ArticleFrontiers in psychiatry2023
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.
Article in Frontiers in psychiatry, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04698603 (A Phase 1/2 Study of GH001 in Patients With Treatment-Resistant Depression), which is not on this map. Cited by 33 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 1/2 Study of GH001 in Patients With Treatment-Resistant Depression
Who cites it
33 citing papers in PubMed, 2 syntheses or guidelines pooled it, 79 citations in OpenAlex.
- Depressive disorders: systematic review of approved psychiatric medications (2009-April 2025) and pipeline phase 3 medications.BMC psychiatry · 2025Pooled it
- Short-term safety and tolerability profile of 5-methoxy-N,N-dimethyltryptamine in human subjects: a systematic review of clinical trials.Frontiers in psychiatry · 2024Pooled it
- GH001 vs Placebo in Patients With Treatment-Resistant Depression: A Randomized Clinical Trial.JAMA psychiatry · 2026Trial
- Dose-dependent pharmacokinetics and acute effects of intravenous bolus N,N-dimethyltryptamine: double-blind, randomized versus open-label dose-escalation administration study in healthy participants.Translational psychiatry · 2026Trial
- Mapping the phenomenology of intranasal 5-MeO-DMT in psychedelic-naïve healthy adults.Scientific reports · 2025Trial
- Safety and tolerability of multiple sublingual microdoses of 5-MeO-DMT in adults with moderate symptoms of depression and/or anxiety: a randomized, double-blind, placebo-controlled study.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2025Trial
- Rapid and sustained antidepressant effects of vaporized N,N-dimethyltryptamine: a phase 2a clinical trial in treatment-resistant depression.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2025Trial
- Phase 1, placebo-controlled, single ascending dose trial to evaluate the safety, pharmacokinetics and effect on altered states of consciousness of intranasal BPL-003 (5-methoxy-Journal of psychopharmacology (Oxford, England) · 2024Trial
- Inhalable Psychedelic 5-MeO-DMT Shows Promise in Treatment-Resistant Depression.Journal of medicinal chemistry · 2026Article
- Short- and Long-Acting Psychedelics: Structure-Activity Relationships, Pharmacology, and Implications for Neuropsychiatric Therapeutics.ACS chemical neuroscience · 2026Review
- Trials, trips, and tribulations: pathways for implementing psychedelic therapy in Ireland.The international journal of neuropsychopharmacology · 2026Review
- Landscape analysis of pre-registered clinical trials involving classical psychedelics.Journal of psychopharmacology (Oxford, England) · 2026Review
- The psychedelic phenethylamine 25C-NBF, a selective 5-HT2A agonist, shows psychoplastogenic properties and rapid antidepressant effects in male rodents.Molecular psychiatry · 2026Article
- Toward a framework for psychedelic clinical trials in adolescents.Child and adolescent psychiatry and mental health · 2026Review
- Neuropharmacology of halogenated DMT analogs: psychoplastogenic and antidepressant properties of 5-Br-DMT, a psychedelic derivative with low hallucinogenic potential.Molecular psychiatry · 2026Article
- Ayahuasca and Its Main ComponentBiomedicines · 2026Review
- Psychedelic therapeutics in psychiatric conditions.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2026Review
- Mind the gap! Addressing unresolved aspects of abuse potential evaluation and scheduling of classic and novel psychedelic drugs.Journal of psychopharmacology (Oxford, England) · 2026Review
- An exploration of the relationships between the effects of psilocybin on behavior, 5-HTJournal of psychopharmacology (Oxford, England) · 2026Article
- Flashbacks, Hallucinogen Persisting Perception Disorder (HPPD), and Reactivations Following the Use of Classic Psychedelics: Classification and Therapeutic Management.Current topics in behavioral neurosciences · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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 ( 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 ( 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.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.