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RecruitingPhase 1

Pharmacologic Augmentation of TMS for Depression With D-serine

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Pills

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether adding D-serine to 30 treatments of TMS helps depression more than adding a placebo (sugar pill). TMS uses magnetic pulses to stimulate the brain, and the study will test two types. It is for adults ages 18–80 with major depressive disorder.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a diagnosis of major depressive disorder (MDD), a type of depression.
  • Speak English.
  • Be 18–80 years old.
  • Be able to swallow capsules.

Who can't join

  • Have kidney disease.
  • Have a known allergy to D-serine.
  • Take medicines known to interact with the study drug.
  • Be a child.
  • Be pregnant or breastfeeding.
  • Have metal or devices inside the body. This may rule you out after a safety review.
  • Have seizures now or in the past. This may rule you out after a safety review.
  • Currently use substances that may greatly change seizure risk. This may rule you out after a safety review.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

MA