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

ConditionMajor Depression
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMclean Hospital

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • TMS

    Device

    Transcranial Magnetic Stimulation (TMS): TMS involves a procedure where a coil is placed on the scalp and magnetic energy enters the participant's brain in pulses. TMS does not alter consciousness or impose restrictions of any kind on a participant after a session. Single pulses of TMS are delivered to probe cortical excitability, as a surrogate of plasticity, before and after each treatment session. Excitability is measured with neurophysiology including electromyography (EMG). Repetitive TMS (rTMS) administered in the study is delivered in a pattern protocol called intermittent-theta burst stimulation (iTBS) which has been FDA-cleared for-and shown to be effective in-the treatment of depression. We aim to deliver up to 20 sessions per day but can adapt for patient or staff related scheduling challenges or tolerability

  • NRX-101

    Drug

    NRX-101 is a combination capsule of fixed dose d-cycloserine (175 mg) and lurasidone (8.25 mg)

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Open-label TMS + NRX-101Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in Montgomery-Åsberg Depression Rating Scale (MADRS)

Clinician-rated measure of depressive symptom severity. Higher scores indicate worse symptoms. The minimum is 0, maximum is 60.

Time frame
From day of treatment to six weeks after treatment

Secondary outcomes

1

Hamilton Depression Rating Scale (HAM-D)

Clinician-rated measure of depressive symptom severity. Higher score indicate worse symptoms. The minimum is 0, the maximum is 52.

Time frame
From day of treatment to six weeks after treatment
2

Patient Health Questionnaire 9-item (PHQ-9)

self-rated measure of depression symptom severity. Higher scores indicate worse symptoms. The minimum is 0, and the maximum is 27.

Time frame
From day of treatment to six weeks after treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mclean Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: