Mindfulness Engaged Neurostimulation for Depression

Launched by UNIVERSITY OF CALIFORNIA, SAN DIEGO · Apr 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for people with treatment-resistant depression, which means their depression hasn't improved with standard medications. The trial combines a type of brain stimulation called intermittent theta burst stimulation (iTBS) with digital mindfulness training. This innovative method aims to not only reduce depression symptoms but also help improve thinking abilities and brain flexibility.

To be eligible for this study, participants must be diagnosed with major depression and have tried at least one other medication that didn't work. They should also have a moderate to severe level of depression as measured by a specific scale. It’s important that they haven't started any new antidepressant treatment in the month before joining the trial. Participants can expect to engage in a series of treatments that involve both brain stimulation and mindfulness exercises, all while being monitored by healthcare professionals. This study is currently recruiting participants aged 18 to 74, and both men and women can apply. If you're looking for new options to manage depression and meet the criteria, this trial might be a worthwhile opportunity to consider.

Gender

ALL

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.