Trial Outcomes & Findings for The Antidepressive Effect of rTMS as add-on to ECT (NCT NCT02123485)
NCT ID: NCT02123485
Last Updated: 2021-02-23
Results Overview
The Hamilton (17 -item) Rating Scale for Depression is a clinician-administered assessement scale, that contains 17 items pertaining to symptoms of depression experienced over the past week. The total range is 0-52.Higher scores mean a worse outcomeRemission is defined by a Hamilton 17-item total score \< 8.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
7 weeks
Results posted on
2021-02-23
Participant Flow
Participant milestones
| Measure |
Right Prefrontal Low Frequency (1 hz) Repetitive Transcranial Magnetic Stimulation (rTMS)
Right prefrontal Low frequency (1 hz) repetitive transcranial magnetic stimulation, administered with 2 sessions each week
Low frequency (1 hz) rTMS, as add-on to ECT: Right prefrontal Low frequency (1 hz) repetitive transcranial magnetic stimulation as add-on to ECT.
|
Sham- Right Prefrontal Low Frequency (1 hz) Repetitive Transcranial Magnetic Stimulation (rTMS)
Sham right prefrontal rTMS 2 times a week
Sham-rTMS: Right prefrontal Low frequency (1 hz) sham-stimulation using af double blind placebo coil as add-on to ECT.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
17
|
|
Overall Study
COMPLETED
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Low Frequency Repetitive Transcranial Magnetic Stimulation (rTMS)
n=18 Participants
Right prefrontal Low frequency (1 hz) repetitive transcranial magnetic stimulation, administered with 2 sessions each week
Low frequency (1 hz) rTMS, as add-on to ECT: Right prefrontal Low frequency (1 hz) repetitive transcranial magnetic stimulation as add-on to ECT.
|
Sham-rTMS
n=17 Participants
Sham right prefrontal rTMS 2 times a week
Sham-rTMS: Right prefrontal Low frequency (1 hz) sham-stimulation using af double blind placebo coil as add-on to ECT.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50 years
n=18 Participants
|
47 years
n=17 Participants
|
49 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=18 Participants
|
12 Participants
n=17 Participants
|
25 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=18 Participants
|
5 Participants
n=17 Participants
|
10 Participants
n=35 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Denmark
|
18 participants
n=18 Participants
|
17 participants
n=17 Participants
|
35 participants
n=35 Participants
|
|
Hamilton depression scale score
Hamilton depression rating scale (17-item)
|
24 units on a scale
n=18 Participants
|
26 units on a scale
n=17 Participants
|
25 units on a scale
n=35 Participants
|
|
Hamilton depression scale score
Hamilton depression rating scale (6-item)
|
13 units on a scale
n=18 Participants
|
13 units on a scale
n=17 Participants
|
13 units on a scale
n=35 Participants
|
|
Hamilton depression scale score
Major Depression inventory
|
45 units on a scale
n=18 Participants
|
41 units on a scale
n=17 Participants
|
43 units on a scale
n=35 Participants
|
|
Number of patients with Severe depression
|
15 Participants
n=18 Participants
|
17 Participants
n=17 Participants
|
32 Participants
n=35 Participants
|
|
number of patients with bipolar depressive
|
1 Participants
n=18 Participants
|
6 Participants
n=17 Participants
|
7 Participants
n=35 Participants
|
|
number of patients with melancholic depression
|
16 Participants
n=18 Participants
|
13 Participants
n=17 Participants
|
29 Participants
n=35 Participants
|
|
number of patients with psychotic depression
|
2 Participants
n=18 Participants
|
3 Participants
n=17 Participants
|
5 Participants
n=35 Participants
|
|
Antidepressant drug treatment
|
18 Participants
n=18 Participants
|
16 Participants
n=17 Participants
|
34 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 7 weeksThe Hamilton (17 -item) Rating Scale for Depression is a clinician-administered assessement scale, that contains 17 items pertaining to symptoms of depression experienced over the past week. The total range is 0-52.Higher scores mean a worse outcomeRemission is defined by a Hamilton 17-item total score \< 8.
Outcome measures
| Measure |
Low Frequency rTMS
n=17 Participants
Right prefrontal Low frequency (1 hz) repetitive transcranial magnetic stimulation, administered with 2 sessions each week
Low frequency (1 hz) rTMS, as add-on to ECT: Right prefrontal Low frequency (1 hz) repetitive transcranial magnetic stimulation as add-on to ECT.
|
Sham-rTMS
n=17 Participants
Sham right prefrontal rTMS 2 times a week
Sham-rTMS: Right prefrontal Low frequency (1 hz) sham-stimulation using af double blind placebo coil as add-on to ECT.
|
|---|---|---|
|
Remission
|
7 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 7 weeksThe Hamilton (17 -item) Rating Scale for Depression is a clinician-administered assessement scale, that contains 17 items pertaining to symptoms of depression experienced over the past week. The total range is 0-52.Higher scores mean a worse outcome. Response is defined by a reduction in the Hamilton 17 item score of \>= 50%
Outcome measures
| Measure |
Low Frequency rTMS
n=17 Participants
Right prefrontal Low frequency (1 hz) repetitive transcranial magnetic stimulation, administered with 2 sessions each week
Low frequency (1 hz) rTMS, as add-on to ECT: Right prefrontal Low frequency (1 hz) repetitive transcranial magnetic stimulation as add-on to ECT.
|
Sham-rTMS
n=17 Participants
Sham right prefrontal rTMS 2 times a week
Sham-rTMS: Right prefrontal Low frequency (1 hz) sham-stimulation using af double blind placebo coil as add-on to ECT.
|
|---|---|---|
|
Response
|
11 Participants
|
13 Participants
|
Adverse Events
Low Frequency rTMS
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Sham-rTMS
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low Frequency rTMS
n=12 participants at risk
Right prefrontal Low frequency (1 hz) repetitive transcranial magnetic stimulation, administered with 2 sessions each week
Low frequency (1 hz) rTMS, as add-on to ECT: Right prefrontal Low frequency (1 hz) repetitive transcranial magnetic stimulation as add-on to ECT.
|
Sham-rTMS
n=14 participants at risk
Sham right prefrontal rTMS 2 times a week
Sham-rTMS: Right prefrontal Low frequency (1 hz) sham-stimulation using af double blind placebo coil as add-on to ECT.
|
|---|---|---|
|
Nervous system disorders
severe confusion
|
8.3%
1/12 • Number of events 1 • 7 weeks
All-Cause Mortality monitored/assessed in all participants who completed the study. Serious and Other adverse events were monitored/assessed in 26 participants (74% of the population).
|
0.00%
0/14 • 7 weeks
All-Cause Mortality monitored/assessed in all participants who completed the study. Serious and Other adverse events were monitored/assessed in 26 participants (74% of the population).
|
Other adverse events
| Measure |
Low Frequency rTMS
n=12 participants at risk
Right prefrontal Low frequency (1 hz) repetitive transcranial magnetic stimulation, administered with 2 sessions each week
Low frequency (1 hz) rTMS, as add-on to ECT: Right prefrontal Low frequency (1 hz) repetitive transcranial magnetic stimulation as add-on to ECT.
|
Sham-rTMS
n=14 participants at risk
Sham right prefrontal rTMS 2 times a week
Sham-rTMS: Right prefrontal Low frequency (1 hz) sham-stimulation using af double blind placebo coil as add-on to ECT.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
mild discomfort during treatment
|
16.7%
2/12 • Number of events 2 • 7 weeks
All-Cause Mortality monitored/assessed in all participants who completed the study. Serious and Other adverse events were monitored/assessed in 26 participants (74% of the population).
|
7.1%
1/14 • Number of events 1 • 7 weeks
All-Cause Mortality monitored/assessed in all participants who completed the study. Serious and Other adverse events were monitored/assessed in 26 participants (74% of the population).
|
|
Nervous system disorders
mild headache
|
33.3%
4/12 • Number of events 6 • 7 weeks
All-Cause Mortality monitored/assessed in all participants who completed the study. Serious and Other adverse events were monitored/assessed in 26 participants (74% of the population).
|
21.4%
3/14 • Number of events 4 • 7 weeks
All-Cause Mortality monitored/assessed in all participants who completed the study. Serious and Other adverse events were monitored/assessed in 26 participants (74% of the population).
|
Additional Information
Dr Poul Erik Buchholtz
Department of Affective Disorder, Aarhus University Hospital, Denmark
Phone: 21474299
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place