Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05800860 | A Trial of GH001 in Patients With Treatment-resistant Depression | PHASE2 | COMPLETED | 81 | — | — | May 24, 2023 | Mar 11, 2025 | May 31, 2025 | 11 | Czechia, Germany +4 |
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 ...