Transcranial Magnetic Stimulation for Youth With Treatment-Resistant Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title: An Open Trial of Transcranial Magnetic Stimulation for Youth With Treatment-Resistant Major Depressive Disorder

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

• NCT number: NCT05652465
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Daniel S Pine, M.D.
• Phone: (301) 594-1318
• Email: daniel.pine@nih.gov
• Status: Recruiting
• Phase: Phase 2
• Start date: June 26, 2024
• Completion date: January 1, 2027