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 MIND1 Trial

Part of paid clinical trials in Sarasota, Florida.

Sponsor
NeuroRx, Inc.
Study ID
NCT07227103
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Treatment Resistant Depression
  • Treatment Resistant Depression (TRD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Neuronavigated robotic-enabled TMS — DEVICE
    One Day TMS Protocol performed with the Zeta Surgical neuronavigated robotic-enabled system and the neurocare Apollo TMS Device 30 Theta burst pulses delivered as per protocol
  • NRX-101 — DRUG
    D-cycloserine 175mg + Lurasidone 8.5mg
  • Sham TMS — DEVICE
    An Apollo TMS device configured not to deliver effective energy to the brain
  • Oral Placebo — DRUG
    An oral placebo capsule visually identical to NRX-101

Study Details

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 the AMPA 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 + D-cycloserine vs. TMS+placebo.

Key Dates

Start date
Sep 1, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Transcranial Magnetic Stimulation plus NRX-101
    Participants are treated with ONE-D TMS plus NRX-101 175mg DCS/8.5mg Lurasidone once daily for five days
  • Placebo Comparator: Transcranial Magnetic Stimualtion
    Participants are treated with ONE-D TMS plus placebo once daily for five days
  • Experimental: Sham TMS + NRX-101
    Participants will be treated with Sham TMS (i.e. a TMS coil that does not deliver effective energy to the brain) + NRX-101

Primary Outcome Measure

MADRS Depression [ Time Frame: 6 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Cohen and AssociatesSarasotaFlorida34239
Kimberly H Joffee, APRN, PMHNP
[email protected]
(561) 277-3088
Rebecca Cohen, MD
[email protected]
(941) 559-8500
HOPE Accelerated CareWest Palm BeachFlorida33417
Kimberly H Joffee, APRN, PMHNP
[email protected]
(561) 277-3088
Rebecca Cohen, MD
[email protected]
(941) 559-8500
Harvard Mclean HospitalBelmontMassachusetts02478
Kerry Ressler, MD
[email protected]
617.855.4210

Find similar trials in Sarasota, FL

By research site
Cohen and Associates· Sarasota, FLHOPE Accelerated Care· West Palm Beach, FLHarvard Mclean Hospital· Belmont, MA

Related Studies