Mclean Hospital
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.
Current therapeutic approaches for depression are limited in efficacy and accessibility. For many patients, Transcranial Magnetic Stimulation (TMS) has provided relief from treatment-resistant depression; however, invetigators are still far from maximizing the benefits of TMS. Here, investigators combine state-of-the-art interventions proven in depression (D-cycloserine (DCS), lurasidone (LRD), rapid intermittent Theta Burst Stimulation (iTBS)) with the aim of inducing and capitalizing on brain plasticity to support the alleviation of depressive symptoms. The rationale for pharmacologically a…
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 e…
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 is a combination capsule of fixed dose d-cycloserine (175 mg) and lurasidone (8.25 mg)
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