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Pharmacologic Augmentation of TMS for Depression With D-serine

RECRUITINGPhase 1Sponsored by Mclean Hospital
Actively Recruiting
PhasePhase 1
SponsorMclean Hospital
Started2025-04-01
Est. completion2026-02-01
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
Locations1 site

Summary

The goal of this study is to test whether combining D-serine with 30 treatments of a) iTBS and b) 18-Hz protocols will enhance clinical outcomes compared to rTMS with placebo (i.e., sugar pill). The investigators hypothesize that NMDA receptor activation via D-serine combined with repeated sessions of rTMS will produce greater clinical outcomes than iTBS with placebo and 18-Hz with placebo.

Eligibility

Age: 18 Years – 80 YearsHealthy volunteers accepted
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.

Conditions1

Depression

Locations1 site

McLean Hospital
Belmont, Massachusetts, 02478
Dennis Guevara617-855-2340dguevara@mclean.harvard.edu

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