Trial Outcomes & Findings for iTBS in Refractory Pediatric Depression (NCT NCT03845504)
NCT ID: NCT03845504
Last Updated: 2023-12-12
Results Overview
Standardized assessment to determine depression severity. The CDRS-R total score is the sum of the responses to 17 questions. Each question is graded on a 5- or 7-point scale. Total score ranges from 17-113. In general, higher values of CDRS-R total score represent greater severity of illness. Response to treatment is determined by a ≥ 50% reduction in score from baseline to end of treatment.
TERMINATED
NA
4 participants
Baseline and week 6
2023-12-12
Participant Flow
4 participants were screened for eligibility, 2 were assigned to the study arm.
Participant milestones
| Measure |
Intermittent Theta Burst Stimulation
Daily open-label sessions delivered to left dorsolateral prefrontal cortex (DLPFC) over up to 6 weeks using the MagVenture MagPro repetitive transcranial magnetic stimulation (rTMS) Research System.
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
iTBS in Refractory Pediatric Depression
Baseline characteristics by cohort
| Measure |
Intermittent Theta Burst Stimulation
n=2 Participants
Daily open-label sessions delivered to left DLPFC over up to 6 weeks using the MagVenture MagPro rTMS Research System.
|
|---|---|
|
Age, Categorical
<=18 years
|
2 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
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and week 6Standardized assessment to determine depression severity. The CDRS-R total score is the sum of the responses to 17 questions. Each question is graded on a 5- or 7-point scale. Total score ranges from 17-113. In general, higher values of CDRS-R total score represent greater severity of illness. Response to treatment is determined by a ≥ 50% reduction in score from baseline to end of treatment.
Outcome measures
| Measure |
Intermittent Theta Burst Stimulation
n=2 Participants
Daily open-label sessions delivered to left DLPFC over up to 6 weeks using the MagVenture MagPro rTMS Research System.
|
|---|---|
|
Change in Children's Depression Rating Scale - Revised (CDRS-R) Score From
Baseline
|
73.0 score on a scale
Standard Deviation 0.0
|
|
Change in Children's Depression Rating Scale - Revised (CDRS-R) Score From
Change at week 6
|
-31.5 score on a scale
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: Baseline and week 6Standardized assessment to determine depression severity. HDRS-17, a clinician-rated measure of depressive symptoms that consists of 17 items rated using a semi-structured interview. Eight of the 17 HDRS-17 items are rated on a 5-point scale (0=absent; 1=doubtful or mild; 2=mild to moderate; 3=moderate to severe; 4=very severe), while the remaining 9 items are rated on a 3-point scale (0=absent; 1=doubtful or mild; 2=clearly present), yielding a minimum total score of 0 (least severe) and a maximum score of 52 (most severe). Response to treatment is determined by a ≥ 50% reduction in score from baseline to end of treatment.
Outcome measures
| Measure |
Intermittent Theta Burst Stimulation
n=2 Participants
Daily open-label sessions delivered to left DLPFC over up to 6 weeks using the MagVenture MagPro rTMS Research System.
|
|---|---|
|
Change in Hamilton Depression Rating Scale (HDRS-17)
Baseline
|
25.5 score on a scale
Standard Deviation 0.7
|
|
Change in Hamilton Depression Rating Scale (HDRS-17)
Change at week 6
|
-11.5 score on a scale
Standard Deviation 7.8
|
Adverse Events
Intermittent Theta Burst Stimulation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director, Research Development, Integrity and Strategy
Stanford University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place