depression treatment-resistant depression
Conditions
Interventions
GH001 is an inhalation formulation of synthetic
5-methoxy-N,N-dimethyltryptamine (mebufotenin, 5-MeO-DMT) for use with a
vaporizer device (the Volcano Medic 2 Vaporization System) to form an aerosol
Sponsors
GH Research Ireland Limited
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Patients are eligible for the trial if all the following criteria are met, unless they fulfil >=1 of the exclusion criteria: 1. Is informed about the trial, has given informed consent in writing, and is willing and able to comply with all requirements and rules of the trial. 2. Is in the age range between 18 and 64 years (inclusive) at the time of informed consent. 3. Meets the trial criteria for TRD as assessed by a study psychiatrist: a. Meets the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) criteria for single-episode MDD or recurrent MDD, without psychotic features confirmed by the Mini-International Neuropsychiatric Interview (MINI) 7.0.2 with current episode duration of
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria prior to the first dose of study drug are not eligible for randomization: 1. Has, based on history, psychiatric assessment, and evaluation of the MINI version 7.0.2 during the screening period, a first MDD episode after age 60, a current or prior diagnosis of a psychotic disorder, MDD, or other mood disorder with psychotic features, bipolar disorder, obsessive compulsive disorder, posttraumatic stress disorder, autism spectrum disorder, borderline personality disorder, schizophrenia, delusional disorder, paranoid personality disorder, schizoaffective disorder, clinically significant intellectual disability, antisocial personality disorder, schizotypal personality disorder, or any other psychiatric comorbidity that renders the patient unsuitable for the trial according to a study psychiatrist. 2. Has significant suicide risk as defined by (a) suicidal ideation as endorsed on items 4 or 5 on the C-SSRS within the past year, during the screening period, or at Baseline; or (b) suicidal behaviors within the past year; or (c) clinical assessment of significant suicidal risk during clinical interview; or (d) non-suicidal self-injury within the past year. 3. Has 1 or more first degree relatives with a current or prior diagnosis of bipolar disorder, psychotic disorder, or other mood disorder (including MDD) with psychotic features. 4. Undergoing systematic psychotherapy (including cognitive behavioral therapy [CBT]) that is planned to be modified or planning to initiate psychotherapy during the trial. CBT must have been ongoing for the last 3 months prior to Baseline. 5. Has any current or past clinically significant condition (e.g., severe infection, severe pulmonary disease, uncontrolled hypertension, uncontrolled diabetes, severe cardiovascular disease, valvulopathy, pulmonary hypertension, myocardial infarction, angina, or clinically significant arrythmia within the past year, severe hepatic or severe renal failure, brain disorder including seizure, stroke, dementia, aneurysm, history of intracerebral hemorrhage, degenerative neurologic diseases, meningitis, encephalitis, and head injury with loss of consciousness) that may interfere with the interpretation of the trial results, constitute a health risk for the patient, or that otherwise renders the patient unsuitable for the trial according to the investigator*s judgement. For full details please refer to the Protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Mean change in MADRS from Baseline to Day 7. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy assessments • Clinician-rated scales: o Clinical Global Impression Severity (CGI-S) o Hamilton Rating Scale for Anxiety (HAM-A) • Patient-reported outcome: o Quality of Life, Enjoyment, and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) Safety assessments • Adverse events • Clinical safety laboratory tests • Vital signs and weight • Electrocardiograms (ECGs) • Physical examinations • Spirometry • Columbia-Suicide Severity Rating Scale (C-SSRS) • Modified Observer*s Assessment of Alertness and Sedation scale (MOAA/S) • Clinician Administered Dissociative States Scale (CADSS) • Brief Psychiatric Rating Scale positive symptoms (BPRS+) • Clinical Assessment of Discharge Readiness (CADR) • Urine drug and alcohol screen Psychoactive effect assessments • Peak Experience Scale (PES) • 30-item Mystical Experience Questionnaire (MEQ30) • Challenging Experience Questionnaire (CEQ) • Psychoactive effects (PsE) duration | — |
Countries
Netherlands
Outcome results
None listed