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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
Ages 13-17 at the time of enrollment
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weekly
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 13 and 17 years old.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse event rate
Clinician Depression Rating Scale
Treatment completion rate

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
2,775 Previous Clinical Trials
2,673,664 Total Patients Enrolled
665 Trials studying Depression
251,338 Patients Enrolled for Depression
Daniel S Pine, M.D.Principal InvestigatorNational Institute of Mental Health (NIMH)
6 Previous Clinical Trials
8,258 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this study involve participants of 45 years or older?

"To meet the requirements for this trial, participants must be within the age bracket of 13 to 17. There are 196 trials available to minors and 973 specifically targeted towards seniors above 65."

Answered by AI

To what degree is Active a hazard to individuals receiving treatment?

"Our team has rated Active's safety as a 2 on the 1 to 3 scale since it is in Phase 2, which indicates that while there are some data supporting its safety, no research exists confirming its efficacy."

Answered by AI

Who is eligible to participate in this trial?

"This clinical trial is targeting 80 participants between the ages of 13 and 17 that have been diagnosed with major depressive disorder (MDD)."

Answered by AI

Are there any vacancies available for participants in this experiment?

"As indicated on clinicaltrials.gov, this specific medical trial is not presently recruiting study participants. The details of the experiment were initially uploaded December 20th 2022 and last revised December 14th 2022. Although there are no vacancies with this project at present, a plethora of other trials are seeking volunteers currently."

Answered by AI
~53 spots leftby Jan 2027