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GH001 · 1 trial · 1 indication
The assessment is done with the MADRS, a diagnostic questionnaire with ten items for measuring the severity of depressive episodes in patients with mood disorders. A higher MADRS score indicates more severe depression, and each item is scored from 0 to 6. The overall score ranges from 0 to 60.
| Arm | Type | Description |
|---|---|---|
| GH001 - Part 1 | EXPERIMENTAL | GH001 is administered via inhalation, as an IDR consisting of up to 3 increasing doses of GH001 (6 mg, 12 mg, and 18 mg), on a single day. The second and third doses are only administered if the patient did not achieve intense psychoactive effects (a peak experience \[PE\]) at the previously administered dose. |
| Placebo - Part 1 | PLACEBO_COMPARATOR | Placebo is administered via inhalation, as an IDR consisting of up to 3 doses of Placebo, on a single day. The second and third doses are only administered if the patient did not achieve intense psychoactive effects (a PE) at the previously administered dose. |
| Open-Label Extension (OLE) - Part 2 | OTHER | Patients can receive up to five GH001 IDRs as needed during the OLE based on the patient's clinical response. |
| Name | Type | Description |
|---|---|---|
| GH001 | DRUG | GH001 administered via inhalation |
| Placebo | DRUG | Placebo administered via inhalation |
Main Inclusion Criteria: 1. Is in the age range between 18 and 64 years (inclusive) at the time of informed consent; 2. Meets the trial criteria for TRD as assessed by a study psychiatrist: 1. Meets the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) criteria for single-episode ...
GH001 is an investigational small molecule being developed for the treatment of treatment-resistant depression. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
GH001 is being developed by GH Research PLC, a biopharmaceutical company listed on the stock exchange under the ticker GHRS.
GH001 is in Phase 2 clinical development for treatment-resistant depression. It has completed one Phase 2 trial and is not yet approved for commercial use.
GH001 has been studied in a completed Phase 2 clinical trial with the identifier NCT05800860. This trial enrolled 81 participants with treatment-resistant depression and was conducted in Czechia, Germany, Ireland, Netherlands, Poland, and Spain.
GH001 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for treatment-resistant depression, meaning it has not yet received regulatory approval for any use.