Efficacy and feasibility of intranasal ketamine on acute suicidality, a double blind randomized placebo-controlled trial (Ketamine Trial for Acute suicidality, KETA)

This double-blind, placebo-controlled trial (n=112) conducted by the University Medical Centre Groningen in the Netherlands aims to explore the efficacy and feasibility of intranasal ketamine (75mg) in addressing acute suicidality (SI).

The trial, known as the “Ketamine Trial for Acute Suicidality” (KETA), involves a single dose of intranasal ketamine (75 mg) compared to a placebo (4.0 mg intranasal midazolam). The primary endpoint is the change in suicidality scores on the Beck Scale for Suicide Ideation (BSSI) 180 minutes after intervention. Secondary objectives include assessing safety, antidepressant effects, time-course of effects, number of suicides, and neurobiological markers.

The trial involves adults aged 18-70 and is currently ongoing, with an estimated duration of three years. The study is sponsored by the University Medical Center Groningen, a non-commercial entity, with support from ZonMw, a Dutch organization. The trial received authorization from the Competent Authority on July 7, 2021, and favorable ethics committee opinion on June 8, 2021.

Topic Suicidality
Compound Ketamine Placebo
Country Netherlands
Visit trial
Status Active, not recruiting
Results Published No
Start date 08 June 2021
End date 31 December 2024
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 112
Sex All
Age 18- 70
Therapy Yes

Trial Details

This ongoing double-blind trial (n=112) by the University Medical Center Groningen in the Netherlands investigates the potential of intranasal ketamine (75 mg) for acute suicidality compared to a placebo. The primary endpoint is the change in Beck Scale for Suicide Ideation scores 180 minutes post-intervention. The trial, named "Ketamine Trial for Acute Suicidality" (KETA), spans three years and is supported by ZonMw. Approved by the Competent Authority in July 2021, it holds favorable ethics committee opinion since June 2021.

NCT Number 2020-002905-24

Sponsors & Collaborators

University of Groningen
The University of Groningen, established in 1614, is a prestigious institution that ranks among the world's top universities. It has taken a pioneering role in the interdisciplinary research of psychedelics, harnessing its rich academic heritage and a forward-looking approach to exploring the potential of psychedelic substances in treating various mental health conditions.

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