Clinical Study of GH001 in Depression

A Phase 1/2 Study of GH001 in Patients With Treatment-Resistant Depression

Sponsors

Lead Sponsor: GH Research Limited

Source GH Research Limited
Brief Summary

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). The study is comprised of two open-label, single-arm study parts where Part A evaluates single doses of GH001 at two dose levels and Part B evaluates a specific individualized dosing regimen of GH001.

Detailed Description

Phase 1 (Part A): The primary objective of this study is to assess the safety and tolerability of single doses of GH001 (containing 5-methoxy-dimethyltryptamine; 5-MeO-DMT) in patients with TRD. The secondary objectives of the study are to assess the effects of single doses of GH001 on various measures of depression, and on dose-related psychoactive effects. Phase 2 (Part B): The primary objective of this study is to assess the effects of an individualized dosing regimen of GH001 on the severity of depression. The secondary objectives of the study are to assess the safety and tolerability of an individualized dosing regimen of GH001 in patients with TRD and its effects on the severity of depression, other measures of depression, and on dose-related psychoactive effects. Study design: Phase 1/2 study in two parts. Intervention: In the Phase 1 (Part A), a single dose of GH001 will be administered per patient. Two different dose levels will be investigated with four patients at each dose level. In the Phase 2 (Part B), an individualized dosing regimen will be administered. In both parts, GH001 will be administered via inhalation.

Overall Status Recruiting
Start Date November 12, 2019
Completion Date September 2021
Primary Completion Date September 2021
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Phase 1: The safety and tolerability of GH001 as a combined measure of outcomes 5 to 13. up to 7 days
Phase 2: The effects of GH001 on the severity of depression evaluated by the Montgomery-Asberg Depression Rating Scale (MADRS) up to 7 days
Secondary Outcome
Measure Time Frame
Phase 1: The effects of GH001 on the severity of depression evaluated by the Montgomery-Asberg Depression Rating Scale (MADRS) up to 7 days
Phase 2: The safety and tolerability of GH001 as a combined measure of outcomes 5 to 13 up to 7 days
Enrollment 16
Condition
Intervention

Intervention Type: Drug

Intervention Name: 5 Methoxy N,N Dimethyltryptamine

Description: GH001 administered via inhalation

Eligibility

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: - 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;

Gender: All

Minimum Age: 18 Years

Maximum Age: 64 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
GH Research Clinical Team Study Director GH Research Limited
Overall Contact

Last Name: GH Research Clinical Team

Phone: No study phone

Email: [email protected]

Location
Facility: Status: Contact: Clinical Trial Site Study Project Manager [email protected]
Location Countries

Netherlands

Verification Date

January 2021

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Phase 1 (Part A): GH001 dose A

Type: Experimental

Label: Phase 1 (Part A): GH001 dose B

Type: Experimental

Label: Phase 2 (Part B): GH001 Individualized Dosing Regimen

Type: Experimental

Patient Data No
Study Design Info

Allocation: Non-Randomized

Intervention Model: Sequential Assignment

Intervention Model Description: Phase 1 (Part A): Two dose levels of GH001 investigated in single doses. Phase 2 (Part B): GH001 investigated in an individualized dosing regimen.

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov