NRX101 for Bipolar Depression (MBD Trial)

"Currently, 5 trials for NRX-101 are in progress with 2 of them at Phase 3. Dallas, Texas remains the primary hub for this medication's clinical trials; however 28 other sites have also been identified as operating studies related to NRX-101."

"For the duration of this six-week clinical trial, investigators will measure changes in MADRS scores at the 42nd day and monitor secondary outcomes such as modifications to C-SSRS ratings - with lower values indicating a more favourable outcome -, time to relapse defined by returns of suicidal ideation on C-SSRS or depression recurrence following an improvement of 25% on MADRS scores, and remission percentages at Day 42/exit."

"Research into NRX-101 has been ongoing since 2014, beginning with an Otsuka America Pharmaceutical sponsored study of 200 participants. Subsequently, the drug was approved for Phase 4 use and 5 active trials have emerged in 25 cities across four nations."

"Science 37 in Culver City, California, San Marcus Research Clinic, Inc. in Miami Lakes, Florida and University of Texas Health Austin in Austin, Texas are three out of fifteen clinical trial sites hosting this experiment."

"This clinical trial is recruiting 70 eligible adults (ages 18-65) with bipolar disorder and suicidal ideation. Criteria for participants include: a DSM-5 diagnosis, confirmed active suicidal thoughts without intention to act, score of 30 or higher on the MADRS scale, no co-morbidities as measured by medical history, physical exam, lab tests and ECG."

"To complete this study, 70 patients with the pre-defined eligibility requirements need to be recruited. Patients can register for this trial at Science 37 in Culver City, California and San Marcus Research Clinic Inc., located in Miami Lakes, Florida."

"According to the records stored on clinicaltrials.gov, this medical study is still recruiting participants. This trial was originally shared on May 12th 2022 and its most recent update occurred on November 25th 2022."

"This clinical trial only considers those aged 18 to 65, with 223 studies for minors and 1065 trials for individuals above the seniority threshold."

"Due to the lack of clinical evidence in support of efficacy, NRX-101 was given a safety rating of 2 on our 1 - 3 scale. This is indicative of the fact that this trial is categorized as Phase 2."