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.
Non-childbearing potential: physiologically incapable of becoming pregnant (i.e., permanently sterilized [status posthysterectomy, bilateral tubal ligation], or post-menopausal with last menses at least one year prior to Screening); or
Myocardial infarction within 1 year of Screening.
Diagnosis of angina pectoris.
Prolonged QTc interval, as measured by Fridericia's correction formula (QTcF) ≥450 msec at Screening for males or ≥ 470 msec for females on 2 of 3 measurements at least 15 minutes apart prior to randomization on Day 1. 16. Diagnosis of chronic lung disease, excluding asthma. 17. Lifetime history of any of the following: neurologic conditions with structural cerebral damage, traumatic brain injury, multiple sclerosis, surgical procedures involving the brain or meninges, meningoencephalitis, degenerative central nervous system (CNS) disorder (e.g., Alzheimer's Disease, Parkinson's Disease), mental retardation, stroke (ischemic or hemorrhagic), intracranial abscess, or any other disease/procedure/accident/intervention that, according to the clinician, is deemed associated with significant injury to, or malfunction of, the CNS. 18. History of epilepsy, personal history of seizure, family history of epilepsy or seizure in a first degree relative. 19. Diagnosis of parenchymal or leptomeningeal cancer.
Unstable diabetes mellitus defined as glycosylated hemoglobin (HbA1c) >8.0 percent at Screening.
Parallel
Neuronavigated robotic-enabled TMS
DeviceOne 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
DrugD-cycloserine 175mg + Lurasidone 8.5mg
Sham TMS
DeviceAn Apollo TMS device configured not to deliver effective energy to the brain
Oral Placebo
DrugAn oral placebo capsule visually identical to NRX-101
MADRS Depression
Montgomery Asberg Depression Rating Scale Total Score
CGI-SS Suicidality
Clinical Global Impression Suicidality Scale
EMOCARE Depression Thermometer
EMOCARE Smartphone application that measures depression with 0.89 correlation to the MADRS using voice prosity, facial recognition, activity, and screen behavior
Percent Response on MADRS
Percent Response from Depression
Percent Remission from Depression on MADRS
Percent Remission from Depression
Percent Remission from Suicidality on CGI-SS
Percent Remission from Suicidality
Click on the lead sponsor to view all of their trials.
NeuroRx, Inc.
Lead sponsor
Zeta Surgical, Inc.
Collaborator
neurocare group AG
Collaborator
HOPE Therapeutics, Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
