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Bipolar Depression clinical trials

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NCT ID: NCT05779267 Available - Bipolar Depression Clinical Trials

NRX-101 Expanded Access

NRX-101EAP
Start date: n/a
Phase:
Study type: Expanded Access

There is no currently-approved pharmacotherapy for patients with Treatment-Resistant Bipolar Depression and Suicidal Ideation or behavior. The purpose of this Expanded Access Treatment Protocol is to make NRX-101 available to patients who have depression and suicidal ideation despite treatment with currently approved medication and to gather information on safety and efficacy in a real-world data environment. Participants will be treated by their own practicing psychiatrist and will agree to periodic psychometric evaluations to assess depression, suicidal ideation, and side effects.