RecruitingPhase 1NCT06876129

Pharmacologic Augmentation of TMS for Depression With D-serine

Sponsor

Mclean Hospital

Enrollment

60 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

Depression

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding D-serine — a naturally occurring amino acid — can boost the effectiveness of transcranial magnetic stimulation (TMS), a non-invasive brain stimulation treatment, for people with major depression. **You may be eligible if...** - You have been diagnosed with major depressive disorder (MDD) - You are between 18 and 80 years old - You can speak English - You are able to swallow capsules **You may NOT be eligible if...** - You have any metal implants or devices in your body - You have a current or past history of seizures - You have active substance use that could lower your seizure threshold Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETMS

Subjects will either receive iTBS using a Magventure TMS device or 18-Hz H1 TMS using a dTMS Brainsway device plus placebo.

DRUGD-serine

D-serine, 80 mg/kg, oral administration, will be advised to be taken 1-hour prior rTMS treatment day (Mon-Fri) for 6 weeks. Dosing is based on maximal plasticity at 80 mg/kg, and clinical dose-finding studies demonstrating that doses between 60 - 120 mg/kg were superior in clinical effectiveness to 30 mg/kg and were safe. Subjects will not be randomized into their TMS group and will either receive iTBS using a Magventure TMS device or 18-Hz H1 TMS using a dTMS Brainsway device. Subjects will have their TMS protocol/treatment determined at the time of consultation according to clinical appropriateness as is the standard of care at the TMS clinic at McLean Hospital.

OTHERPlacebo

The placebo is an inactive substance (e.g., lactose or cellulose) packaged to be identical in appearance, taste, and smell to the active study drug. Oral administration, will be advised to be taken 1-hour prior rTMS treatment day (Mon-Fri) for 6 weeks.