Transcranial Magnetic Stimulation for Youth With Treatment-Resistant Major Depressive Disorder
- Conditions
- Major Depressive Disorder
- Interventions
- Device: Intermittent theta burst repetitive transcranial magnetic stimulation (iTBS)
- Registration Number
- NCT05652465
- Lead Sponsor
- National Institute of Mental Health (NIMH)
- Brief Summary
Background:
Major depressive disorder (MDD) is one of the most impairing medical conditions in the world. Medication and some kinds of talk therapy are standard treatments for teens with MDD, but these do not work well for everyone. Transcranial magnetic stimulation (TMS) has been approved to treat MDD in adults. TMS might help adolescents, too.
Objective:
To test TMS combined with cognitive behavioral therapy (CBT) in teens with MDD.
Eligibility:
People aged 13 to 17 years with MDD that has not responded to treatment.
Design:
Participants will be screened. They will have a physical exam and psychiatric evaluation. They will have an MRI scan and a test of their heart function. They will enroll in 2 NIH protocols (01-M-0254 and 18-M-0037).
For 2 to 6 weeks, participants will have weekly CBT, a kind of talk therapy. They will taper off of their psychiatric medicines.
For 2 weeks, participants will come to the clinic every weekday. They will receive 3 or 4 sessions of TMS on each of those days. A wire coil will be held on their scalp. A brief electrical current in the coil creates a magnetic pulse that affects brain activity. They will receive 30 TMS pulses in 10-second bursts; these will be repeated 60 times in each 15-minute session. Participants may hear a click and feel a pulling sensation under the coil. They may feel their muscles twitch. Each day, they will have tests of concentration, thinking, and memory. Some may have a 3rd week of TMS.
Participants will remain in the study for 5 more weeks. They will begin taking their medications again.
- Detailed Description
Study Description:
This is a safety and pilot efficacy study of open, neuronavigated intermittent theta burst stimulation (iTBS), a form of repetitive transcranial magnetic stimulation (rTMS) in medication-free youth with treatment-resistant major depression. The hypothesis is that intermittent theta burst TMS is a safe and potentially effective treatment for treatment-resistant major depression in adolescents.
Objectives:
The study has two objectives: 1) To evaluate safety, feasibility, and potential efficacy of iTBS in medication-free youth with the goal of supporting a future randomized controlled trial in youth with treatment-resistant major depression; 2) To assess changes in levels of psychiatric symptoms and brain imaging parameters after iTBS in youth with treatment-resistant major depression.
Endpoints:
Primary Endpoints:
Children s Depression Rating Scale (CDRS); rates of treatment completion and adverse events on standard rating scales
Secondary Endpoints:
1. Clinical Global Impression Improvement Scale (CGI-I)
2. Mood and Feelings Questionnaire (MFQ)
3. Screen for Child Anxiety Related Disorders (SCARED)
4. Resting state fMRI correlations across brain regions
5. Task-based fMRI activation to cognitive conflict
6. Fractional anisotropy on diffusion tensor imaging
7. Neurochemicals assessed by magnetic resonance spectroscopy
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Active Intermittent theta burst repetitive transcranial magnetic stimulation (iTBS) TMS
- Primary Outcome Measures
Name Time Method Clinician Depression Rating Scale Weekly Clinician-rated report
Treatment completion rate End of protocol Rate of participants completing 20 or more iTBS sessions
Adverse event rate Continuous Clinical rating on standardized scale
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States