GH001-TRD-201
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled, Phase 2b trial with an open-label extension to determine the safety and efficacy of GH001 in patients with treatment-resistant depression
IRAS ID
1006807
Contact name
Fiona Ryan
Contact email
Sponsor organisation
GH Research Ireland Limited
Eudract number
2022-000574-26
Clinicaltrials.gov Identifier
Research summary
GH Research wants to have a better understanding about how effective a drug called GH001 is in patients suffering from depression that has not responded well to medication (treatment-resistant depression (TRD)).
GH001 is a drug that can temporarily change your perceptions, emotions and give a consciousness-expanding effect, which can result in an overwhelming sense of unity and connectedness, often described as “oneness with the universe”. Such a feeling may lead to a long-lasting improvement of depressive symptoms and elevation of depressed mood. This effect makes GH001 possibly suitable for the treatment of psychiatric diseases such as depression.
Participants will only be given doses shown to be safe in previous trials with GH001. No serious side-effects have been reported during the previous trials with GH001.
80 people will be enrolled in the study. Suitability will be assessed during the Screening Period which lasts up to 6 weeks. The study has 2 parts. Part 1 is a 1-week double-blind (DB) part where patients will receive either GH001 or placebo (hereafter called the study medication). They will have a 50% chance of receiving either GH001 or placebo. The study medication is administered as a vapor via inhalation during a single clinic visit using an individualized dosing regimen (IDR). Up to 3 increasing doses may be administered depending on the participants response. The onset of the psychoactive effects is expected within 30 seconds, with an overall duration of usually less than 30 minutes. After the clinic visit (Day 0) participants will be contacted by phone on Day 1 and will attend the study site on Day 7 of the DB part of the study. Participants will then move into the open-label extension part of the study (Part 2) and will attend the study site on Day 14 and monthly for 6 months. GH001 IDRs will be administered if depressive symptoms continue to occur or recur. If needed, up to 5 GH001 IDRs can be administered during this period.
REC name
East of England - Essex Research Ethics Committee
REC reference
23/EE/0105
Date of REC Opinion
18 Aug 2023
REC opinion
Further Information Favourable Opinion