This two-part clinical trial (n=16) investigated the safety and potential antidepressant effects of vaporized 5-MeO-DMT (GH001) in patients with treatment-resistant depression (TRD). Phase I (n=8) tested two single doses (12mg and 18mg) for safety, while Phase II (n=8) evaluated an individualized dosing regimen with up to three increasing doses (6mg, 12mg, 18mg) in a single day for efficacy. The results showed GH001 was well-tolerated and had potent and rapid antidepressant effects, with 87.5% of patients in the Phase 2 group achieving remission by day seven.
Abstract of A Phase I/II trial to assess safety & efficacy of 5-MeO-DMT (GH001) in patients with TRD
“Background: Treatment-resistant depression (TRD) is a substantial public health burden, but current treatments have limited effectiveness. The aim was to investigate the safety and potential antidepressant effects of the serotonergic psychedelic drug 5-MeO-DMT in a vaporized formulation (GH001) in adult patients with TRD.
Methods: The Phase 1 part (n = 8) of the trial investigated two single dose levels of GH001 (12 mg, 18 mg) with a primary endpoint of safety, and the Phase 2 part (n = 8) investigated an individualized dosing regimen (IDR) with up to three increasing doses of GH001 (6 mg, 12 mg, and 18 mg) within a single day, with a primary endpoint of efficacy, as assessed by the proportion of patients in remission (MADRS ≤ 10) on day 7.
Results: Administration of GH001 via inhalation was well tolerated. The proportion of patients in remission (MADRS ≤ 10) at day 7 was 2/4 (50%) and 1/4 (25%) in the 12 mg and 18 mg groups of Phase 1, respectively, and 7/8 (87.5%) in the IDR group of Phase 2, meeting its primary endpoint (p < 0.0001). All remissions were observed from day 1, with 6/10 remissions observed from 2 h. The mean MADRS change from baseline to day 7 was −21.0 (−65%) and − 12.5 (−40%) for the 12 and 18 mg groups, respectively, and − 24.4 (−76%) for the IDR.
Conclusion: Administration of GH001 to a cohort of 16 patients with TRD was well tolerated and provided potent and ultra-rapid antidepressant effects. Individualized dosing with up to three doses of GH001 on a single day was superior to single dose administration.”
Authors: Johannes T. Reckweg, Cees J. van Leeuwen, Cécile Henquet, Therese van Amelsvoort, Eef L. Theunissen, Natasha L. Mason, Riccardo Paci, Theis H. Terwey & Johannes G. Ramaekers
Summary of A Phase I/II trial to assess safety & efficacy of 5-MeO-DMT (GH001) in patients with TRD
5-MeO-DMT is a naturally-occurring serotonergic psychedelic from the tryptamine class used in naturalistic contexts to induce altered states of consciousness, including feelings of unity and connectedness with the universe. It has also been used to treat depression in people with self-reported depression.
Serotonergic psychedelics could address the unmet need for treatment-resistant depression by improving the therapeutic response to at least one pharmacotherapy, one pharmacotherapy and one psychotherapy, or two pharmacotherapies within the same depressive episode.
This study aimed to investigate the safety and efficacy of GH001, a proprietary vaporized 5-MeO-DMT formulation, in patients with TRD. The study used an individualized dosing regimen, which was designed to control the significant inter-personal dose-response variability, which has been described for 5-MeO-DMT and other serotonergic psychedelics.
Find this paper
https://doi.org/10.3389/fpsyt.2023.1133414
Open Access | Google Scholar | Backup | 🕊
Cite this paper (APA)
Reckweg, J. T., van Leeuwen, C. J., Henquet, C., Van Amelsvoort, T., Theunissen, E. L., Mason, N. L., ... & Ramaekers, J. G. (2023). A phase 1/2 trial to assess safety and efficacy of a vaporized 5-methoxy-N, N-dimethyltryptamine formulation (GH001) in patients with treatment-resistant depression. Frontiers in Psychiatry, 14, 1133414.
Study details
Compounds studied
5-MeO-DMT
Topics studied
Treatment-Resistant Depression
Depression
Study characteristics
Original
Open-Label
Participants
16
Humans
Authors
Authors associated with this publication with profiles on Blossom
Johannes RamaekersJohannes Ramaekers is a professor at Maastricht University his work focuses on behavioral toxicology of drugs and combines methods from psychopharmacology, forensic toxicology and neuroscience to determine drug-induced changes in human performance. Some of this research is done with DMT.
Institutes
Institutes associated with this publication
GH ResearchGH Research is developing several 5-MeO-DMT based therapeutic mechanisms for various mental health disorders.
Compound Details
The psychedelics given at which dose and how many times
5-MeO-DMT 6 - 18mg | 3x
Linked Research Papers
Notable research papers that build on or are influenced by this paper
A phase 1, dose-ranging study to assess safety and psychoactive effects of a vaporized 5-methoxy-N,N-dimethyltryptamine formulation (GH001) in healthy volunteersThis Phase I study assessed the safety and psychoactive effects of 5-MeO-DMT (GH001) in healthy volunteers (n=22). Single doses of 6, 12, and 18 mg of the inhaled GH001 formulation of 5-MeO-DMT were able to induce a peak experience in a minority of participants. An individualized dose escalation regimen produced a peak experience in every participant. Measures of cognition, mood, and well-being were not affected by 5-MeO-DMT. Adverse events were generally mild and resolved spontaneously.
Linked Clinical Trial
Clinical Study of GH001 in DepressionThe aim of the study is to investigate the safety of GH001 (containing 5-methoxy-dimethyltryptamine; 5-MeO-DMT), and to investigate its effects on severity of depressive symptoms, and its dose-related psychoactive effects in patients with Treatment-Resistant Depression (TRD).