Trial Outcomes & Findings for Repetitive Transcranial Magnetic Stimulation for Adolescent Depression: Efficacy, Predictive Biomarkers, and Mechanisms (NCT NCT02611206)

Results Overview

The Children's Depression Rating Scale-Revised (CDRS-R) is a measure of depression severity in adolescents and children of ages 6 to 12. The measure is completed by a clinician based on interviews with the child/adolescent and their parent. The scale includes 17 symptom areas, each rated on a likert scale ranging from 1 to 5 or 7. Depression severity is indiciated by the CDRS-R raw summary score computed by adding the item responses. The summary score ranges from 17 to 113, with a higher score indicating more severe depression and worse outcome. Change in score for each participant was calculated by subtracting their post-rTMS score from their baseline score, such that a positive value indicates a decrease in score from pre to post-treatment.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

Baseline to post-treatment

Results posted on

2023-05-18

Participant Flow

Participant milestones

Participant milestones
Measure	Period 1: 80% of MT All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 80% of MT	Period 2: 100% of MT All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 100% of MT	Period 3: 120% of MT All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 120% of MT
Overall Study STARTED	7	3	14
Overall Study COMPLETED	3	3	8
Overall Study NOT COMPLETED	4	0	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Repetitive Transcranial Magnetic Stimulation for Adolescent Depression: Efficacy, Predictive Biomarkers, and Mechanisms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Period 1: 80% of MT n=3 Participants All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 80% of MT	Period 2: 100% of MT n=3 Participants All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 100% of MT	Period 3: 120% of MT n=8 Participants All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 120% of MT	Total n=14 Participants Total of all reporting groups
Age, Continuous	16.07 years STANDARD_DEVIATION 1.64 • n=5 Participants	17.10 years STANDARD_DEVIATION 1.43 • n=7 Participants	16.17 years STANDARD_DEVIATION 1.52 • n=5 Participants	16.3 years STANDARD_DEVIATION 1.47 • n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 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	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	11 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline to post-treatment

The Children's Depression Rating Scale-Revised (CDRS-R) is a measure of depression severity in adolescents and children of ages 6 to 12. The measure is completed by a clinician based on interviews with the child/adolescent and their parent. The scale includes 17 symptom areas, each rated on a likert scale ranging from 1 to 5 or 7. Depression severity is indiciated by the CDRS-R raw summary score computed by adding the item responses. The summary score ranges from 17 to 113, with a higher score indicating more severe depression and worse outcome. Change in score for each participant was calculated by subtracting their post-rTMS score from their baseline score, such that a positive value indicates a decrease in score from pre to post-treatment.

Outcome measures

Outcome measures
Measure	Period 1: 80% of MT n=3 Participants All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 80% of MT	Period 2: 100% of MT n=3 Participants All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 100% of MT	Period 3: 120% of MT n=8 Participants All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 120% of MT
Change in Score on Child Depression Rating Scale - Revised (CDRS-R)	12.33 score on a scale Standard Deviation 6.03	1.33 score on a scale Standard Deviation 3.79	22.13 score on a scale Standard Deviation 4.29

SECONDARY outcome

Timeframe: Baseline to post-treatment

The Beck Depression Inventory (BDI-II) is a 21-item self-report measure of depression severity in adolescents and adults. Each item is measured on a likert scale ranging from 0 to 3. A total score is calculated by adding item responses and can range from 0 to 63, with a higher score indicating more severe depression and worse outcome. Change in score for each participant was calculated by subtracting their post-rTMS score from their baseline score, such that a positive value indicates a decrease in score from pre to post-treatment.

Outcome measures

Outcome measures
Measure	Period 1: 80% of MT n=3 Participants All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 80% of MT	Period 2: 100% of MT n=3 Participants All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 100% of MT	Period 3: 120% of MT n=8 Participants All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 120% of MT
Change in Score Beck Depression Inventory (BDI-II)	12.33 units on a scale Standard Deviation 11.02	7.33 units on a scale Standard Deviation 5.69	10.38 units on a scale Standard Deviation 9.26

SECONDARY outcome

Timeframe: Baseline to post-treatment

Columbia Suicide Severity Rating Scale (C-SSRS- recent version) is a 10-item measure of suicidal ideation and behavior. Participants were assigned a score between 0 and 8, with higher scores indicating the endorsement of more severe suicidal ideation or behavior (a worse outcome) and a score of "0" indicating no suicidal ideation or behavior (better outcome). Change in score for each participant was calculated by subtracting their post-rTMS score from their baseline score, such that a positive value indicates a decrease in score from pre to post-treatment.

Outcome measures

Outcome measures
Measure	Period 1: 80% of MT n=3 Participants All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 80% of MT	Period 2: 100% of MT n=3 Participants All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 100% of MT	Period 3: 120% of MT n=8 Participants All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 120% of MT
Change is Score Columbia Suicide Severity Rating Scale (C-SSRS)	4.33 units on a scale Standard Deviation 4.04	0.33 units on a scale Standard Deviation 0.58	3.38 units on a scale Standard Deviation 3.16

SECONDARY outcome

Timeframe: Baseline to post-treatment

The Temporal Experience of Pleasure Scale (TEPS) is an 18-item self-report measure of the tendency to anticipate and experience pleasure. Each item is rated on a likert scale ranging from 1 (very false for me) to 6 (very true for me). A total score is calculated by adding item responses and ranges from 18 to 108, such that higher scores indicate greater anticipation and experience of pleasure and better outcome. Change in score for each participant was calculated by subtracting their post-rTMS score from their baseline score, such that a positive value indicates a decrease in score from pre to post-treatment.

Outcome measures

Outcome measures
Measure	Period 1: 80% of MT n=3 Participants All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 80% of MT	Period 2: 100% of MT n=2 Participants All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 100% of MT	Period 3: 120% of MT n=8 Participants All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 120% of MT
Change in Score Temporal Experience of Pleasure Scale (TEPS)	-3 units on a scale Standard Deviation 17.06	2.5 units on a scale Standard Deviation 21.92	0.75 units on a scale Standard Deviation 13.21

SECONDARY outcome

Timeframe: Baseline to post-treatment

64-item measure of mood and anxiety disorder symptoms. Each item is rated on a likert scale ranging from 1 (not at all) to 5 (extremely). The measure includes 2 broad subscales of general depresson (20 items; score range: 20-100) and dysphoria (10 items; score range: 10-50) as well as 10 specific symptom scales: Lassitude (6 items; score range: 6-30), Insomnia (6 items; score range: 6-30), Suicidality (6 items; score range: 6-30), Well-Being (8 items; score range: 8-40), Social Anxiety (5 items; score range: 5-25), Appetite Loss (3 items; score range: 3-15), Appetite Gain (3 items; score range: 3-15), Ill Temper (5 items; score range: 5-25), Panic (8 items; score range: 8-40), and Traumatic Intrusions (4 items; score range: 4-20). Subscale scores are calculated by adding responses for items corresponding to the subscale, with higher scores on each subscale except the well-being subscale indicating poorer outcomes. Higher scores on well-being subscale indicates better outcome.

Outcome measures

Outcome measures
Measure	Period 1: 80% of MT n=3 Participants All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 80% of MT	Period 2: 100% of MT n=2 Participants All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 100% of MT	Period 3: 120% of MT n=6 Participants All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 120% of MT
Change in Score Inventory of Depression and Anxiety Symptoms (IDAS) Subscale: General Depression	7.67 units on a scale Standard Deviation 9.29	1.5 units on a scale Standard Deviation 16.26	17.67 units on a scale Standard Deviation 13.66

SECONDARY outcome

Timeframe: Baseline to post-treatment

The Young Mania Rating Scale is a 11-item measure of manic symptoms. Some items are rated on a likert scale ranging from 0 to 4 and some items are rated on a scale ranging from 0 to 8. Total scores range from 0 to 60, with a higher score indiciating higher levels of mania and worse outcome. Change in score for each participant was calculated by subtracting their post-rTMS score from their baseline score, such that a positive value indicates a decrease in score from pre to post-treatment.