This ongoing EEA CTA trial (n=128) conducted in the Netherlands by the Academic Medical Center (AMC) investigates the efficacy of intranasal ketamine in addressing acute suicidality (SI).
Referred to as the Ketamine Trial Amsterdam (KETA), the trial involves a double-blind, randomized, placebo-controlled design. The primary objective is to examine the anti-suicidal effects of a single dose of intranasal ketamine in acutely suicidal subjects, assessing changes in suicidality scores on the Beck Scale for Suicide Ideation (BSSI). Secondary objectives include safety, antidepressant effects, time-course of effects, and neurobiological markers measured through various imaging techniques and blood samples.
The trial involves adults aged 18-70, excludes those with specific conditions, and has a duration of approximately 3 years. The last follow-up call for the last subject is expected one week after their visit. The trial received authorization from the Competent Authority on November 6, 2018, and a favourable ethics committee opinion on July 23, 2018.
Trial Details
The ongoing Ketamine Trial Amsterdam (KETA) in the Netherlands, sponsored by the Academic Medical Center (AMC), is a double-blind, placebo-controlled study investigating intranasal ketamine's efficacy in treating acute suicidality (n=128). The trial aims to assess anti-suicidal effects and neurobiological markers over approximately 3 years. Authorized by the Competent Authority on November 6, 2018, with a favourable ethics committee opinion on July 23, 2018.NCT Number 2015-004745-70