Adding D‑serine to TMS treatment for depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional trial tests whether the NMDA co‑agonist D‑serine given alongside repeated TMS sessions improves clinical outcomes in adults with major depressive disorder. Participants receive a course of TMS using intermittent theta-burst (iTBS) or an 18‑Hz protocol across approximately 30 sessions while taking D‑serine or a placebo, with clinical measures collected at admission, interim points, and discharge. Symptom outcomes are captured using McLean Hospital's Clinical Measurement Initiative (CMI) via validated questionnaires including the QIDS‑SR, PHQ‑9, and GAD‑7 entered into REDCap. Safety screening excludes people with seizure history, implanted metal/devices, significant substance use that raises seizure risk, pre-existing renal disease, pregnancy or breastfeeding, and those taking interacting medications.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Clinical diagnosis of MDD
* English-speaking
* Adults aged 18-80
* Must be able to swallow capsules

Relative contraindications/possible exclusion criteria:

* Containing any implanted metal or devices
* Current or previous seizure history
* Active substance use that may significantly alter the seizure threshold

Any further safety clearances, and outpatient consultation opinions that are necessitated based on the answers to the screening will be obtained prior to moving forward with the study, as an already established practice within the clinic practice. In addition, any relative contraindications will be further reviewed according to Rossi et al.'s most updated safety guidelines for TMS.

Exclusion Criteria:

* Patients with pre-existing renal disease
* Known allergy to D-serine, or with
* Patients taking medications with known drug-drug interactions
* Children
* Pregnant or breast-feeding women

The investigators will not include children because prior safety and dosing studies excluded children. Although considered safe for TMS, the investigators will not include pregnant or breast-feeding women on the basis of unknown safety profile of exogenous D-serine for these patients.

Where it's running

• McLean Hospital
  Belmont, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Joshua C Brown, MD, PhD
• Email: jbrown@mclean.harvard.edu
• Phone: 617-855-2944

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.