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Device

Transcranial Magnetic Stimulation for Depression

Phase 2
Recruiting
Led By Daniel S Pine, M.D.
Research Sponsored by National Institute of Mental Health (NIMH)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weekly
Awards & highlights
No Placebo-Only Group

Summary

This trial tests if transcranial magnetic stimulation plus cognitive therapy helps teens with major depression that hasn't responded to standard treatments.

Who is the study for?
This trial is for teens aged 13-17 with Major Depressive Disorder (MDD) who haven't improved after trying at least two types of antidepressants and talk therapy. They must be in good health, able to follow the study plan, and under a psychiatrist's care. Teens can't join if they're pregnant, have metal implants near their head, are at high risk for seizures or have certain medical conditions.
What is being tested?
The trial tests whether Transcranial Magnetic Stimulation (TMS), combined with cognitive behavioral therapy (CBT), helps teens with treatment-resistant MDD. TMS uses magnetic pulses on the scalp to affect brain activity. Participants will receive multiple sessions over weeks while being monitored closely.
What are the potential side effects?
Possible side effects include discomfort at the coil site on the scalp, muscle twitching during treatment, headache, lightheadedness or tingling sensations. There may also be temporary changes in thinking or concentration immediately after sessions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of protocol
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of protocol for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse event rate
Clinician Depression Rating Scale
Treatment completion rate

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ActiveExperimental Treatment1 Intervention
TMS

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)Lead Sponsor
2,921 Previous Clinical Trials
2,742,779 Total Patients Enrolled
701 Trials studying Depression
261,028 Patients Enrolled for Depression
Daniel S Pine, M.D.Principal InvestigatorNational Institute of Mental Health (NIMH)
7 Previous Clinical Trials
8,408 Total Patients Enrolled
2 Trials studying Depression
4,188 Patients Enrolled for Depression

Media Library

Intermittent Theta Burst Repetitive Transcranial Magnetic Stimulation (iTBS) (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05652465 — Phase 2
Depression Clinical Trial 2023: Intermittent Theta Burst Repetitive Transcranial Magnetic Stimulation (iTBS) Highlights & Side Effects. Trial Name: NCT05652465 — Phase 2
Intermittent Theta Burst Repetitive Transcranial Magnetic Stimulation (iTBS) (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05652465 — Phase 2
Depression Research Study Groups: Active
~53 spots leftby Jan 2027
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