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

Major depressive disorder (MDD) is a significant public health problem and leading cause of worldwide disability. Treatment resistance is common in MDD, however, for these individuals, targeted noninvasive brain stimulation is an alternative. Repetitive transcranial magnetic stimulation (rTMS) and more recently, theta-burst stimulation (TBS), are the noninvasive brain stimulation modalities with the largest evidence base in MDD. Although efficacious, an unacceptable proportion of patients do not significantly improve, and several aspects of the TMS parameter space are under investigation to enhance clinical outcomes. DCS has been shown in a randomized trial of more than double the percent response and remission from traditional TMS. When a one day (ONE-D) TMS protocol was combined with DCS, the measured response rate was 87% at one week. This trial will compare response and remission at six weeks following neuronavigated robotic-enabled Transcranial Magnetic Stimulation + NRX-101 (D-cycloserine/lurasidone) vs. TMS+placebo.

NCT Number	NCT07227103
Lead Sponsor	NeuroRx, Inc. Collaborators: Zeta Surgical, Inc., neurocare group AG, HOPE Therapeutics, Inc.
Conditions	Treatment Resistant Depression, Treatment Resistant Depression (TRD)
Enrollment	400 participants
Start Date	2026-09-01
Primary Completion	2027-12-31 (estimated)
Study Completion	2028-03-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-24