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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 1 days

Treatment 20 days

Follow Up 30 days

Awards & highlights

No Placebo-Only Group

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.

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I have tried at least one antidepressant that didn't work for me.

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I haven't started or increased my antidepressant dose in the last month.

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 ~ 1 days0 visits

Treatment ~ 20 days20 visits

Follow Up ~ 30 days1 visit

Screening ~ 1 days

Treatment ~ 20 days

Follow Up ~30 days

This trial's timeline: 1 days for screening, 20 days for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in EEG source localized pDMN alpha activity

Secondary study objectives

Change in Flanker Inhibition

Change in Montgomery Åsberg Depression Rating Scale Scores (MADRS)

Change in Selective Attention

Other study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 6Eligibility criteria met