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Procedure

Mindfulness Neurostimulation for Depression (MEND Trial)

Phase 2
Recruiting
Led By Jyoti Mishra, PhD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Demonstrated capacity to give informed consent
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
Must not have
Any psychotic disorder or current active psychotic symptoms
Concomitant neurological disorder or a history of a seizure disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Summary

"This trial aims to develop a new treatment for treatment-resistant depression by combining a type of magnetic stimulation with digital mindfulness training to improve cognitive functioning and alleviate depression symptoms in individuals who have not responded to traditional therapies

Who is the study for?
This trial is for individuals with treatment-resistant depression, meaning they haven't gotten better with standard treatments. Participants should be able to undergo magnetic brain stimulation and engage in digital mindfulness training.
What is being tested?
The study tests a new approach combining intermittent theta burst stimulation (a form of rTMS) with digital mindfulness exercises aimed at improving brain function and reducing depression symptoms more effectively than current methods.
What are the potential side effects?
Possible side effects may include discomfort at the stimulation site, headache, lightheadedness, or seizures (very rare). Mindfulness training is generally safe but can sometimes cause emotional distress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I understand the details of the trial and can consent to participate.
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I have been diagnosed with a major depressive episode.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have a psychotic disorder or active symptoms.
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I have a neurological condition or a history of seizures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in EEG source localized pDMN alpha activity
Secondary outcome measures
Change in Flanker Inhibition
Change in Montgomery Åsberg Depression Rating Scale Scores (MADRS)
Change in Selective Attention
Other outcome measures
Change in Generalized Anxiety Disorder 7 item scale (GAD7)
Change in Mindful Attention Awareness Scale (MAAS)
Change in Patient Health Questionnaire 9 item scale (PHQ9)
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Medi2-TBSExperimental Treatment1 Intervention
This arm will receive a multimodal treatment with a digital mindfulness training focused on attention to breathing for up to 20 min session dose for up to 20 sessions combined with neuro-navigated iTBS type of rTMS (for 20 treatments over 4 weeks) targeting the left dorsolateral prefrontal cortex (DLPFC) brain region.
Group II: Medi1-TBSExperimental Treatment1 Intervention
This arm will receive a multimodal treatment with a digital mindfulness training focused on attention to breathing for up to 10 min session dose for up to 20 sessions combined with neuro-navigated iTBS type of rTMS (for 20 treatments over 4 weeks) targeting the left dorsolateral prefrontal cortex (DLPFC) brain region.
Group III: Medi3-TBSActive Control1 Intervention
This arm will receive a multimodal treatment with a digital mindfulness training focused on intermittent deep breathing for up to 10 min session dose for up to 20 sessions combined with neuro-navigated iTBS type of rTMS (for 20 treatments over 4 weeks) targeting the left dorsolateral prefrontal cortex (DLPFC) brain region.

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,157 Previous Clinical Trials
1,571,349 Total Patients Enrolled
33 Trials studying Depression
59,113 Patients Enrolled for Depression
Jyoti Mishra, PhDPrincipal InvestigatorUniversity of California, San Diego
4 Previous Clinical Trials
146 Total Patients Enrolled
2 Trials studying Depression
90 Patients Enrolled for Depression
~47 spots leftby Apr 2026
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