Clinical TrialBipolar Disorder5-MeO-DMTTerminated

Phase 2 Clinical Trial of GH001 in Bipolar II Disorder

Open-label, single-arm Phase II multicentre study (n=6 actual) evaluating inhaled GH001 individualized dosing regimen (up to three escalating doses 6, 12, 18 mg in one day) in adults with bipolar II disorder experiencing a major depressive episode.

Target Enrollment
6 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

Multicentre, open-label, single-group Phase II trial of inhaled GH001 (5-MeO-DMT) in adults with bipolar II depression. Participants receive an individualized dosing regimen (IDR) of up to three escalating inhaled doses (6 mg, 12 mg, 18 mg) administered on a single day.

Primary purpose is treatment; dosing escalates within-session until a peak experience is achieved. Safety, tolerability and depressive symptom change are assessed per protocol across follow-up visits.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

GH001 IDR

experimental

Individualised inhaled dosing regimen (up to 3 escalating doses in a single day)

Interventions

  • 5-MeO-DMT6 - 18 mg
    via Inhalation• single day• 3 doses total

    IDR: up to three escalating doses (6, 12, 18 mg) on same day; subsequent doses only if no peak experience.

Participants

Ages
18 – 64
Sexes
Male & Female

Inclusion Criteria

  • Is male or female and in the age range between 18 and 64 years (inclusive) at screening
  • Has a body mass index (BMI) in the range of 18.5 and 35 kg/m2 (inclusive) at screening
  • Meets the trial criteria for bipolar II disorder and is experiencing a major depressive episode, as assessed by a trial psychiatrist or registered clinical psychologist

Exclusion Criteria

  • Has bipolar II disorder with rapid cycling (four or more episodes of hypomania or depressive episodes in previous 12-month period)
  • Has, based on history, psychiatric assessment, and evaluation of the MINI, a current or prior diagnosis of bipolar I disorder, a manic episode, a psychotic disorder, MDD or other mood disorder with psychotic features, obsessive compulsive disorder, PTSD, autism spectrum disorder, borderline personality disorder, schizophrenia, delusional disorder, paranoid personality disorder, schizoaffective disorder, clinically significant intellectual disability, or any other psychiatric comorbidity that renders the patient unsuitable for the trial according to the investigator's judgment
  • Has one or more first degree relatives with a current or previously diagnosed psychotic disorder, bipolar I disorder or MDD with psychotic features
  • Has taken prohibited medication or prohibited dietary supplements within the specified timeframe prior to dosing
  • Has previously experienced a significant adverse reaction to a hallucinogenic or psychedelic drug according to the investigator's judgment
  • Has a clinically significant abnormality in physical examination, vital signs, ECG, or clinical laboratory parameters which renders the patient unsuitable for the trial according to the investigator's judgment

Study Details

  • Status
    Terminated
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment6 participants
  • Timeline
    Start: 2023-04-06
    End: 2023-12-01
  • Compound
    5-MeO-DMT
  • Topic
    Bipolar Disorder

Locations

Investigational Site — Dresden, Germany
Investigational Site — Frankfurt, Germany
Investigational Site — Münster, Germany
Investigational Site — Leiden, Netherlands
Investigational Site — Maastricht, Netherlands
Investigational Site — London, United Kingdom
Investigation Site — Oxford, United Kingdom

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