Trial Outcomes & Findings for rTMS for Depressed Teens: A Sham-Controlled Trial, Part 2 (NCT NCT01804296)

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

Target enrollment

4 participants

Primary outcome timeframe

Within 5 days after Treatment 30 or Last Treatment

Results posted on

2022-01-19

Participant Flow

Participant milestones

Participant milestones
Measure	Part 2 Active Open-label, 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.
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

rTMS for Depressed Teens: A Sham-Controlled Trial, Part 2

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 2 Active n=4 Participants Open-label, 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.
Age, Continuous	16.75 years STANDARD_DEVIATION 1.5 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 5 days after Treatment 30 or Last Treatment

Population: Terminated study. Data was not collected nor analyzed.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Within 5 days after Treatment 30 or Last Treatment

Population: 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 Treatment

Population: 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 2 Active

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part 2 Active n=4 participants at risk Open-label, 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.
Psychiatric disorders Suicide attempt	25.0% 1/4 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 6 months.

Other adverse events

Other adverse events
Measure	Part 2 Active n=4 participants at risk Open-label, 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.
Nervous system disorders Headache	75.0% 3/4 • Number of events 20 • Adverse Events were collected from baseline to end of study, approximately 6 months.

Additional Information

Paul E. Croarkin, D.O., M.S.

Mayo Clinic

Phone: 507-293-2557

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place