Trial Outcomes & Findings for rTMS for Depressed Teens: A Sham-Controlled Trial, Part 1 (NCT NCT01804270)
NCT ID: NCT01804270
Last Updated: 2022-01-19
Results Overview
The Children's Depression Rating Scale-Revised (CDRS-R) is a validated, 17-item, semi-structured clinician rating tool to assess severity of depression with subject and parental input for 14 of the 17 items.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
Within 5 days after Treatment 30 or Last Treatment
Results posted on
2022-01-19
Participant Flow
Participant milestones
| Measure |
Part 1 Active
Blinded, active repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation (rTMS): Active treatments with repetitive transcranial magnetic stimulation (rTMS) consists of treatment settings of 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.
|
Part 1 Sham
Blinded, sham repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation (rTMS): Active treatments with repetitive transcranial magnetic stimulation (rTMS) consists of treatment settings of 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
4
|
|
Overall Study
COMPLETED
|
1
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Part 1 Active
Blinded, active repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation (rTMS): Active treatments with repetitive transcranial magnetic stimulation (rTMS) consists of treatment settings of 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.
|
Part 1 Sham
Blinded, sham repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation (rTMS): Active treatments with repetitive transcranial magnetic stimulation (rTMS) consists of treatment settings of 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
rTMS for Depressed Teens: A Sham-Controlled Trial, Part 1
Baseline characteristics by cohort
| Measure |
Part 1 Active
n=2 Participants
Blinded, active repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation (rTMS): Active treatments with repetitive transcranial magnetic stimulation (rTMS) consists of treatment settings of 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.
|
Part 1 Sham
n=4 Participants
Blinded, sham repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation (rTMS): Active treatments with repetitive transcranial magnetic stimulation (rTMS) consists of treatment settings of 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.
|
Total
n=6 Participants
Total of all reporting groups
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|---|---|---|---|
|
Age, Continuous
|
15 years
STANDARD_DEVIATION 1.41 • n=5 Participants
|
17.25 years
STANDARD_DEVIATION 1.5 • n=7 Participants
|
16.5 years
STANDARD_DEVIATION 1.76 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 5 days after Treatment 30 or Last TreatmentPopulation: Terminated study. Data was not collected nor analyzed
The Children's Depression Rating Scale-Revised (CDRS-R) is a validated, 17-item, semi-structured clinician rating tool to assess severity of depression with subject and parental input for 14 of the 17 items.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Within 5 days after Treatment 30 or Last TreatmentPopulation: Terminated study. Data was not collected nor analyzed.
The Clinical Global Impression - Severity (CGI-S) is a standardized assessment utilizing a 7-point scale with which the clinician rates the severity of the subject's depressive illness at the time of assessment relative to the clinician's past experience with patients who have the same diagnosis.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Within 5 days after Treatment 30 or Last TreatmentPopulation: Terminated study. Data was not collected nor analyzed.
The Clinical Global Impression - Improvement (CGI-I) is a standardized assessment utilizing a 7-point scale with which the clinician rates the degree to which the severity of the subject's depressive illness has improved or worsened compared to baseline severity.
Outcome measures
Outcome data not reported
Adverse Events
Part 1 Active
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1 Sham
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1 Active
n=2 participants at risk
Blinded, active repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation (rTMS): Active treatments with repetitive transcranial magnetic stimulation (rTMS) consists of treatment settings of 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.
|
Part 1 Sham
n=4 participants at risk
Blinded, sham repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation (rTMS): Active treatments with repetitive transcranial magnetic stimulation (rTMS) consists of treatment settings of 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.
|
|---|---|---|
|
Psychiatric disorders
Suicide attempt
|
50.0%
1/2 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 6 months.
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 6 months.
|
Other adverse events
| Measure |
Part 1 Active
n=2 participants at risk
Blinded, active repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation (rTMS): Active treatments with repetitive transcranial magnetic stimulation (rTMS) consists of treatment settings of 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.
|
Part 1 Sham
n=4 participants at risk
Blinded, sham repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation (rTMS): Active treatments with repetitive transcranial magnetic stimulation (rTMS) consists of treatment settings of 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.
|
|---|---|---|
|
Nervous system disorders
Headaches
|
100.0%
2/2 • Number of events 15 • Adverse Events were collected from baseline to end of study, approximately 6 months.
|
0.00%
0/4 • Adverse Events were collected from baseline to end of study, approximately 6 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place