Status:
RECRUITING
Pharmacologic Augmentation of TMS for Depression With D-serine
Lead Sponsor:
Mclean Hospital
Conditions:
Depression
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief 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 i...
Detailed Description
Consent Process: After referral from the clinician, subjects will be contacted either by phone, by email, or in person, advised of the opportunity to participate in this study, and informed about wha...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06876129
Start Date
April 1 2025
End Date
April 1 2026
Last Update
October 31 2025
Active Locations (1)
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1
McLean Hospital
Belmont, Massachusetts, United States, 02478