CLINICAL TRIALS PROFILE FOR BUFOTENIN
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Clinical Trials for Bufotenin
Trial ID | Title | Status | Sponsor | Phase | Summary |
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NCT05163691 ↗ | Pharmacokinetics of GH001 in Healthy Volunteers | Completed | GH Research Ireland Limited | Phase 1 | The primary objective of this study is to investigate the serum pharmacokinetics of 5-MeO-DMT and its metabolite, bufotenine in healthy volunteers in a double-blind, placebo-controlled, randomized study design with single, inhaled doses of GH001 and in an open-label, non-randomized study design with intra-subject dose-escalation of GH001. As a secondary objective, the safety and tolerability of GH001, the mental health and well-being of the subjects after GH001 dosing(s), the pharmacodynamic profile of GH001 as evaluated by its psychoactive effects, and cognitive measures are also assessed. |
NCT05753956 ↗ | Safety and Pharmacokinetics of GH002 in Healthy Volunteers | Recruiting | GH Research Ireland Limited | Phase 1 | The primary objectives of this study are to investigate the safety and serum pharmacokinetics of 5-MeO-DMT in healthy volunteers in a double-blind, placebo-controlled, randomized study design with single, injected doses of GH002 and in an open-label, non-randomized study design with intra-subject dose-escalation of GH002. As secondary objectives, the PK/ pharmacodynamic relationship, PD profile of GH002 as evaluated by its psychoactive effects and impact on cognitive performance, and the serum PK of the metabolite bufotenine are also assessed. |
NCT05800860 ↗ | A Trial of GH001 in Patients With Treatment-resistant Depression | Recruiting | GH Research Ireland Limited | Phase 2 | The aim of this randomized, double-blind, placebo-controlled, phase 2b clinical trial is to investigate the safety and efficacy of GH001 (containing mebufotenin [5-methoxy-N,N-dimethyltryptamine; 5-MeO-DMT]) in patients with treatment-resistant depression (TRD). The study is comprised of a 7-day double-blind (DB) part (Part 1) and a 6-month open-label extension (OLE) part (Part 2). Patients will be randomized to receive GH001 or placebo in a 1:1 ratio. The primary endpoint is the mean change in the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to Day 7. |
NCT05804708 ↗ | Phase 2 Clinical Trial of GH001 in Postpartum Depression | Recruiting | GH Research Ireland Limited | Phase 2 | This study is a multicenter, open-label, single-arm Phase 2 clinical trial. Approximately 15 female participants with clinically diagnosed postpartum depression (PPD) will be included in this study. The participants will receive an individualized dosing regimen (IDR) with at least one and up to three doses of GH001 administered within a single day. |
NCT05839509 ↗ | Phase 2 Clinical Trial of GH001 in Bipolar II Disorder | Recruiting | GH Research Ireland Limited | Phase 2 | This study is a multicenter, open-label, single-arm Phase 2 clinical trial. Approximately 15 participants with clinically diagnosed bipolar disorder (BD) type II and experiencing a current episode of depression will be included in this study. The participants will receive an individualized dosing regimen (IDR) with at least one and up to three doses of GH001 administered within a single day. |
>Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
Clinical Trial Conditions for Bufotenin
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Clinical Trial Locations for Bufotenin
Clinical Trial Progress for Bufotenin
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Clinical Trial Sponsors for Bufotenin
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