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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ end of protocol
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of protocol
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
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Who is running the clinical trial?
National Institute of Mental Health (NIMH)Lead Sponsor
2,913 Previous Clinical Trials
2,738,455 Total Patients Enrolled
699 Trials studying Depression
260,851 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Electroconvulsive therapy has never worked for me.I have previously undergone TMS therapy.I have a health condition that could affect the study.I have a history of epilepsy or seizures.My depression is caused by drug use or a health condition.I am between 13 and 17 years old.I have been diagnosed with a severe mental health condition like psychosis, bipolar disorder, or severe autism.I am in good health and can participate fully in the study.I have been diagnosed with an intellectual disability or have an IQ under 70.I am taking medication that could increase my risk of seizures.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Active
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