The effect of intranasal ketamine on suicidality in severely depressed and suicidal patients. Randomized, placebo-controlled study

This Phase IV trial (n=72), conducted by the Department of Psychiatry, Helsinki University Central Hospital in Finland, is a placebo-controlled study investigating the effect of intranasal ketamine on suicidality in severely depressed (MDD) and suicidal patients (SI).

The trial involves adults aged 18-64 with severe depression and a suicidal ideation scale (SSI) score of at least 6. The patients, awaiting electroconvulsive therapy (ECT), will receive ketamine or a placebo. Exclusion criteria include substance abuse, unstable personality disorders, and certain psychotic disorders.

The primary endpoint is a minimum 6-point reduction on the SSI scale one day after treatment. The trial, initiated on April 30, 2015, aims to assess the impact of ketamine on suicidality and mood in this specific patient population. The trial is authorized by the Competent Authority, with a favourable opinion from the Ethics Committee, and it is expected to conclude in October 2024.

(Note: The trial’s design is classified as a therapeutic use (Phase IV) with a randomized, double-blind, placebo-controlled approach involving two treatment arms. The trial is single-site and spans 1 year, 6 months in the Member State concerned, with a planned inclusion of 72 adult subjects.)

EudraCT Number 2014-002451-26 and Protocol Code Number 538264464328

Topic Suicidality Depression
Compound Ketamine Placebo
Country Finland
Visit trial
Status Active, not recruiting
Results Published No
Start date 30 April 2015
End date 30 April 2024
Phase Phase IV
Design Blinded
Type Interventional
Generation First
Participants 72
Sex All
Age 18- 64
Therapy Yes

Trial Details

This ongoing clinical trial, led by the Department of Psychiatry at Helsinki University Central Hospital, investigates the effects of intranasal ketamine on suicidality in severely depressed and suicidal adults (ages 18-64). The study, initiated on April 30, 2015, involves participants awaiting electroconvulsive therapy. The primary goal is to observe a minimum 6-point reduction in the suicidal ideation scale (SSI) one day after treatment. The trial is scheduled to conclude in October 2024, with authorization from the Competent Authority and a favourable opinion from the Ethics Committee.

NCT Number 2014-002451-26

Sponsors & Collaborators

University of Helsinki
The Korpi Lab at the University of Helsinki is focused on understanding the neurochemical basis of behaviour and has done so using LSD.

Data attribution

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