RightFit
Not yet recruitingEarly Phase 1

Single Day of Ultra-accelerated TMS With a Single Dose of NRX-101

SPARC-LI: Synaptic Plasticity Augmented Rapid Circuit Stimulation

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small study tests one dose of D-cycloserine and lurasidone with repeated magnetic brain stimulation (iTBS) in a single day. It is for adults with moderate to severe depression. Researchers will track changes in depression and side effects for 6 weeks.

In this pilot study, investigators aim to combine D-cycloserine, lurasidone, and single-day repeated intermittent Theta Burst Stimulation (iTBS) to preliminarily assess clinical improvement in an open-label cohort and monitor for adverse events over a 6-week follow-up period.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Adults age 18 or older, of any race or ethnic background.
  • Moderate to severe depression, with scores of at least 20 on the MADRS and at least 10 on the PHQ-9, two depression rating tools.

Who can't join

  • Past mania or hypomania (unusually high mood or energy); a lifelong history of a psychotic disorder; or current serious symptoms such as seeing things that are not there.
  • Current alcohol or drug use problems that could block treatment or cause dangerous withdrawal; or anorexia or another listed eating disorder that poses serious health risks.
  • Suicide risk that needs hospital care right away, or being hospitalized against your will.
  • A brain injury or other nerve or brain condition that raises seizure risk; past seizures; or other major seizure risk factors.
  • A diagnosed developmental disorder, such as autism or Down syndrome, or Ehlers-Danlos syndrome; delirium (sudden confusion); more than mild dementia; or thinking problems from a medical condition suggesting brain injury or intellectual impairment.
  • Pregnancy or breastfeeding. Those who could become pregnant must have a urine pregnancy test before joining, and again if pregnancy is suspected.
  • An allergy to D-cycloserine or lurasidone; or being unable to safely have magnetic brain stimulation or an fMRI brain scan because of metal in the head or neck, implanted devices, serious health problems, or other safety risks.
  • Healthy volunteers cannot join.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Male or Female adults (+18 years old) * from any ethnic or racial background * with moderate to severe depression, as indicated by scores of: ≥ 20 on the MADRS; AND ≥ 10 on PHQ-9. Exclusion Criteria: * History of manic or hypomanic symptoms; * lifetime DSM-5 psychotic spectrum disorder or current clinically significant psychotic symptoms; * active alcohol or substance use disorder that, in the opinion of a study physician/PI, is of sufficient severity to impede engagement in treatment or is associated with significant risk of medical withdrawal; * anorexia nervosa or eating disorder not otherwise specified that, in the opinion of a study physician/PI, is of sufficient severity to be associated with significant medical risks; * current suicide risk sufficient to require immediate hospitalization (C-SSRS 4 or above) * history of traumatic brain injury (TBI) that, in the opinion of a study physician/PI, would significantly increase risk of seizure; * any other significant neurological disorder likely to increase risk of seizure, in the opinion of a study physician/PI; * diagnosed neurodevelopmental disorder (e.g., autism, Down syndrome; Ehlers-Danlos Syndrome); * current diagnosis of delirium or greater than mild dementia; * cognitive disorder secondary to a general medical condition suggesting probable TBI or intellectual impairment; * Pregnant and breastfeeding women are not eligible to participate in this study excluded in line with prior work using DCS and TMS (Rossi et al., 2021). To confirm eligibility, all female participants of childbearing potential will be required to undergo a urine pregnancy test prior to enrollment. Additionally, if at any point during the study the participant or the researcher suspects that the participant may have become pregnant, a urine pregnancy test will be administered to ensure continued eligibility; * Participants with contraindications to TMS (e.g., metal in head or neck area), or at increased risk for adverse events (e.g., seizure history or markedly heightened risk factors for seizures, serious medical problems, implanted devices) will be excluded; * Participants with a known allergy to DCS or LRD will be excluded; * fMRI contraindications follow those of TMS and individuals unable to safely receive either will be excluded; * No healthy volunteers will be recruited; * No patients with involuntary hospitalization status will be recruited.

Study sites (1)

MA