Clinical TrialTreatment-Resistant Depression (TRD)KetaminePlaceboTerminated

Intranasal Ketamine vs Midazolam for TRD: Double-Blind Parallel Pilot RCT (Gálvez 2018, Thompson Institute / Otago)

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.

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Target Enrollment
10 participants
Study Type
Phase II interventional
Design
Randomized, double Blind

Detailed Description

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.

Study Arms & Interventions

Ketamine

experimental

A 4-week course of eight intranasal ketamine treatments (100 mg per treatment, administered as 10 separate sprays).

Interventions

  • Ketamine100 mg
    via Intranasal• three times a week for 2 weeks, then weekly for 2 weeks• 8 doses total

    Each treatment consisted of 10 separate IN sprays, self-administered 5 min apart (later modified to 5 min intervals between sprays due to tolerability).

Midazolam

active comparator

A 4-week course of eight intranasal midazolam treatments (4.5 mg per treatment, administered as 10 separate sprays).

Interventions

  • Placebo4.5 mg
    via intranasal• three times a week for 2 weeks, then weekly for 2 weeks• 8 doses total

    Each treatment consisted of 10 separate IN sprays.

Study Details

Locations

New Zealand

Related Publications

PaywallindividualPrimary

Repeated intranasal ketamine for treatment-resistant depression - the way to go? Results from a pilot randomised controlled trial

In a halted double‑blind pilot RCT of repeated intranasal 100 mg ketamine for treatment‑resistant depression, acute cardiovascular, psychotomimetic and neurological side effects and marked interindividual variability in ketamine/norketamine absorption produced poor tolerability and impractical administration, with no clear efficacy advantage over midazolam. Using the formulation and delivery device tested, intranasal ketamine was not a viable treatment approach, although no hepatic, cognitive or urinary adverse changes were observed.

Published
Journal
Journal of Psychopharmacology
Authors
Huggins, C., Glue, P., Martin, D., Somogyi, A. A., Alonzo, A., Rodgers, A., Mitchell, P. B., Loo, C.