Treatment-resistant depression MedDRA version: 20.0 Level: PT Classification code 10012378 Term: Depression System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 21.1 Level: PT Classification code 10057840 Term: Major depression System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 21.1 Level: LLT Classification code 10025453 Term: Major depressive disorder NOS System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Code: GH001
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: 5-methoxy-N,N-dimethyltryptamine
CAS Number: 1019-45-0
Current Sponsor code: GH001
Concentration unit: mg milligram(s
Sponsors
Gh Research Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients meeting the following criteria will be included into the administration phase, unless they fulfil one or more of the exclusion criteria: 1. Is male or female and in the age range between 18 and 64 years (inclusive); 2. Has a body mass index (BMI) in the range of 18.5 and 35.0 kg/m2 (inclusive); 3. 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); 4. Has treatment-resistant depression as assessed using the Antidepressant Treatment History Form – Short Form (ATHF-SF) 5. Female patients of childbearing potential must be either surgically sterile (hysterectomy, tubal ligation, or bilateral oophorectomy) or postmenopausal with amenorrhea for the last 2 years or use a highly effective (failure rate =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Has received any investigational medication within the last 1 month; 2. Has known allergies or hypersensitivity or any other contraindication to 5-MeO-DMT; 3. 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; 4. Takes any medication or other substance that renders the patient unsuitable for the study according to the medical supervisor’s judgment; 5. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase 1 (Part A): Primary objective: The primary objective of this study is to assess the safety and tolerability of single-day dosing of GH001 in patients with TRD. Phase 2 (Part B): Primary objective: The primary objective of this study is to assess the effects of single-day dosing of GH001 on the severity of depression. ;Secondary Objective: Phase 1 (Part A): Secondary Objective(s): The secondary objectives of the study are to assess the effects of single-day dosing of GH001 on various measures of depression, and on dose-related psychoactive effects. Phase 2 (Part B): Primary objective: The primary objective of this study is to assess the effects of single-day dosing of GH001 on the severity of depression. Secondary Objective(s): The secondary objectives of the study are to assess the safety and tolerability of single-day dosing of GH001 in patients with TRD and its effects on the severity of depression, other measures of depression, and on dose-related psychoactive effects. ;Primary end point(s): Phase 1 (Part A): - The safety and tolerability of GH001 administered via inhalation as evaluated by a panel of measures Phase 2 (Part B): - The effect of GH001 on the severity of depression, as evaluated by mean change in MADRS total score ;Timepoint(s) of evaluation of this end point: up to 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Phase 1 (Part A): - The effect of GH001 on the severity of depression, as evaluated by mean change in MADRS total score Phase 2 (Part B): - The safety and tolerability of GH001 administered via inhalation as evaluated by a panel of measures;Timepoint(s) of evaluation of this end point: up to 7 days | — |
Countries
Netherlands
Contacts
Public ContactGH Research Clinical Team
GH Research Limited
Outcome results
None listed