Sham-Controlled Rapid-Acting Neuromodulation for Depression

Starting soon · Not applicable · Has a placebo group

Conditions studied: Depression - Major Depressive Disorder

In brief

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

Key facts

Study ID

NCT07487454

Run by

University of California, Davis

People needed

264

Starts

2026-12-01

Expected to finish

2028-05-01

Last updated by the study team

2026-06-16

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• English speaking
• Able to provide informed consent
• 18-65 years old
• Meets MDD criteria per the Mini International Neuropsychiatric Interview (MINI)

You may not qualify if…

• 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
• Female patient who is breastfeeding, pregnant or who is planning a pregnancy during the study
• Contraindications to receiving TMS and/or MRI as determined by screening questionnaires
• Participation in any clinical study with exposure to any investigational treatment or product within the previous 30 days, or plan on concurrent participation in other studies.

Where it is running

• UC Davis Medical Center — Sacramento, California, United States

Full record on ClinicalTrials.gov

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