GH001-BD-202
Research type
Research Study
Full title
A Phase 2 Clinical Trial of GH001 in Patients with Bipolar II Disorder and a Current Major Depressive Episode (GH001-BD-202)
IRAS ID
1009141
Contact name
Jasmin Russ
Contact email
Sponsor organisation
GH Research Ireland Limited
Eudract number
2021-006861-39
Research summary
The purpose of this study is to investigate the effectiveness and the safety and tolerability of the study drug GH001 in patients with bipolar II disorder that are experiencing a major depressive episode.
GH001 is a compound that is being developed for the treatment of depression and other psychiatric diseases. It is inhaled and can temporarily change your perceptions, emotions and consciousness. 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.
GH001 has been administered to healthy volunteers and patients before.
The dosage regimen of GH001 that will be investigated in the present study is based on results of already completed clinical studies of GH001 in healthy volunteers and patients with a depression that is resistant to treatment. Up to three doses may be given. These doses were shown to be safe in previous studies with GH001. No serious side-effects have been reported during the previous studies with GH001. With this study, more information will be collected about the safety of the GH001 dosing regimen in patients with bipolar II disorder during a major depressive episode.REC name
London - Fulham Research Ethics Committee
REC reference
23/LO/1003
Date of REC Opinion
6 Feb 2024
REC opinion
Further Information Favourable Opinion