Northcote

Researchers are evaluating the efficacy, safety, and tolerability of VLS-01 buccal film VLS-01-BU in adults with treatment resistant Major Depressive Disorder TRD. This Phase 2, multicenter, randomized, placebo-controlled trial aims to understand the onset and duration of antidepressant effects of VLS-01-BU compared to placebo in patients who have not responded to previous treatments. Participants will be randomly assigned to receive two doses of either VLS-01-BU or placebo administered via a buccal transmucosal film, with two weeks between doses. After a 12-week follow-up monitoring period, all participants will be re-randomized to receive one additional dose of VLS-01-BU at one of two dose strengths. Safety and efficacy will be assessed two weeks after this third dose during a non-placebo-controlled treatment phase. Throughout the study, participants depressive symptoms will be regularly monitored using the Montgomery-sberg Depression Rating Scale MADRS from baseline to Day 29 and through Day 43. The study includes multiple assessments to measure the antidepressant effects and safety of the treatment. The total duration of participant involvement covers the initial dosing, follow-up, re-randomization, and final evaluation, ensuring thorough observation of treatment impact and tolerability.

Researchers are evaluating the safety and effectiveness of NPX-5 in psilocybin-assisted psychotherapy PAP for treating adjustment disorder symptoms caused by the stress of a cancer diagnosis. This Phase IIb randomized, double-blind study involves adults aged 18 to 80 who experience anxiety after adjusting to their cancer diagnosis. The goal is to develop scientific knowledge that may lead to new treatments for anxiety and depression following such stressful events. Participants are randomly assigned to receive one of three doses of NPX-525 mg, 10 mg, or 1 mgduring an approximately 8-hour PAP dosing session on Day 14. Those who do not respond by Week 10 and still meet eligibility criteria may receive a second PAP cycle at the 25 mg dose. A maximum of two PAP cycles can be given. The study includes preparation sessions before dosing and follow-up visits after treatment, combining in-person clinic visits and telehealth appointments. Participants will attend screening visits, preparation sessions, dosing and integration sessions, and several follow-up visits up to three months after their final PAP cycle. Assessments include anxiety severity using the Hamilton Anxiety Rating Scale, suicidality monitoring, vital sign checks, and safety evaluations. The study monitors treatment-related adverse events and long-term safety and tolerability of NPX-5, with the final safety follow-up occurring three months after the last treatment cycle.

Researchers are studying the safety and effectiveness of HB-1 compared to a placebo in adults aged 18 to 65 years who have Post-Traumatic Stress Disorder PTSD. This is a phase 2, multi-center, double-blind, placebo-controlled trial involving approximately 200 to 500 adults diagnosed with PTSD who do not have severe neuropsychiatric or medical conditions. The study takes place at multiple sites in Australia and the United States. Participants will receive either HB-1 or a placebo tablet once daily for 12 weeks. HB-1 doses start at 64192 mg of telmisartanverapamil extended release and may be increased to 86258 mg based on treatment response and tolerance assessed at weeks 4 and 8. Those showing a 50% or greater reduction in PTSD symptoms remain on the same dose, while others without severe side effects may have their dose increased. A safety follow-up visit occurs one week after the last dose to monitor any adverse effects. During the study, participants will undergo assessments at baseline, week 4, week 8, and week 12, including symptom rating scales such as CAPS-5 and other PTSD-related questionnaires. Safety evaluations include monitoring for adverse events, vital signs, ECGs, and laboratory tests. The studys main goal is to measure changes in clinician-rated PTSD symptoms, along with secondary measures of stress, symptoms, and disability. Participation lasts for approximately 13 weeks including treatment and safety follow-up.