Clinical TrialTreatment-Resistant Depression (TRD)5-MeO-DMT5-MeO-DMT5-MeO-DMTCompleted

Clinical Study of GH001 in Depression

The 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).

Target Enrollment
16 participants
Study Type
Phase I/II interventional
Design
Non-randomized

Detailed Description

Phase 1/2, open-label, non-randomised, sequential study in patients with treatment-resistant depression testing inhaled GH001 (5‑MeO‑DMT) in two single-dose levels (Part A) and an individualized dosing regimen (Part B).

Primary objectives: safety/tolerability of single doses (Part A) and effect of individualized dosing on depressive symptom severity (Part B). Outcomes include safety measures and depression rating scales across acute and follow-up assessments.

Study Arms & Interventions

Dose A

experimental

Phase 1 (Part A) single inhaled GH001 dose - dose level A.

Interventions

  • 5-MeO-DMT
    via Inhalation• single dose

    GH001 (5‑MeO‑DMT) administered via inhalation; Part A dose A.

Dose B

experimental

Phase 1 (Part A) single inhaled GH001 dose - dose level B.

Interventions

  • 5-MeO-DMT
    via Inhalation• single dose

    GH001 (5‑MeO‑DMT) administered via inhalation; Part A dose B.

Individualised

experimental

Phase 2 (Part B) individualized inhaled GH001 dosing regimen.

Interventions

  • 5-MeO-DMT
    via Inhalation• individualised regimen

    GH001 (5‑MeO‑DMT) individualized inhalation dosing; Part B.

Participants

Ages
18 – 64
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Has a body mass index (BMI) in the range of 18.5 and 35.0 kg/m2 (inclusive);
  • Meets the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria for single-episode major depressive disorder (MDD) or recurrent MDD, without psychotic features confirmed by the Mini-International Neuropsychiatric Interview (MINI);
  • Treatment-Resistant Depression as evaluated by the Antidepressant Treatment History Form - Short Form (ATHF-SF);
  • Has outpatient status at screening and enrolment visits;

Exclusion Criteria

  • Exclusion Criteria:
  • Has a current or prior diagnosis of a psychiatric comorbidity that renders the patient unsuitable for the study according to a study psychiatrist or registered psychologist;
  • Has received any investigational medication within the last 1 month;
  • Has a current medically significant condition (e.g., severe infection) or has a history of a medically significant condition (e.g., medical history of seizure, uncontrolled hypertension, uncontrolled diabetes, severe cardiovascular disease, hepatic or renal failure, etc.) that renders the patient unsuitable for the study according to the medical supervisor's judgment;
  • Takes any medication or other substance that renders the patient unsuitable for the study according to the medical supervisor's judgment;
  • Has a clinically significant abnormality in physical examination, vital signs, ECG, or clinical laboratory parameters, which renders the patient unsuitable for the study according to the medical supervisor's judgment;

Study Details

Locations

Clinical Trial Site — Maastricht, Netherlands

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