Status:
TERMINATED
iTBS in Refractory Pediatric Depression
Lead Sponsor:
Stanford University
Conditions:
Depression
Eligibility:
All Genders
12-21 years
Phase:
NA
Brief Summary
This work will mark the first step in understanding the neural targets for rTMS in youth with difficult to treat depressive symptoms, creating benchmarks for optimizing the safety and efficacy of rTMS...
Detailed Description
Problem Statement: Depression is a global health problem with limited novel and targeted solutions. Currently available interventions (medication and psychotherapy) have failed to provide adequate cli...
Eligibility Criteria
Inclusion
- 10 participants ages 12-21 years of age
- with at least moderate to severe depressive symptoms confirmed by the Children's Depression Rating Scale-Revised (CDRS-R\>40) or Hamilton Rating Scale for Depression (HRSD-17 ≥ 18)
- able to commit to protocol schedule and provide Informed consent by a legal guardian and assent by a youth participant
- have had at least one prior antidepressant treatment failure with adequate dose and duration
Exclusion
- prior neurological diagnosis (neurodevelopmental disorders, strokes/traumatic brain injuries, brain tumor, epilepsy)
- contraindications for TMS or MRI e.g. have any implanted metal
- unstable medical conditions
- acute suicide risk, defined as an attempt in past 6 months that required medical treatment, or history of ≥2 suicide attempts in the past 12 months, or has a clear cut plan for suicide
- pregnancy, suspected pregnancy or not on birth control if sexually active; 6) Inability to locate and quantify a motor threshold
- any factor that the PI determines to be reason for exclusion.
Key Trial Info
Start Date :
November 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 9 2019
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03845504
Start Date
November 19 2018
End Date
October 9 2019
Last Update
December 12 2023
Active Locations (1)
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1
Stanford University Pediatric Mood Disorders Program
Stanford, California, United States, 94305