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Mindfulness Engaged Neurostimulation for Depression (MEND II)

Mindfulness Engaged Neurostimulation for Depression

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 to 65 Years
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 a type of magnetic brain stimulation called iTBS combined with digital mindfulness training. It is for people whose depression has not improved with medication. Researchers want to see if the treatment can improve thinking skills and ease depression symptoms.

Repetitive Transcranial Magnetic stimulation (rTMS) is an FDA-approved therapy for treatment resistant depression (TRD) that involves brief magnetic stimulation pulses on the dorsolateral prefrontal cortex (DLPFC) brain region. But studies of rTMS alone show remission rates of \~30%. Additionally, rTMS has not been shown to improve cognitive functioning that may be an independent factor predicting treatment success. This study will develop a novel multimodal treatment, which combines intermittent theta burst stimulation (iTBS) - a type of rTMS with digital mindfulness training to engage brain plasticity, enhance cognition and alleviate depression symptoms in individuals with TRD.

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

Eligibility

Who can join

  • Have a current episode of major depression as part of major depressive disorder, not bipolar disorder.
  • Have tried at least one antidepressant that did not work and meets the study’s treatment-history rules.
  • Have moderate to severe depression, with a score above 19 on the MADRS depression scale.
  • Have not started a new antidepressant treatment or increased treatment in the 4 weeks before screening.
  • Can understand the study and agree to take part.

Who can't join

  • Cannot understand the study and agree to take part.
  • Have an unstable medical condition.
  • Have a condition affecting the brain or nerves, or a history of a seizure disorder.
  • Show current suicidal behavior on the study’s suicide-risk scale.
  • Are pregnant or breastfeeding.
  • Have a psychotic disorder or current symptoms, such as seeing or hearing things that are not there.
  • Have an implant inside the skull, another medical device, or a condition that makes magnetic brain stimulation unsafe.
  • Cannot safely have an MRI scan, which uses magnets to take pictures inside the body.

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

Official eligibility criteria

Inclusion Criteria: * Diagnosis of major depressive episode (MDE, in accordance with the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5), in the context of unipolar major depressive disorder. * At least one failed antidepressant medication trial at level 3 in the Antidepressant -Treatment History Form: Short Form (ATHF-SF) classification. * Montgomery-Åsberg Depression Rating Scale (MADRS) Score \>19 (moderate - severe depression). * No increase or initiation of new antidepressant therapy in the four weeks prior to screening. * Demonstrated capacity to give informed consent. Exclusion Criteria: * Inability to provide informed consent. * Medically unstable patients. * Concomitant neurological disorder or a history of a seizure disorder. * Exhibiting current suicidal behavior rating on the Columbia Suicide Severity Rating Scale (C-SSRS) * Patients who are pregnant or breastfeeding. * Any psychotic disorder or current active psychotic symptoms. * Patients who have intracranial implants, other medical device or condition deemed unsafe for TMS. * Contraindication to MRI scanning.

Study sites (1)

CA