A single day of treatment with an inhaled synthetic formulation of mebufotenin (GH001) significantly reduced depression symptoms in adults with treatment-resistant depression compared to placebo. In a randomized, double-blind trial of 81 patients, those receiving up to three escalating doses of GH001 showed an average 15.5-point greater improvement on the Montgomery-Åsberg Depression Rating Scale by day 8 than those on placebo. Remission rates were 57.5% for GH001 and 0% for placebo. No severe or serious adverse events occurred. The findings suggest GH001 may be a rapid-acting, well-tolerated treatment option for treatment-resistant depression.
In a small open-label trial, ten women with postpartum depression received up to three escalating doses of inhaled GH001 (a synthetic form of 5-MeO-DMT) on a single day. Depressive symptoms, measured on the Montgomery-Asberg Depression Rating Scale, dropped by an average of 35.4 points from a baseline of 36.7 by day 8, and all participants met criteria for both response and remission. Improvements were first noted two hours after the final dose. The treatment was well tolerated, with only mild to moderate side effects, most commonly headache. These preliminary findings suggest GH001 may produce rapid and substantial antidepressant effects in postpartum depression, but larger controlled trials are needed.