Clinical trial NCT06399406: Mindfulness Engaged Neurostimulation for Depression
Official title: Mindfulness Engaged Neurostimulation for Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Depression
Treatment Resistant Depression
Major Depressive Disorder
Depressive Disorder
Keywords: rTMS
mindfulness
depression
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This study aims to develop a novel multimodal treatment for treatment resistant depression (TRD), which combines intermittent theta burst stimulation (iTBS), a type of FDA-approved rTMS protocol, with digital mindfulness training. We propose that this multimodal treatment will suppress posterior Default Mode Network (pDMN) brain activity as measured with electroencephalography (primary outcome and neural target), as well as enhance cognition and alleviate depression symptoms in patients with TRD. The study will determine the optimal dose required for neural target engagement by the multimodal iTBS + digital mindfulness training relative to an active control training combined with iTBS.

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.

Primary outcomes:
measure: Change in EEG source localized pDMN alpha activity
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in Selective Attention
timeFrame: 4 weeks
measure: Change in Flanker Inhibition
timeFrame: 4 weeks
measure: Change in Montgomery Åsberg Depression Rating Scale Scores (MADRS)
timeFrame: 8 weeks
Other outcomes:
measure: Change in Working Memory
timeFrame: 4 weeks
measure: Change in Mindful Attention Awareness Scale (MAAS)
timeFrame: 4 weeks
measure: Change in Rumination Reflection Questionnaire (RRQ)
timeFrame: 4 weeks
measure: Change in Patient Health Questionnaire 9 item scale (PHQ9)
timeFrame: 8 weeks
measure: Change in Generalized Anxiety Disorder 7 item scale (GAD7)
timeFrame: 8 weeks
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Jyoti Mishra, PhD
role: PRINCIPAL_INVESTIGATOR
References: