Trial Outcomes & Findings for Study of Repetitive Transcranial Magnetic Stimulation (rTMS) in Depressed Teens (NCT NCT01502033)

NCT ID: NCT01502033

Last Updated: 2016-04-22

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: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: 5 days of Treatment 30 or Last Treatment
• Results posted on: 2016-04-22

Participant Flow

10 participants recruited(and enrolled) from the Mayo Clinic Child and Adolescent Mood Disorders Clinic.

Participants were maintained on stable dosage of antidepressant medication for 4 weeks prior to enrollment and rTMS treatment.

Participant milestones

Measure	Transcranial Magnetic Stimulation Open-label course of 30 daily treatments with repetitive transcranial magnetic stimulation (rTMS) at 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. Transcranial Magnetic Stimulation
Overall Study STARTED	10
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Transcranial Magnetic Stimulation Open-label course of 30 daily treatments with repetitive transcranial magnetic stimulation (rTMS) at 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. Transcranial Magnetic Stimulation
Overall Study 1 participant had scalp discomfort	1
Overall Study 1 participant had worsening depression	1
Overall Study 1 participant went back to school	1

Baseline Characteristics

Study of Repetitive Transcranial Magnetic Stimulation (rTMS) in Depressed Teens

Baseline characteristics by cohort

Measure	Transcranial Magnetic Stimulation n=10 Participants Open-label course of 30 daily treatments with repetitive transcranial magnetic stimulation (rTMS) at 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. Transcranial Magnetic Stimulation
Age, Categorical <=18 years	10 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	15.9 years STANDARD_DEVIATION 1.1 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants
Children's Depression Rating Scale Revised	62.9 units on a scale STANDARD_DEVIATION 8.2 • n=5 Participants

PRIMARY outcome

Timeframe: 5 days of Treatment 30 or Last Treatment

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

Measure

Transcranial Magnetic Stimulation n=10 Participants Open-label course of 30 daily treatments with repetitive transcranial magnetic stimulation (rTMS) at 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. Transcranial Magnetic Stimulation

Children's Depression Rating Scale-Revised (CDRS-R) Post Treatment 30 or Last Treatment (in Cases of Early Withdrawal)

41.8 units on a scale Standard Deviation 13.2

SECONDARY outcome

Timeframe: Within 5 days of Treatment 30 or Last Treatment

The Clinical Global Impression - Severity (CGI-S) is a standardized assessment utilizing a 7-point scale with which the clinician rates severity of the subject's depressive illness at the time of assessment relative to the clinician's past experience with patients with the same diagnosis. Range of scale is 1-7 (1= normal, not ill at all; 7= among the most ill patients; larger number indicates greater severity of symptoms or worse outcome).

Outcome measures

Measure

Transcranial Magnetic Stimulation n=10 Participants Open-label course of 30 daily treatments with repetitive transcranial magnetic stimulation (rTMS) at 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. Transcranial Magnetic Stimulation

Clinical Global Impression - Severity (CGI-S) Post Treatment 30 or Last Treatment (in Cases of Early Withdrawal)

3.4 units on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: Within 5 days of 30 treatments or after last treatment in case of early withdrawal

The Clinical Global Impression - Improvement (CGI-I) is a standardized assessment utilizing a 7-point scale with which the clinician rates improvment of the subject's depressive illness at the time of assessment relative to the clinician's past experience with patients with the same diagnosis. Range of scale is 1-7 (1= very much improved, 7=very much worse) larger number indicates greater severity of symptoms or worse outcome).

Outcome measures

Measure

Transcranial Magnetic Stimulation n=10 Participants Open-label course of 30 daily treatments with repetitive transcranial magnetic stimulation (rTMS) at 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. Transcranial Magnetic Stimulation

The Clinical Global Impression - Improvement (CGI-I)

2.7 units on a scale Standard Deviation 1.1

Adverse Events

Open Label Active Treatment

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Open Label Active Treatment n=10 participants at risk All participants had unblinded treatment
Skin and subcutaneous tissue disorders scalp pain	10.0% 1/10 • Number of events 1
Psychiatric disorders Anxiety	10.0% 1/10 • Number of events 1
Psychiatric disorders Depression	10.0% 1/10 • Number of events 1

Additional Information

Dr. Paul Croarkin

Mayo Clinic

Phone: (507) 293-2557

Email: croarkin.paul@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place