Northcote

Researchers are evaluating the safety, tolerability, and effectiveness of VLS-01 buccal film (VLS-01-BU) as a short-term treatment for adults with treatment resistant Major Depressive Disorder (TRD). This Phase 2, multicenter, double-blind, randomized, placebo-controlled trial aims to compare antidepressant effects of VLS-01-BU against placebo, focusing on the onset and durability of these effects. About 142 participants with TRD will be randomly assigned in equal groups to receive two doses of either VLS-01-BU or placebo via buccal transmucosal administration, spaced two weeks apart. Following this placebo-controlled period, symptoms will be monitored for 12 weeks. Then, all participants will be re-randomized to receive a single additional double-blind dose of VLS-01-BU at one of two dose strengths during a non-placebo-controlled treatment phase. Safety and efficacy will be assessed two weeks after the third dose. Participants will be closely monitored throughout the study, including during the 12-week follow-up after the second dose and after the final treatment. Researchers will measure changes in depression severity using the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to Day 29. Safety evaluations and tolerability assessments will also be conducted to understand the effects and duration of VLS-01-BU treatment.

Researchers are evaluating the safety and effectiveness of a drug called HB-1 compared to placebo and two other medications in adults aged 18 to 65 years diagnosed with Panic Disorder. This phase 2, multicenter, randomized, double-blind, placebo-controlled trial aims to include approximately 240 to 600 participants, including those with or without certain co-existing conditions, to better understand treatment options for Panic Disorder. Participants will be randomly assigned to receive HB-1, telmisartan, verapamil, or a matched placebo, all provided as tablets. The treatment period lasts 12 weeks, after which a safety follow-up visit will occur one week after the last dose. Throughout the study, patients and researchers will not know which treatment the participants receive to ensure unbiased results. During the trial, participants will be monitored regularly for the number of unexpected panic attacks and any side effects that may arise, with assessments occurring weekly during treatment and at follow-up. Safety evaluations, including laboratory tests and questionnaires, will be conducted at specific intervals to track participants' health and treatment effects throughout the study duration.

Researchers are investigating the safety and effectiveness of NPX-5 in psilocybin-assisted psychotherapy (PAP) for treating adjustment disorder caused by the stress of a cancer diagnosis. This Phase IIb study involves adults aged 18 to 80 years who experience anxiety related to adjusting to their cancer diagnosis. The study aims to develop scientific knowledge that could support new treatments for anxiety and depression following acute stressful events like cancer diagnosis. Participants are randomly assigned to receive one of three doses of NPX-5 (25 mg, 10 mg, or 1 mg) during an approximately 8-hour PAP dosing session on Day 14. Before dosing, participants complete three preparation therapy sessions, some via telehealth and one in person. The study includes clinic visits on Day 1, Day 13, Day 14 (dosing), Day 15 (integration), and Week 10 (Day 70) post-randomization, with telehealth sessions for preparation, integration, and follow-up. Non-responders at Week 10 who still meet eligibility criteria may receive a second PAP cycle at 25 mg NPX-5. A maximum of two PAP cycles can be administered. During the study, participants undergo screening and baseline assessments, including psychiatric and medical evaluations. Researchers monitor anxiety severity using the Hamilton Anxiety Rating Scale and assess safety through vital signs and suicide risk with the Sheehan Suicide Tracking Scale at various time points up to three months after the final PAP cycle. The study uses clinic visits and telehealth calls to support participants, tracking treatment effects, safety, and tolerability throughout the study period.