Phase 2 Clinical Trial of GH001 in Postpartum Depression
This is a single-arm, open-label Phase II clinical trial (n=15) investigating the anti-depressive effects of GH001 in postpartum depression (PPD) patients.
Details
Multicentre, open-label, single-group Phase 2 study of inhaled GH001 (5-MeO-DMT) in female participants with postpartum depression; individualised dosing (up to three inhaled doses in one day).
Up to three escalating inhaled doses (6, 12, 18 mg) are given within a single day; subsequent doses are administered only if a peak experience (PE) is not achieved at the prior dose.
Key eligibility: females 18–45 years, BMI 18.5–35 kg/m2, diagnosis of PPD; exclusions include family history of bipolar/psychotic disorders and pregnancy.
Planned/actual enrolment from registry indicates 10 participants to date; study sites include Amsterdam UMC and multiple UK clinical research centres.