SPARC-TMS Trial for Treatment-Resistant Depression

This study is for adults with treatment-resistant depression (TRD), meaning depression that hasn't improved with standard treatments. We are testing if a combination of medications, NRX-101 (D-cycloserine and Lurasidone), can improve the effectiveness of a special type of brain stimulation called robotic transcranial magnetic stimulation (TMS). TMS uses magnetic pulses to stimulate specific areas of the brain. You would receive either the active NRX-101 medication or a placebo (an inactive pill), along with either active TMS or a sham (inactive) TMS. We will measure how well the treatment works by looking at changes in your depression symptoms and suicidality after 6 weeks. This study aims to enroll 400 participants.

Study design
This is a randomized, double-blind controlled study, meaning participants are randomly assigned to a treatment group and neither you nor the study staff will know which treatment you are receiving. It plans to enroll 400 participants.
What's involved
You would be initiating a new course of TMS treatment and must not have received TMS before. You would need to understand and sign an informed consent form and be able to follow the study protocol, including reporting any side effects.
Compensation
Not stated in the trial record.
Follow-up
Your depression and suicidality will be measured at 6 weeks after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07227103

A Randomized, Double-Blind Controlled Comparison of NRX-101 vs. Placebo for Adults Being Treated With Robotic Transcranial Magnetic Stimulation for Treatment Resistant Depression: The SPARC-TMS Trial

Not Yet Recruiting
PHASE2Ages 18–80InterventionalTreatment
NeuroRx, Inc.
~400 participants
Updated 2026-06-24 on ClinicalTrials.gov
What's tested:Neuronavigated robotic-enabled TMSNRX-101Sham TMSOral Placebo

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
MADRS Depression
Measured over 6 weeks
+1 more outcome measured
Treatment Resistant Depression
Treatment Resistant Depression (TRD)
3 sites across 2 states
Florida2
Massachusetts1

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  • MADRS Depression6 weeks

    Montgomery Asberg Depression Rating Scale Total Score

  • CGI-SS Suicidality6 weeks

    Clinical Global Impression Suicidality Scale