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One-Day cTBS Over the Precuneus

One-Day cTBS Over the Precuneus (OcTOPUS)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests two types of TMS, a treatment that uses magnetic pulses on the brain, for adults whose depression has not improved enough after at least two antidepressant treatments. It compares 20 sessions given in one day with sham (fake) treatment to see whether depression improves after 4 weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older.
  • You can speak, read, and understand enough English to complete study tests and agree to join on your own.
  • A qualified doctor has confirmed that you have major depression.
  • Your depression has not improved enough after at least two adequate antidepressant treatments.
  • You score 10 or higher on the PHQ-9, a questionnaire about depression symptoms.

Who can't join

  • A study doctor finds that TMS may be unsafe for you. Examples include a past serious reaction to TMS, seizures, stroke, serious head injury, or brain surgery.
  • Safety concerns may also include metal in your head outside your mouth; an implanted device, such as a pacemaker, hearing implant, medical pump, or tube inside your heart; or permanent head or neck tattoos.
  • Other possible safety concerns include frequent or severe headaches, another brain condition, an illness that injured your brain, or epilepsy (a seizure disorder) in your family.
  • You currently use recreational drugs.
  • You are pregnant or might be pregnant.
  • A study doctor finds that your medicines, a recent medicine change, or stopping a medicine creates an unsafe risk, including seizures.
  • You have ever been diagnosed with bipolar I or II disorder, a schizophrenia-related disorder, or another main disorder involving loss of touch with reality.
  • You have suicidal thoughts with intent or a plan that needs immediate care, or another urgent safety concern the study cannot safely manage.

Simplified for readability. The official criteria below are what the study team uses.

Official 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. * 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.

Study sites (1)

MA