Sham-Controlled Rapid-Acting Neuromodulation for Depression

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of California, Davis

About this trial

The goal of this study is to learn whether 5 days of accelerated intermittent theta burst stimulation (iTBS), a rapid form of transcranial magnetic stimulation (TMS), which is a non-invasive procedure that uses magnetic fields to stimulate brain activity, works to treat depression in adults.

The main questions it aims to answer are:

* Does accelerated iTBS reduce depressive symptoms compared to sham (placebo) stimulation? * Are there measurable brain, biological, and digitally measured emotion changes associated with treatment response?

Participants will:

* Be randomly assigned to receive either active iTBS or sham stimulation * Receive 10 stimulation sessions per day for 5 consecutive days (total of 50 sessions) * Complete MRI brain scans and EEG recordings before and after treatment * Provide blood and saliva samples to measure biological markers * Complete depression rating scales and questionnaires at baseline, during treatment, and at follow-up visits * Use a secure mobile app to record brief facial and vocal samples during the 5-day treatment and at follow-up visits * Return for follow-up visits at 1 week and at 1, 3, 6, and 12 months after treatment

Eligibility criteria

Qualifiers

English speaking

Able to provide informed consent

18-65 years old

Meets MDD criteria per the Mini International Neuropsychiatric Interview (MINI)

Disqualifiers

Unable to consent (due to medical condition, acute psychosis, substance use, etc)

Use of benzodiazepines or medications that would interfere with TMS treatment as per PI discretion

Active substance use or severe substance use that in the opinion of the PI would interfere with study participation

Untreated, active psychosis

Trial design

Treatments tested in this trial

  • intermittent theta burst stimulation
  • Sham (No Treatment)

Treatment groups

264 Participants
are divided into 2 treatment groups