Trial Outcomes & Findings for Magnetic Brain Stimulation for the Treatment of Adult Depression (NCT NCT00149838)
NCT ID: NCT00149838
Last Updated: 2018-12-28
Results Overview
The Hamilton Rating Scale for Depression 17-item total score ranges from 0 to 52 with higher scores indicating more depression. Remission is defined as a total score of ≤ 8
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
190 participants
Primary outcome timeframe
Measured at the end of Phases 1, 2, and 3
Results posted on
2018-12-28
Participant Flow
Participant milestones
| Measure |
Active TMS
Phase I participants receiving rTMS
Prefrontal Repetitive Transcranial Magnetic Stimulation (rTMS): Participants receive 120% motor threshold (MT) over left and right prefrontal cortex. Treatments will be administered daily for 3 weeks. Participants who show signs of improvement may continue Phase I for up to 3 additional weeks.
|
Sham TMS
Phase I participants receiving sham stimulation
Sham Stimulation: The sham stimulation will mimic the sensation of rTMS but will not induce an intracerebral current. Treatments will be administered daily for 3 weeks.
|
rTMS Extension
Phase II participants, all of whom did not meet remission requirements after phase 1. They will all receive active open label rTMS
|
Open Label Antidepressant Regimen
All patients who met remission who were then transitioned to medications after the TMS trial was completed.
|
|---|---|---|---|---|
|
Phase I
STARTED
|
92
|
98
|
0
|
0
|
|
Phase I
COMPLETED
|
72
|
82
|
0
|
0
|
|
Phase I
NOT COMPLETED
|
20
|
16
|
0
|
0
|
|
Phase II
STARTED
|
0
|
0
|
144
|
0
|
|
Phase II
COMPLETED
|
0
|
0
|
144
|
0
|
|
Phase II
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Phase III
STARTED
|
0
|
0
|
0
|
61
|
|
Phase III
COMPLETED
|
0
|
0
|
0
|
37
|
|
Phase III
NOT COMPLETED
|
0
|
0
|
0
|
24
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Magnetic Brain Stimulation for the Treatment of Adult Depression
Baseline characteristics by cohort
| Measure |
Active TMS
n=92 Participants
Phase I participants receiving rTMS
Prefrontal Repetitive Transcranial Magnetic Stimulation (rTMS): Participants receive 120% motor threshold (MT) over left and right prefrontal cortex. Treatments will be administered daily for 3 weeks. Participants who show signs of improvement may continue Phase I for up to 3 additional weeks.
|
Sham TMS
n=98 Participants
Phase I participants receiving sham stimulation
Sham Stimulation: The sham stimulation will mimic the sensation of rTMS but will not induce an intracerebral current. Treatments will be administered daily for 3 weeks.
|
Total
n=190 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.7 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
46.5 years
STANDARD_DEVIATION 12.3 • n=7 Participants
|
47.1 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at the end of Phases 1, 2, and 3Population: Remission
The Hamilton Rating Scale for Depression 17-item total score ranges from 0 to 52 with higher scores indicating more depression. Remission is defined as a total score of ≤ 8
Outcome measures
| Measure |
Active TMS
n=92 Participants
Phase I participants receiving rTMS
Prefrontal Repetitive Transcranial Magnetic Stimulation (rTMS): Participants receive 120% motor threshold (MT) over left and right prefrontal cortex. Treatments will be administered daily for 3 weeks. Participants who show signs of improvement may continue Phase I for up to 3 additional weeks.
|
Sham TMS
n=98 Participants
Phase I participants receiving sham stimulation
Sham Stimulation: The sham stimulation will mimic the sensation of rTMS but will not induce an intracerebral current. Treatments will be administered daily for 3 weeks.
|
Active Open for 3 Weeks
n=141 Participants
Phase II participants
Lower Dose rTMS: Participants who are unresponsive to Phase I treatment with rTMS will continue a lower dose of rTMS for an additional 3 to 7 weeks in Phase II.
|
Medication Followup
n=55 Participants
Phase III participants
Antidepressant Regimen: Particpants who acheive remission with rTMS may start antidepressant medication in phase III.
|
|---|---|---|---|---|
|
Depression Remission, as Measured by the Hamilton Rating Scale for Depression
|
13 number of remitted patients
|
5 number of remitted patients
|
43 number of remitted patients
|
12 number of remitted patients
|
Adverse Events
Active TMS
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Sham TMS
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
rTMS Extension
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Open Label Antidepressant Regimen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active TMS
n=92 participants at risk
Phase I participants receiving rTMS
Prefrontal Repetitive Transcranial Magnetic Stimulation (rTMS): Participants receive 120% motor threshold (MT) over left and right prefrontal cortex. Treatments will be administered daily for 3 weeks. Participants who show signs of improvement may continue Phase I for up to 3 additional weeks.
|
Sham TMS
n=98 participants at risk
Phase I participants receiving sham stimulation
Sham Stimulation: The sham stimulation will mimic the sensation of rTMS but will not induce an intracerebral current. Treatments will be administered daily for 3 weeks.
|
rTMS Extension
n=144 participants at risk
rTMS. Phase II participants, all of whom did not meet remission requirements after phase I. They all receive active open label rTMS
|
Open Label Antidepressant Regimen
n=61 participants at risk
All patients who met remission who were then transitioned to medications after the TMS trial was completed
|
|---|---|---|---|---|
|
Psychiatric disorders
All adverse events
|
19.6%
18/92 • Number of events 18
|
15.3%
15/98 • Number of events 15
|
0.00%
0/144
|
0.00%
0/61
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place