Mindfulness and Brain Stimulation for Treatment Resistant Depression
Mindfulness Engaged Neurostimulation for Depression (MEND II)
Recruiting
Phase 2
Interventional Study
Depression
Treatment Resistant Depression
Major Depressive Disorder
Depressive Disorder
Depressive Symptoms
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 120 (estimated)
- Sponsor
- University of California, San Diego · Other
Who this trial is looking for
This trial is looking for people with major depression that hasn't improved with previous treatments. Participants will try a new combined approach of brain stimulation and mindfulness training to help reduce their depression symptoms.
Are You a Good Fit for This Trial?
You may be able to join if
- I have been diagnosed with a major depressive episode.
- I have tried at least one antidepressant medication that did not work.
- My depression score is above 19 on the MADRS scale.
- I have not started any new antidepressant therapy in the last four weeks.
- I can provide informed consent.
You may not be able to join if
- I cannot provide informed consent.
- I have unstable medical conditions.
- I have a neurological disorder or a history of seizures.
- I have current suicidal thoughts or behaviors.
- I am pregnant or breastfeeding.
- I have a psychotic disorder or active psychotic symptoms.
- I have any implants or medical devices that are unsafe for TMS.
- I cannot have an MRI.
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.
Check Your Eligibility
About This Trial
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…
Trial Locations
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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 Antidepre…
Contacts