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Transcranial Magnetic Stimulation
Rapid-Acting TMS for Depression
N/A
Recruiting
Led By Alan F. Schatzberg, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Medical records confirming a history of moderate to severe treatment-resistance as defined by a score of 7-14 on the Maudsley Staging Method (MSM 3)
Currently diagnosed with Major Depressive Disorder (MDD) and meets criteria for a Major Depressive Episode, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5).
Must not have
History of significant neurologic disease, including dementia, Parkinson's or Huntington's disease, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma
Contraindication to receiving rTMS (e.g., metal in head, history of seizure, known brain lesion)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1-month.
Summary
This trial is testing if a new, accelerated schedule of transcranial magnetic stimulation (TMS) can help people with depression who haven't responded to other treatments. TMS is a non-invasive procedure that uses magnetic fields to stimulate nerve cells in the brain.
Who is the study for?
This trial is for adults aged 22-65 with Major Depressive Disorder who haven't responded well to other treatments. Participants must be in good health, not have certain mental health conditions or severe personality disorders, and can't be using substances or have metal implants that interfere with MRI scans.
What is being tested?
The study tests a rapid version of theta-burst stimulation (TBS) via transcranial magnetic stimulation (TMS) against a sham treatment for depression. It's randomized and double-blind, meaning neither the researchers nor participants know who gets real TBS until after the study.
What are the potential side effects?
While TMS is generally considered safe, it may cause discomfort at the site of stimulation, headache, lightheadedness, or seizures in rare cases. The sham treatment should have no side effects as it's designed to mimic TBS without delivering active treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My medical records show I have hard-to-treat depression.
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I have been diagnosed with Major Depressive Disorder.
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I have been diagnosed with Major Depressive Disorder.
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I have never undergone TMS therapy.
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I am between 22 and 65 years old.
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I have never undergone TMS therapy.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of serious brain or nerve conditions.
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I do not have metal implants in my head, a history of seizures, or known brain lesions.
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My depression symptoms have not worsened by 30% or more recently.
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My treatment's intensity is more than 65% of the maximum level.
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I've had more than 8 ECT sessions without improvement.
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I have a hormone-related condition that is untreated or not fully treated.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1-month.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1-month.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Rates of remission one month after treatment in the Montgomery-Åsberg Depression Rating Scale (MADRS) score.
Secondary study objectives
Rates of response one month after treatment in the Montgomery-Åsberg Depression Rating Scale (MADRS) score.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active TBS-DLPFCActive Control1 Intervention
The active group will receive theta-burst TMS stimulation.
Group II: Sham TBS-DLPFCPlacebo Group1 Intervention
The sham group will receive sham theta-burst TMS stimulation.
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,472 Previous Clinical Trials
17,501,718 Total Patients Enrolled
Alan F. Schatzberg, MDPrincipal InvestigatorStanford University
David Spiegel, MDPrincipal InvestigatorStanford University
11 Previous Clinical Trials
1,717 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your depression score is 20 or higher during the first visit of the study.I can get rTMS treatment after the study ends.I have a stable anxiety disorder but no other major psychiatric conditions needing treatment.You have received any experimental medications or treatments during the study timeframe.I have a history of serious brain or nerve conditions.I do not have metal implants in my head, a history of seizures, or known brain lesions.I can get rTMS treatment after the study ends.I have ongoing mental health support available before and after the study.I can speak and understand English well enough to follow study instructions and fill out questionnaires.My depression symptoms have not worsened by 30% or more recently.My treatment's intensity is more than 65% of the maximum level.My medical records show I have hard-to-treat depression.Do not drink alcohol for one day before each MRI and TMS session.I've had more than 8 ECT sessions without improvement.You can continue to drink coffee, tea, cola, and eat chocolate as you normally would during the study.You are currently struggling with a serious drug or alcohol problem or experiencing withdrawal symptoms.You have been diagnosed with a learning disability or autism.I have been diagnosed with Major Depressive Disorder.You have had thoughts of hurting yourself or have attempted suicide within the past year.I have a hormone-related condition that is untreated or not fully treated.I have been on a stable antidepressant regimen for 6 weeks and will continue it during the study.I have been diagnosed with Major Depressive Disorder.I have never undergone TMS therapy.You have a history of or currently have a mental health condition called psychosis or bipolar disorder.I am between 22 and 65 years old.I have never undergone TMS therapy.You have a severe form of borderline personality disorder.I have used ketamine or had ECT for depression within the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Active TBS-DLPFC
- Group 2: Sham TBS-DLPFC
Awards:
This trial has 0 awards, including: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.
Major Depressive Disorder Patient Testimony for trial: Trial Name: NCT04739969 — N/A
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