Trial Outcomes & Findings for ECT Pulse Amplitude and Medial Temporal Lobe Engagement (NCT NCT02999269)
NCT ID: NCT02999269
Last Updated: 2023-07-24
Results Overview
Hamilton Depression Rating Scale - 24 item. Scores range from 0 to 76 (higher scores indicate more depression severity)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
62 participants
Primary outcome timeframe
post-ECT Hamilton Depression Rating Scale -24 item. The time frame is 4 weeks after study initiation.
Results posted on
2023-07-24
Participant Flow
Participant milestones
| Measure |
600 mA Right Unilateral ECT
MECTA Spectrum 5000Q Amplitude
MECTA Spectrum 5000Q Amplitude: Current
|
700 mA Right Unilateral ECT
MECTA Spectrum 5000Q Amplitude
MECTA Spectrum 5000Q Amplitude: Current
|
800 mA Right Unilateral ECT
MECTA Spectrum 5000Q Amplitude
MECTA Spectrum 5000Q Amplitude: Current
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
16
|
15
|
16
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ECT Pulse Amplitude and Medial Temporal Lobe Engagement
Baseline characteristics by cohort
| Measure |
600 mA Right Unilateral ECT
n=16 Participants
MECTA Spectrum 5000Q Amplitude
MECTA Spectrum 5000Q Amplitude: Current
|
700 mA Right Unilateral ECT
n=15 Participants
MECTA Spectrum 5000Q Amplitude
MECTA Spectrum 5000Q Amplitude: Current
|
800 mA Right Unilateral ECT
n=16 Participants
MECTA Spectrum 5000Q Amplitude
MECTA Spectrum 5000Q Amplitude: Current
|
Total
n=47 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 8 • n=5 Participants
|
64 years
STANDARD_DEVIATION 7 • n=7 Participants
|
67 years
STANDARD_DEVIATION 10 • n=5 Participants
|
65 years
STANDARD_DEVIATION 8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
15 participants
n=7 Participants
|
16 participants
n=5 Participants
|
47 participants
n=4 Participants
|
|
Hamilton Depression Rating Scale 24 items
|
37.0 units on a scale
STANDARD_DEVIATION 7.8 • n=5 Participants
|
38.0 units on a scale
STANDARD_DEVIATION 7.5 • n=7 Participants
|
33.8 units on a scale
STANDARD_DEVIATION 6.7 • n=5 Participants
|
36.3 units on a scale
STANDARD_DEVIATION 7.3 • n=4 Participants
|
PRIMARY outcome
Timeframe: post-ECT Hamilton Depression Rating Scale -24 item. The time frame is 4 weeks after study initiation.Population: full longitudinal model with an unstructured repeated measures covariance matrix
Hamilton Depression Rating Scale - 24 item. Scores range from 0 to 76 (higher scores indicate more depression severity)
Outcome measures
| Measure |
600 mA Right Unilateral ECT
n=16 Participants
MECTA Spectrum 5000Q Amplitude
MECTA Spectrum 5000Q Amplitude: Current
|
700 mA Right Unilateral ECT
n=15 Participants
MECTA Spectrum 5000Q Amplitude
MECTA Spectrum 5000Q Amplitude: Current
|
800 mA Right Unilateral ECT
n=16 Participants
MECTA Spectrum 5000Q Amplitude
MECTA Spectrum 5000Q Amplitude: Current
|
|---|---|---|---|
|
Depression Severity
|
22.5 score on a scale
Standard Error 2.3
|
12.0 score on a scale
Standard Error 2.1
|
14.1 score on a scale
Standard Error 2.4
|
PRIMARY outcome
Timeframe: post-ECT Hopkins Verbal Learning Trial-Revised (percent retention score, range 0 - 100, higher is better). The time frame is 4 weeks after study initiation.Hopkins Verbal Learning Trial-Revised (percent retention score, range 0 - 100, higher is better)
Outcome measures
| Measure |
600 mA Right Unilateral ECT
n=16 Participants
MECTA Spectrum 5000Q Amplitude
MECTA Spectrum 5000Q Amplitude: Current
|
700 mA Right Unilateral ECT
n=15 Participants
MECTA Spectrum 5000Q Amplitude
MECTA Spectrum 5000Q Amplitude: Current
|
800 mA Right Unilateral ECT
n=16 Participants
MECTA Spectrum 5000Q Amplitude
MECTA Spectrum 5000Q Amplitude: Current
|
|---|---|---|---|
|
Cognition
|
57.3 score on a scale
Standard Error 10
|
68 score on a scale
Standard Error 9
|
62 score on a scale
Standard Error 10
|
Adverse Events
600 mA Right Unilateral ECT
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
700 mA Right Unilateral ECT
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
800 mA Right Unilateral ECT
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
600 mA Right Unilateral ECT
n=20 participants at risk
MECTA Spectrum 5000Q Amplitude
MECTA Spectrum 5000Q Amplitude: Current
|
700 mA Right Unilateral ECT
n=20 participants at risk
MECTA Spectrum 5000Q Amplitude
MECTA Spectrum 5000Q Amplitude: Current
|
800 mA Right Unilateral ECT
n=20 participants at risk
MECTA Spectrum 5000Q Amplitude
MECTA Spectrum 5000Q Amplitude: Current
|
|---|---|---|---|
|
Nervous system disorders
headache
|
25.0%
5/20 • Number of events 10 • Each subject was evaluated for adverse effects over the 4-week study protocol.
|
30.0%
6/20 • Number of events 17 • Each subject was evaluated for adverse effects over the 4-week study protocol.
|
30.0%
6/20 • Number of events 17 • Each subject was evaluated for adverse effects over the 4-week study protocol.
|
Additional Information
Dr. Chris Abbott, Division Chief Neuromodulaton, Department of Psychiatry
University of New Mexico
Phone: 505272223
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place