GH001-PPD-203
Research type
Research Study
Full title
A phase 2a clinical trial of GH001 in patients with postpartum depression
IRAS ID
1005432
Contact name
Elisabeth Sterner-Pongratz
Contact email
Sponsor organisation
GH Research Ireland Limited
Eudract number
2021-006879-42
Clinicaltrials.gov Identifier
Research summary
GH Research wants to have a better understanding about how a drug called GH001 works in patients that are suffering from postpartum depression, how effective this trial drug can be and how well patients can tolerate it. GH Research also wants to have a better understanding about the way the body deals with trial drug. This is also known as pharmacokinetics (PK). In this study, it will also be assessing patient´s safety and how well the patient can deal with the trial drug when an individualized dosing regimen is used.
GH001 is a drug that is being developed for the treatment of depression which can temporarily change your perceptions, emotions and consciousness. It is usually inhaled and the substance can give a unique consciousness-expanding effect, described as a feeling of “loss of ego”, which can result in an overwhelming sense of unity and connectedness, often described as “oneness with the universe”. Such a feeling has been described to lead to a long-lasting ease of emotional tension and an overall more positive perspective on life. This effect makes GH001 possibly suitable for the treatment of psychiatric diseases such as depression.
The individualized dosing regimen applied in this clinical trial is based on results of already completed clinical trials of GH001 in healthy volunteers and patients with a depression that is resistant to treatment. Participants in the present study will only be given individualized doses shown to be safe in previous trials with GH001. No serious side-effects have been reported during the previous trials with GH001. With this study, more information will be collected about the safety of the different doses of GH001 in patients with postpartum depression.REC name
East of England - Essex Research Ethics Committee
REC reference
22/EE/0121
Date of REC Opinion
15 Jul 2022
REC opinion
Further Information Favourable Opinion