Trial Outcomes & Findings for An Evaluation of Safety and Feasibility Using Repetitive Transcranial Magnetic Stimulation (rTMS) in Adolescents With Depression (NCT NCT00587639)

Results Overview

The Children's Auditory Verbal Learning Test 2 (CAVLT-2) is a neuropsychological test that measures auditory verbal learning and memory. This test is designed for ages 6.6-17.11 years. Scores are reported as normalized standard scores. The minimum standard score is 60 and the maximum 140; a higher score indicates a better performance.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

Pre-treatment (baseline visit) and post treatment (approximately 6-8 weeks after baseline visit)

Results posted on

2012-03-12

Participant Flow

Subjects were recruited from clinical and community referrals at 3 participating sites. The study took place from May 2007 to October 2009.

Participant milestones

Participant milestones
Measure	Active Treatment All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment)
Overall Study STARTED	8
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Active Treatment All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment)
Overall Study Withdrawal by Subject	1

Baseline Characteristics

An Evaluation of Safety and Feasibility Using Repetitive Transcranial Magnetic Stimulation (rTMS) in Adolescents With Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Treatment n=8 Participants All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment)
Age, Categorical <=18 years	8 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	16.5 years STANDARD_DEVIATION 1.18 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: Pre-treatment (baseline visit) and post treatment (approximately 6-8 weeks after baseline visit)

The Children's Auditory Verbal Learning Test 2 (CAVLT-2) is a neuropsychological test that measures auditory verbal learning and memory. This test is designed for ages 6.6-17.11 years. Scores are reported as normalized standard scores. The minimum standard score is 60 and the maximum 140; a higher score indicates a better performance.

Outcome measures

Outcome measures
Measure	rTMS Treatment n=7 Participants All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment)
Change in Cognitive Status as Measured by the Children's Auditory Verbal Learning Test 2 (CAVLT-2)	-11.3 units on a scale Standard Deviation 12.98

SECONDARY outcome

Timeframe: At study visit 30

The Children's Depression Rating Scale, Revised (CDRS-R) is a validated, 17-item, clinician rating tool to assess severity of depression. Parents provide input into 14 of the items. Scores range from 0 to 60, with the following scale: not depressed (\<20), borderline depressive symptoms (20-29), mild depression (30-39), moderate depression (40-59), severe depression (\>/=60).

Outcome measures

Outcome measures
Measure	rTMS Treatment n=7 Participants All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment)
Mean Level of Depression at Visit 30, as Measured by the Children's Depression Rating Scale, Revised (CDRS-R)	33.3 units on a scale Standard Deviation 7.3

Adverse Events

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

Other adverse events
Measure	Active Treatment n=8 participants at risk All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment)
Skin and subcutaneous tissue disorders Scalp Discomfort	37.5% 3/8 • Number of events 5 • Subjects were assessed for safety over the 6-8 weeks of treatment and at the 6- month follow-up assessment. Subjects were monitored for the possibility of headaches and scalp discomfort with a visual analog scale after each treatment.

Additional Information

Dr. Christopher Wall

Mayo Clinic

Phone: 5072843352

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place