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Detailed Description
The overall goal of this study is to evaluate the feasibility, safety, and preliminary efficacy of deep Transcranial Magnetic Stimulation (dTMS) as an adjunctive treatment for adolescents hospitalized with major depressive disorder (MDD). Our central hypotheses are that dTMS H7 targeting the dorsomedial prefrontal and cingulate cortices, delivered via the Brainsway H7-Coil™, will be safe, well tolerated, and lead to improved depressive symptoms, reduced suicide risk, and lower readmission rates compared to sham treatment. Investigators propose a double-blind, sham-controlled randomized clinical trial enrolling 14- to 18-year-old inpatients with MDD with or without obsessive compulsive disorder (OCD). Participants (n=60) will be randomized to receive either active or sham TMS during hospitalization, with follow-up assessments continuing for 12 months post-discharge. Outcomes will include safety, tolerability, treatment adherence, depressive symptom change, suicidal ideation, and time to psychiatric readmission. This study will provide foundational data to support the clinical integration of TMS into inpatient care for adolescents with treatment-resistant depression.
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Check your eligibility
Take up this questionnaire to help us determine if you have symptoms
that are common to this clinical study. If you have the common
symptoms, you may be eligible to take part in the study.
Age
14 - 18
Gender
All
NCT ID
NCT07217444
Phase
-1
Status
Recruiting Now
Medical Condition
Suicidal Ideation
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Medical Condition
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Learn moreThe Study
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Learn moreAbout Clinical Trials
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Learn moreYour Journey
01
Receiving the medication
You would receive etanercept (Enbrel) twice a week for 12 weeks and
then once a week for 12 weeks. Etanercept, as well as study related
medical care, is provided at no cost.
02
Visiting the study site
Study participation involves approximately 8 visits to your local
study center over 6 to 7 months.
03
Follow-up
There would also be a follow-up telephone call 30days after
completing the study. No visits are required after participation is
complete.