Trial Outcomes & Findings for rTMS in Treatment Resistant Depression (NCT NCT02080507)
NCT ID: NCT02080507
Last Updated: 2017-05-30
Results Overview
The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. The MADRS-S instrument has nine questions, with an overall score ranging from 0 to 60 points. A higher score indicates greater depressive symptoms.
COMPLETED
NA
12 participants
Baseline, Week 6
2017-05-30
Participant Flow
Participants were recruited March 2014 through August 2015 from the Emory University Outpatient Psychiatry Department and the Atlanta community. Of the 16 participants who consented for participation, 12 began study treatment.
Participants taking psychotropic medications were required to be stable on a stable dose for at least six weeks.
Participant milestones
| Measure |
Active Neuronetics rTMS Stimulator
Participants in this group were randomized to receive active repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
|
Inactive Neuronetics rTMS Stimulator
Participants in this group were randomized to receive sham repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
7
|
|
Overall Study
COMPLETED
|
5
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
rTMS in Treatment Resistant Depression
Baseline characteristics by cohort
| Measure |
Active Neuronetics rTMS Stimulator
n=5 Participants
Participants in this group were randomized to receive active repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
|
Inactive Neuronetics rTMS Stimulator
n=7 Participants
Participants in this group were randomized to receive sham repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
|
Total
n=12 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
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 6The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. The MADRS-S instrument has nine questions, with an overall score ranging from 0 to 60 points. A higher score indicates greater depressive symptoms.
Outcome measures
| Measure |
Active Neuronetics rTMS Stimulator
n=5 Participants
Participants in this group were randomized to receive active repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
|
Inactive Neuronetics rTMS Stimulator
n=7 Participants
Participants in this group were randomized to receive sham repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
|
|---|---|---|
|
Depression Severity as Assessed by the Montgomery Åsberg Depression Rating Scale (MADRS) Score
Baseline
|
26.4 units on a scale
Standard Deviation 3.14
|
29.29 units on a scale
Standard Deviation 5.26
|
|
Depression Severity as Assessed by the Montgomery Åsberg Depression Rating Scale (MADRS) Score
Week 6
|
11.5 units on a scale
Standard Deviation 4.5
|
16.3 units on a scale
Standard Deviation 4.03
|
SECONDARY outcome
Timeframe: Baseline, Week 6The Q-Les-SF assesses the degree of enjoyment and satisfaction experienced by individuals in various areas of daily functioning. The minimum raw score is 14, and the maximum score is 70. Higher scores indicate better satisfaction with life domains (physical health, feelings, work, household duties, school/course work, leisure time activities, and social relations).
Outcome measures
| Measure |
Active Neuronetics rTMS Stimulator
n=5 Participants
Participants in this group were randomized to receive active repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
|
Inactive Neuronetics rTMS Stimulator
n=7 Participants
Participants in this group were randomized to receive sham repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
|
|---|---|---|
|
Quality of Life Assessed by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-Les-SF) Score
Baseline
|
37.14 units on a scale
Standard Deviation 7.61
|
31.63 units on a scale
Standard Deviation 15.41
|
|
Quality of Life Assessed by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-Les-SF) Score
Week 6
|
67.86 units on a scale
Standard Deviation 7.14
|
40.18 units on a scale
Standard Deviation .89
|
Adverse Events
Active Neuronetics rTMS Stimulator
Inactive Neuronetics rTMS Stimulator
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place