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.
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
At a glance
Conditions
Where it's being run
3 sites across 2 statesWho to contact
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What this trial measures
- MADRS Depression6 weeks
Montgomery Asberg Depression Rating Scale Total Score
- CGI-SS Suicidality6 weeks
Clinical Global Impression Suicidality Scale