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Ultra-accelerated TMS + NRX-101 for Depression

(SPARC-LI Trial)

PG
DW
Overseen ByDennis W Guevara
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Mclean Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

KR

Kerry Ressler, MD, PhD

Principal Investigator

Mclean Hospital

Are You a Good Fit for This Trial?

Inclusion Criteria

From any ethnic or racial background
Moderate to severe depression indicated by scores of ≥ 20 on the MADRS and ≥ 10 on PHQ-9
I am 18 years old or older.

Exclusion Criteria

Contraindications to TMS including metal in head or neck, seizure history or high seizure risk, serious medical problems, or implanted devices
I have a diagnosed neurodevelopmental disorder like autism or Down syndrome.
fMRI contraindications consistent with TMS contraindications
See 13 more

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Open-label TMS + NRX-101Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mclean Hospital

Lead Sponsor

Trials
221
Recruited
22,500+

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