Neuromodulation for Depression

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, San Diego

No Placebo Group

Trial Summary

What is the purpose of this trial?

This program of research constitutes a three-arm, randomized, placebo-controlled trial testing noninvasive brain stimulation for the treatment of anhedonic depression. This trial is part of a larger, three-site study that will be conducted at UCSD, Stanford University, and Cornell University, with the overarching goals to compare competing interventions tested at each site and to combine data that will allow for the creation of an end-to-end model of anhedonic depression. By doing this, the investigators hope to gain insight and lead to the development of brain-behavior biomarkers to identify who is best suited for the different treatment options tested at each site. An additional exploratory objective is phenotyping anhedonic depression from the acquired measures. Anhedonic patients recruited at UCSD will be randomized to one of three treatment arms to receive different forms of accelerated intermittent theta burst stimulation (aiTBS),a novel form of repetitive transcranial magnetic stimulation (rTMS) that is an FDA approved treatment for depression. These arms include: individualized accelerated iTBS (Ind-aiTBS),based on both the frequency of brain responses and electric-field (e-field) modeling of brain bioconductivity; standard accelerated iTBS (Std-aiTBS); and accelerated sham iTBS(sham). Treatment will be delivered on an accelerated schedule, over one week. Additional study sessions will occur both before and after treatment to assess for clinical, neurophysiological, and cognitive measures that will allow for both individualization of treatment and detailed assessment of the effects of the different treatment arms.

Research Team

Eligibility Criteria

This trial is for adults aged 18-80 with Major Depressive Disorder or Bipolar II, experiencing a major depressive episode and resistant to standard antidepressant treatments. Participants must be proficient in English, willing to follow the study procedures, have ongoing psychiatric care, and agree not to change their stable antidepressant regimen during the study. Pregnant individuals or those with certain mental health conditions, substance abuse issues, or contraindications for rTMS or MRI are excluded.

Inclusion Criteria

I am between 18 and 80 years old.

Able to read, understand, and provide written, dated informed consent prior to screening

I have been on a stable antidepressant regimen for 6 weeks and will continue it during the study.

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Exclusion Criteria

I take more than 2 mg/day of lorazepam or a similar medication.

I have a history of serious brain or nerve conditions.

My depression symptoms have not worsened by 30% or more recently.

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Treatment Details

Interventions

Individualized Accelerated Intermittent Theta Burst Stimulation (Ind-aiTBS) (Behavioural Intervention)
Sham Accelerated Intermittent Theta Burst Stimulation (Sham) (Behavioural Intervention)
Standard Accelerated Intermittent Theta Burst Stimulation (Std-aiTBS) (Behavioural Intervention)

Trial OverviewThe trial tests three forms of accelerated intermittent theta burst stimulation (aiTBS) on anhedonic depression: individualized aiTBS tailored by brain response frequency and bioconductivity modeling; standard aiTBS; and sham treatment as placebo. Delivered over one week at UCSD among other sites, it aims to develop biomarkers for tailoring treatment options.

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Individualized Accelerated Intermittent Theta Burst Stimulation (Ind-aiTBS)Experimental Treatment1 Intervention

Patients will receive individualized unilateral accelerated theta-burst stimulation to the left dorsal lateral prefrontal cortex for 5 consecutive days, with a total of 10 hours a day. Treatment will be 10min with 50min of breaks in between the 10 sessions. The target for stimulation will be individualized using the participant's fMRI scans by finding the region of the DLPFC most anti-correlated with the subgenual anterior cingulate cortex (sgACC). This target will be determined using e-field modeling and theta-gamma coupling.

Group II: Standard Accelerated Intermittent Theta Burst Stimulation (Std-aiTBS)Active Control1 Intervention

Patients will receive unilateral accelerated theta-burst stimulation to the left dorsal lateral prefrontal cortex for 5 consecutive days, with a total of 10 hours a day. Treatment will be 10min with 50min of breaks in between the 10 sessions.

Group III: Sham Accelerated Intermittent Theta Burst Stimulation (sham)Placebo Group1 Intervention

Patients will receive sham unilateral accelerated theta-burst stimulation to the left dorsal lateral prefrontal cortex for 5 consecutive days, with a total of 10 hours a day. Treatment will be 10min with 50min of breaks in between the 10 sessions.