No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
69 (estimated)
Sponsor
Mclean Hospital · Other
Who this trial is looking for
This trial is looking for adults with treatment-resistant depression to see if a special brain stimulation treatment can help reduce their symptoms. Participants will receive either active treatment or a placebo and will attend one in-person visit for the procedure.
Are You a Good Fit for This Trial?
Rules you outBipolar I disorderBipolar II disorderSchizophrenia spectrum disorderPrimary psychotic disorder
You may be able to join if
I am 18 years old or older.
I can speak, read, and understand English well enough to take part.
I have been diagnosed with major depressive disorder.
I have treatment-resistant depression.
I have not responded well to at least two different antidepressant medications.
I have a score of 10 or higher on the PHQ-9 scale.
You may not be able to join if
I have a serious safety risk condition according to the study physician.
I have a history of seizure.
I have had a stroke.
I have had a serious head injury or brain surgery.
I have metal in my head that is not from dental work.
I have an implanted medical device.
I have current recreational drug use.
I am currently pregnant or might be pregnant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The goal of this clinical trial is to learn whether two forms of one-day accelerated transcranial magnetic stimulation (TMS) can reduce depressive symptoms in adults with treatment-resistant depression. Treatment-resistant depression is depression that has not improved enough after at least two adequate antidepressant medication treatments. TMS is a non-invasive treatment that uses magnetic pulses…
The goal of this clinical trial is to learn whether two forms of one-day accelerated transcranial magnetic stimulation (TMS) can reduce depressive symptoms in adults with treatment-resistant depression. Treatment-resistant depression is depression that has not improved enough after at least two adequate antidepressant medication treatments. TMS is a non-invasive treatment that uses magnetic pulses to stimulate specific areas of the brain.
The main questions this study aims to answer are:
* Does continuous theta-burst stimulation (cTBS) targeting the precuneus reduce depressive symptoms 4 weeks after treatment compared with sham stimulation?
* Does intermittent theta-burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex reduce depressive symptoms 4 weeks after treatment compared with sham stimulation?
Researchers will compare precuneus cTBS, left dorsolateral prefrontal cortex iTBS, and sham stimulation to determine whether either active treatment reduces depressive symptoms more than sham stimulation. Participants will be randomly assigned to one of the three groups and will not be told which treatment they initially receive.
Participants will:
* Complete screening procedures and baseline assessments of depression, rumination, and cognitive function
* Receive 20 sessions of active or sham TMS during one in-person study day
* Complete follow-up assessments 1, 2, 3, and 4 weeks after the intervention
* Report any side effects or medical problems experienced during the study
Participants initially assigned to sham stimulation may choose to receive active TMS after completing the 4-week follow-up period. Those who choose this option will receive either precuneus cTBS or left dorsolateral prefrontal cortex iTBS and will complete additional follow-up assessments.
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Eligibility Criteria
Inclusion Criteria:
* Age 18 years or older.
* Able to speak, read, and understand English sufficiently to complete the study assessments and provide informed consent independently.
* Diagnosis of major depressive disorder according to DSM-5-TR criteria, confirmed by a qualified physician.
* Treatm…
Inclusion Criteria:
* Age 18 years or older.
* Able to speak, read, and understand English sufficiently to complete the study assessments and provide informed consent independently.
* Diagnosis of major depressive disorder according to DSM-5-TR criteria, confirmed by a qualified physician.
* Treatment-resistant depression, defined as an inadequate response to at least two adequate trials of antidepressant pharmacotherapy.
* Patient Health Questionnaire-9 (PHQ-9) total score of 10 or higher.
Exclusion Criteria:
* Any condition identified through TMS safety screening that, in the judgment of a study physician, presents an unacceptable safety risk for TMS. Such conditions may include:
* A history of a serious adverse reaction during TMS treatment.
* A history of seizure.
* A history of stroke.
* A history of serious head injury or neurosurgery.
* Metal in the head outside the mouth, such as shrapnel, surgical clips, or metal fragments.
* An implanted device, such as a cardiac pacemaker, cochlear implant, medical pump, or intracardiac line.
* Frequent or severe headaches.
* Another brain-related condition or an illness that caused brain injury.
* A family history of epilepsy.
* Permanent tattoos on the head or neck.
* Current recreational drug use.
* Current pregnancy or possible pregnancy.
* Use of a medication or combination of medications, a recent medication change, or medication withdrawal that, in the judgment of a study physician, presents an unacceptable safety risk, including a clinically significant increase in seizure risk.
* Current or lifetime diagnosis of bipolar I disorder, bipolar II disorder, a schizophrenia spectrum disorder, or another primary psychotic disorder.
* Active suicidal ideation with intent or plan requiring immediate clinical intervention, or another acute safety concern that cannot be safely managed within the study.
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