Pharmacologic Augmentation of TMS for Depression With D-serine
Recruiting · NCT06876129 · Interventional (participants receive a specific treatment) · Lead sponsor: Mclean Hospital
View the official record on ClinicalTrials.gov →Interventions studied
D-serinePlaceboTMS
What this trial is about
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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed across 1 US state.
- McLean Hospital - Belmont, Massachusetts, United States