 1.36
|
|
Change in Depression Severity (Measured by Montgomery Asberg Depression Rating Scale)
Week 12 Depression Severity
|
13.78 score on a scale
Standard Deviation 9.07
|
1.08 score on a scale
Standard Deviation 1.43
|
SECONDARY outcome
Timeframe: Baseline (Study Entry / Before Tx) and Week 12 (Following Tx)Population: 4 participants in the Escitalopram group and 3 participants in the Control group do not have follow-up MADRS data and have therefore been excluded from Week 12 analysis.
Depression severity at baseline and week 12 in participants with MDD vs. controls, measured by score on the Hamilton Depression Rating Scale (HAM-D). This measure is a clinical rating of mood with a score range from 0 to 76. Higher scores indicate greater depression severity.
Outcome measures
| Measure |
Escitalopram
n=54 Participants
Patients diagnosed with MDD receiving 12-week Escitalopram intervention
|
Control
n=67 Participants
No Intervention / Non-psychiatric comparison participants
|
|---|---|---|
|
Change in Depression Severity (Measured by Hamilton Depression Rating Scale)
Baseline Depression Severity
|
23.48 score on a scale
Standard Deviation 4.45
|
1.24 score on a scale
Standard Deviation 1.32
|
|
Change in Depression Severity (Measured by Hamilton Depression Rating Scale)
Week 12 Depression Severity
|
12.44 score on a scale
Standard Deviation 8.49
|
1.52 score on a scale
Standard Deviation 1.69
|
Adverse Events
MDD (Escitalopram Tx)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Control
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MDD (Escitalopram Tx)
n=54 participants at risk
Target dose 20mg for 12 weeks
Escitalopram: 20 mg target dose for 12 weeks
|
Control
n=67 participants at risk
No treatment (healthy comparison participants with no history or presence of psychiatric disorder)
|
|---|---|---|
|
Surgical and medical procedures
Acute CVA
|
0.00%
0/54 • Baseline (Study Entry) through 12 Weeks of Treatment/Participation
|
1.5%
1/67 • Number of events 1 • Baseline (Study Entry) through 12 Weeks of Treatment/Participation
|
|
Surgical and medical procedures
Gallbladder removal
|
0.00%
0/54 • Baseline (Study Entry) through 12 Weeks of Treatment/Participation
|
1.5%
1/67 • Number of events 1 • Baseline (Study Entry) through 12 Weeks of Treatment/Participation
|
Other adverse events
| Measure |
MDD (Escitalopram Tx)
n=54 participants at risk
Target dose 20mg for 12 weeks
Escitalopram: 20 mg target dose for 12 weeks
|
Control
n=67 participants at risk
No treatment (healthy comparison participants with no history or presence of psychiatric disorder)
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
7.4%
4/54 • Number of events 5 • Baseline (Study Entry) through 12 Weeks of Treatment/Participation
|
4.5%
3/67 • Number of events 3 • Baseline (Study Entry) through 12 Weeks of Treatment/Participation
|
|
Skin and subcutaneous tissue disorders
Skin - Hives/Itchiness
|
1.9%
1/54 • Number of events 1 • Baseline (Study Entry) through 12 Weeks of Treatment/Participation
|
0.00%
0/67 • Baseline (Study Entry) through 12 Weeks of Treatment/Participation
|
|
Vascular disorders
Elevated BP
|
3.7%
2/54 • Number of events 2 • Baseline (Study Entry) through 12 Weeks of Treatment/Participation
|
0.00%
0/67 • Baseline (Study Entry) through 12 Weeks of Treatment/Participation
|
|
Psychiatric disorders
Fatigue + poor appetite
|
1.9%
1/54 • Number of events 1 • Baseline (Study Entry) through 12 Weeks of Treatment/Participation
|
0.00%
0/67 • Baseline (Study Entry) through 12 Weeks of Treatment/Participation
|
|
Psychiatric disorders
Low libido + low mood
|
1.9%
1/54 • Number of events 1 • Baseline (Study Entry) through 12 Weeks of Treatment/Participation
|
0.00%
0/67 • Baseline (Study Entry) through 12 Weeks of Treatment/Participation
|
Additional Information
Faith M. Gunning, PhD, Vice Chair for Research, Dept of Psychiatry
Well Cornell Medicine
Phone: 212-746-5832
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place