New drug combo aims to tackle bipolar depression and suicidal thoughts

NCT ID NCT05779267

AVAILABLE Disease control Sponsor: NeuroRx, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 30, 2026 · Last updated Jul 21, 2026 · Updated 3 times

Summary

This study offers NRX-101, a combination of two drugs, to adults aged 18-65 with treatment-resistant bipolar depression and suicidal thoughts. Participants receive the medication from their own psychiatrist and undergo regular check-ins on mood, suicidal ideation, and side effects. The goal is to see if NRX-101 can help when standard treatments have failed.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: NRX-101 (D-cycloserine/lurasidone fixed dose combination)
What this could lead to: If successful, this could provide a new treatment option for people with bipolar depression who have not responded to other medications and are at risk of self-harm.
What could go wrong: This is an expanded access study, not a controlled trial, so results may be less reliable. The drug may cause side effects or not work for everyone.

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Conditions

The condition(s) this trial relates to.

bipolar depression bipolar disorder Depressive Disorder, Treatment-Resistant major affective disorder 6

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BIPOLAR AFFECTIVE DISORDER BIPOLAR DEPRESSION TREATMENT RESISTANT DEPRESSION

Contacts and locations

Locations

Harvard Mclean Hospital
AVAILABLE

Belmont, Massachusetts, 02478, United States

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