Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Mclean Hospital · Other
Who this trial is looking for
This trial is looking for adults with depression who can take capsules. Participants will receive a specific type of brain treatment along with D-serine to see if it helps their condition more than the treatment alone.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with major depressive disorder.
I am between 18 and 80 years old.
I can speak English.
I can swallow capsules.
You may not be able to join if
I have a history of seizures.
I currently use substances that may affect seizures.
I have pre-existing kidney disease.
I am allergic to D-serine.
I take medications that interact with other drugs.
I am a child.
I am pregnant or breast-feeding.
I have any implanted metal or devices.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Status
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 signi…
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.
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