NMDA Receptor Modulation for Hyperarousal in PTSD

Summary

This Phase 1b study examines the safety and efficacy of parenterally-administered lanicemine in a parallel-arm, randomized, double-blind, placebo-controlled trial in adult patients (N=24) with significant PTSD symptoms and elevated anxiety potentiated startle (APS). Investigator hypothesize that lanicemine (100 mg) displays a normalization of APS following three infusions over 5 non-consecutive days. If target engagement is demonstrated and the drug is safe and tolerable in this patient population, investigator will proceed to a larger POC study.

Timeline

Start

2018-09-01

Primary completion

2019-11-12

Completion

2019-11-14

Publications

• Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for prevention of post-traumatic stress disorder (PTSD) in individuals experiencing acute traumatic stress symptoms. Cochrane Database Syst Rev. 2024 May 20;5(5):CD013613. doi: 10.1002/14651858.CD013613.pub2.
• Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for universal prevention of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2022 Feb 10;2(2):CD013443. doi: 10.1002/14651858.CD013443.pub2.
• Ramakrishnan N, Lijffijt M, Green CE, Balderston NL, Murphy N, Grillon C, Iqbal T, Vo-Le B, O'Brien B, Murrough JW, Swann AC, Mathew SJ. Neurophysiological and clinical effects of the NMDA receptor antagonist lanicemine (BHV-5500) in PTSD: A randomized, double-blind, placebo-controlled trial. Depress Anxiety. 2021 Nov;38(11):1108-1119. doi: 10.1002/da.23194. Epub 2021 Jul 12.
• Murphy N, Lijffijt M, Ramakrishnan N, Vo-Le B, Vo-Le B, Iqbal S, Iqbal T, O'Brien B, Smith MA, Swann AC, Mathew SJ. Does mismatch negativity have utility for NMDA receptor drug development in depression? Braz J Psychiatry. 2022 Jan-Feb;44(1):61-73. doi: 10.1590/1516-4446-2020-1685.
• Lijffijt M, Green CE, Balderston N, Iqbal T, Atkinson M, Vo-Le B, Vo-Le B, O'Brien B, Grillon C, Swann AC, Mathew SJ. A Proof-of-Mechanism Study to Test Effects of the NMDA Receptor Antagonist Lanicemine on Behavioral Sensitization in Individuals With Symptoms of PTSD. Front Psychiatry. 2019 Dec 13;10:846. doi: 10.3389/fpsyt.2019.00846. eCollection 2019.

Drugs

Indications