Trial Outcomes & Findings for Safety and Effectiveness of NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy in Depressed Adolescents (NCT NCT02586688)
NCT ID: NCT02586688
Last Updated: 2025-06-12
Results Overview
The Hamilton Rating Scale for Depression (HRSD), also called the Hamilton Depression Rating Scale (HDRS), sometimes also abbreviated as HAM-D, is a multiple-item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery.HAM-D-24 24-item Hamilton Depression Rating Scale; Lower score is better (76 to 0)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
112 participants
Primary outcome timeframe
6 weeks
Results posted on
2025-06-12
Participant Flow
Data regarding Phase 2 and phase 3 of the study is not available. Primary analyses for the phase 1 data showed the study didnt meet its primary end point and hence no further analyses was done.
Participant milestones
| Measure |
TMS Active
Blinded Active TMS coil (Phase I). Active NeuroStar® Transcranial Magnetic Stimulation (TMS)
Active NeuroStar® Transcranial Magnetic Stimulation (TMS): Compare active NeuroStar® coil with sham NeuroStar® coil.
|
TMS Sham
Blinded Sham TMS coil (Phase I) Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)
Sham NeuroStar® Transcranial Magnetic Stimulation (TMS): Compare active NeuroStar® coil with sham NeuroStar® coil.
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
58
|
|
Overall Study
COMPLETED
|
48
|
55
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
TMS Active
Blinded Active TMS coil (Phase I). Active NeuroStar® Transcranial Magnetic Stimulation (TMS)
Active NeuroStar® Transcranial Magnetic Stimulation (TMS): Compare active NeuroStar® coil with sham NeuroStar® coil.
|
TMS Sham
Blinded Sham TMS coil (Phase I) Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)
Sham NeuroStar® Transcranial Magnetic Stimulation (TMS): Compare active NeuroStar® coil with sham NeuroStar® coil.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Adverse Event
|
3
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
TMS Active Arm
n=48 Participants
Blinded Active TMS coil Active NeuroStar® Transcranial Magnetic Stimulation (TMS)
Active NeuroStar® Transcranial Magnetic Stimulation (TMS): Compare active NeuroStar® coil with sham NeuroStar® coil.
|
TMS Sham Arm
n=55 Participants
Blinded Sham TMS coil Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)
Sham NeuroStar® Transcranial Magnetic Stimulation (TMS): Compare active NeuroStar® coil with sham NeuroStar® coil.
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
27 Participants
n=48 Participants
|
35 Participants
n=55 Participants
|
62 Participants
n=103 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=48 Participants
|
20 Participants
n=55 Participants
|
41 Participants
n=103 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=48 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=103 Participants
|
|
Age, Continuous
|
17.6 years
STANDARD_DEVIATION 2.28 • n=48 Participants
|
17.2 years
STANDARD_DEVIATION 2.22 • n=55 Participants
|
17.4 years
STANDARD_DEVIATION 2.25 • n=103 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=48 Participants
|
37 Participants
n=55 Participants
|
67 Participants
n=103 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=48 Participants
|
18 Participants
n=55 Participants
|
36 Participants
n=103 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
48 participants
n=48 Participants
|
55 participants
n=55 Participants
|
103 participants
n=103 Participants
|
|
The Hamilton Rating Scale for Depression (HRSD)
|
28.8 units on a scale
STANDARD_DEVIATION 5.75 • n=48 Participants
|
29.5 units on a scale
STANDARD_DEVIATION 6.69 • n=55 Participants
|
29.15 units on a scale
STANDARD_DEVIATION 6.22 • n=103 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Open Label population not analyzed for primary treatment effect. Continued treatment for maintenance
The Hamilton Rating Scale for Depression (HRSD), also called the Hamilton Depression Rating Scale (HDRS), sometimes also abbreviated as HAM-D, is a multiple-item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery.HAM-D-24 24-item Hamilton Depression Rating Scale; Lower score is better (76 to 0)
Outcome measures
| Measure |
Phase I TMS Active
n=48 Participants
Blinded Active TMS coil (Phase I). Active NeuroStar® Transcranial Magnetic Stimulation (TMS)
Active NeuroStar® Transcranial Magnetic Stimulation (TMS): Compare active NeuroStar® coil with sham NeuroStar® coil.
|
Phase I TMS Sham
n=55 Participants
Blinded Sham TMS coil (Phase I) Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)
Sham NeuroStar® Transcranial Magnetic Stimulation (TMS): Compare active NeuroStar® coil with sham NeuroStar® coil.
|
|---|---|---|
|
Hamilton Depression Rating Scale-24(HAMD24) Total Score Change From Baseline Value.
|
-11.1 score on a scale
Standard Error 2.03
|
-10.6 score on a scale
Standard Error 2.00
|
Adverse Events
TMS Active Arm
Serious events: 3 serious events
Other events: 31 other events
Deaths: 0 deaths
TMS Sham Arm
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TMS Active Arm
n=54 participants at risk
Blinded Active TMS coil . Active NeuroStar® Transcranial Magnetic Stimulation (TMS)
Active NeuroStar® Transcranial Magnetic Stimulation (TMS): Compare active NeuroStar® coil with sham NeuroStar® coil.
|
TMS Sham Arm
n=58 participants at risk
Blinded Sham TMS coil Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)
Sham NeuroStar® Transcranial Magnetic Stimulation (TMS): Compare active NeuroStar® coil with sham NeuroStar® coil.
|
|---|---|---|
|
Psychiatric disorders
Suicide Attempt (classified as definitely not related to the study device)
|
1.9%
1/54 • Number of events 1 • 6 weeks
Summary of AEs during the first 6 weeks post randomization to active TMS vs Sham
|
0.00%
0/58 • 6 weeks
Summary of AEs during the first 6 weeks post randomization to active TMS vs Sham
|
|
Psychiatric disorders
Suicidal Ideation- not related to study device
|
1.9%
1/54 • Number of events 1 • 6 weeks
Summary of AEs during the first 6 weeks post randomization to active TMS vs Sham
|
1.7%
1/58 • Number of events 1 • 6 weeks
Summary of AEs during the first 6 weeks post randomization to active TMS vs Sham
|
|
Psychiatric disorders
Worsening Depression- classified as definitely not related to the study device
|
1.9%
1/54 • Number of events 1 • 6 weeks
Summary of AEs during the first 6 weeks post randomization to active TMS vs Sham
|
0.00%
0/58 • 6 weeks
Summary of AEs during the first 6 weeks post randomization to active TMS vs Sham
|
Other adverse events
| Measure |
TMS Active Arm
n=54 participants at risk
Blinded Active TMS coil . Active NeuroStar® Transcranial Magnetic Stimulation (TMS)
Active NeuroStar® Transcranial Magnetic Stimulation (TMS): Compare active NeuroStar® coil with sham NeuroStar® coil.
|
TMS Sham Arm
n=58 participants at risk
Blinded Sham TMS coil Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)
Sham NeuroStar® Transcranial Magnetic Stimulation (TMS): Compare active NeuroStar® coil with sham NeuroStar® coil.
|
|---|---|---|
|
Eye disorders
Eye Pain
|
5.6%
3/54 • Number of events 3 • 6 weeks
Summary of AEs during the first 6 weeks post randomization to active TMS vs Sham
|
0.00%
0/58 • 6 weeks
Summary of AEs during the first 6 weeks post randomization to active TMS vs Sham
|
|
Gastrointestinal disorders
Nausea
|
11.1%
6/54 • Number of events 6 • 6 weeks
Summary of AEs during the first 6 weeks post randomization to active TMS vs Sham
|
5.2%
3/58 • Number of events 3 • 6 weeks
Summary of AEs during the first 6 weeks post randomization to active TMS vs Sham
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
3/54 • Number of events 3 • 6 weeks
Summary of AEs during the first 6 weeks post randomization to active TMS vs Sham
|
3.4%
2/58 • Number of events 2 • 6 weeks
Summary of AEs during the first 6 weeks post randomization to active TMS vs Sham
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
5.6%
3/54 • Number of events 3 • 6 weeks
Summary of AEs during the first 6 weeks post randomization to active TMS vs Sham
|
5.2%
3/58 • Number of events 3 • 6 weeks
Summary of AEs during the first 6 weeks post randomization to active TMS vs Sham
|
|
Gastrointestinal disorders
Twitching Facial
|
7.4%
4/54 • Number of events 4 • 6 weeks
Summary of AEs during the first 6 weeks post randomization to active TMS vs Sham
|
1.7%
1/58 • Number of events 1 • 6 weeks
Summary of AEs during the first 6 weeks post randomization to active TMS vs Sham
|
|
Nervous system disorders
Headache
|
31.5%
17/54 • Number of events 17 • 6 weeks
Summary of AEs during the first 6 weeks post randomization to active TMS vs Sham
|
17.2%
10/58 • Number of events 10 • 6 weeks
Summary of AEs during the first 6 weeks post randomization to active TMS vs Sham
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place