A Trial of GH001 in Patients with Treatment-resistant Depression

Main Inclusion Criteria:

1. Is in the age range between 18 and 64 years (inclusive) at the time of informedconsent;

2. Meets the trial criteria for TRD as assessed by a study psychiatrist:

3. Meets the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5)criteria for single-episode major depressive disorder (MDD) or recurrent MDD,without psychotic features confirmed by the Mini-International NeuropsychiatricInterview (MINI) with current episode duration of ≤2 years;

4. The current major depressive episode must be deemed "valid" based upon theMassachusetts General Hospital State versus trait Assessability Face andEcological validity Rule of 3Ps (MGH SAFER) criteria interview;

5. Had nonresponse (≤25% improvement) to ≥2 and ≤5 oral antidepressant treatmentsadministered during the current episode of depression.

Main Exclusion Criteria:

1. Has, based on history, psychiatric assessment, and evaluation of the MINI during thescreening period, a first MDD episode after age 60, a current or prior diagnosis ofa psychotic disorder, MDD, or other mood disorder with psychotic features, bipolardisorder, obsessive compulsive disorder, posttraumatic stress disorder, autismspectrum disorder, borderline personality disorder, schizophrenia, delusionaldisorder, paranoid personality disorder, schizoaffective disorder, clinicallysignificant intellectual disability, antisocial personality disorder, schizotypalpersonality disorder, or any other psychiatric comorbidity that renders the patientunsuitable for the trial according to a study psychiatrist;

2. Has significant suicide risk;

3. Has 1 or more first degree relatives with a current or prior diagnosis of bipolardisorder, psychotic disorder, or other mood disorder (including MDD) with psychoticfeatures;

4. Undergoing systematic psychotherapy that is planned to be modified or planning toinitiate psychotherapy during the trial;

5. Has any current or past clinically significant condition that may interfere with theinterpretation of the trial results, constitute a health risk for the patient, orthat otherwise renders the patient unsuitable for the trial according to theinvestigator's judgement;

6. Fulfils criteria for DSM-5 alcohol or substance use disorder (excluding tobacco andcaffeine use disorders) within the preceding 1 year, as assessed via the MINI;

7. Is taking antidepressants, antipsychotics, or any medication with monoamine oxidaseinhibitors activity or takes or has taken other disallowed recent or concomitanttreatments or it is anticipated that the patient will require treatment with atleast 1 of the disallowed concomitant treatments during the trial;

8. Has previously experienced a significant adverse reaction to a hallucinogenic orpsychedelic drug (e.g., psilocybin, Psilocybe spp. mushrooms, 5-MeO-DMT, DMT,ayahuasca, lysergic acid diethylamide, mescaline) according to the investigator'sjudgement.