This unregistered trial (n=10) was a double-blind, placebo-controlled pilot study of intranasal ketamine for treatment-resistant depression in patients, which was terminated early due to poor tolerability and significant acute adverse effects.
This synthetic trial has been added to our database because a psychedelic paper (about a clinical trial) references this trial, but no (live) registration can be found.
The study investigated the feasibility, safety, and efficacy of a four-week course of eight intranasal ketamine treatments (100 mg) compared to an active control of intranasal midazolam (4.5 mg). Participants were individuals with treatment-resistant depression who had failed at least two antidepressant treatments.
The trial was terminated early after five participants were enrolled due to significant acute cardiovascular, psychotomimetic, and neurological side effects. Researchers noted that the specific drug formulation and delivery device contributed to poor tolerability and variable absorption.
A 4-week course of eight intranasal ketamine treatments (100 mg per treatment, administered as 10 separate sprays).
Each treatment consisted of 10 separate IN sprays, self-administered 5 min apart (later modified to 5 min intervals between sprays due to tolerability).
A 4-week course of eight intranasal midazolam treatments (4.5 mg per treatment, administered as 10 separate sprays).
Each treatment consisted of 10 separate IN sprays.