Inhaled Mebufotenin (GH001) for Adult Patients With Postpartum Depression: A Phase 2a Open-Label Clinical Trial.

What was studied

This trial tested GH001, a drug that people breathe in. It holds mebufotenin, also called 5-MeO-DMT. The trial was in women with depression that began around giving birth. The women were aged 18 to 45. Their depression scores were 28 or more at the start. Each woman got up to 3 rising doses on day 1. The doses were 6, 12 and 18 mg. It was an open-label trial. The main goal was the change in a depression score by day 8.

What they found

10 women took part in this phase 2a trial. Their mean depression score at the start was 36.7. By day 8, the score fell by a mean of 35.4 points. All women had a response and reached remission by day 8. This was first seen 2 hours after the last dose on day 1. No serious side effects were reported. All side effects were mild or moderate. Headache was the most common one.

What it means for patients

The authors say GH001 eased depression fast and clearly in these women. They also say its safety seemed acceptable. Other measures in the trial got better at the same time. This trial was an early check of whether the idea may work.

Why it is not certain yet

Only 10 women were in the trial. The trial was open-label. The abstract gives results only up to day 8. Early-phase trials are a first look, not final proof.

Source

Inhaled Mebufotenin (GH001) for Adult Patients With Postpartum Depression: A Phase 2a Open-Label Clinical Trial.

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