Phase 1/2 study of GH001 in depressio

Phase 1

• Conditions: Treatment-resistant depression; MedDRA version: 20.0Level: PTClassification code 10012378Term: DepressionSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 21.1Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 21.1Level: LLTClassification code 10025453Term: Major depressive disorder NOSSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2018-004208-20-NL
• Lead Sponsor: Gh Research Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-01
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 16

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 <1%) medically accepted contraceptive method during the investigational period;
6.Has outpatient status at screening and enrolment visits
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified