Investigation of antidepressant efficacy of oral ketamine treatment

This double-blind, placebo-controlled trial (n=60) aimed to investigate the antidepressant efficacy of oral ketamine treatment in patients experiencing a major depressive episode within the scope of major depressive or bipolar disorder (MDD/BD).

Conducted by the Medical University of Vienna in Austria, the trial spanned a duration of approximately 2 years. The primary objective was to assess the antidepressant efficacy of oral ketamine in a randomized and controlled study design, with secondary objectives focusing on tolerability and clinical utility.

The trial involved adults aged 18 to 64, diagnosed with a major depressive episode. Notable exclusion criteria included recent initiation of antidepressant treatment and substance abuse history.

The trial utilized two treatment arms, involving the administration of oral ketamine and a comparator, midazolam hydrochloride. The primary endpoint was measured using the Montgomery-Åsberg Depression Rating Scale (MADRS) before and after treatment sessions. Secondary endpoints included the Clinician Administered Dissociative States Scale (CADSS) evaluation.

The trial concluded on October 13, 2021, with authorized Competent Authority Decision and favorable Ethics Committee Opinion received.

Topic Depression Bipolar Disorder
Compound Ketamine
Country Austria
Visit trial
Status Completed
Results Published No
Start date 24 October 2016
End date 13 October 2021
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 60
Sex All
Age 18- 64
Therapy Yes

Trial Details

This completed double-blind, placebo-controlled trial (n=60) by the Medical University of Vienna assessed the antidepressant efficacy of oral ketamine in major depressive episodes. Conducted in Austria, the trial spanned around 2 years, involving adults (18-64) with specific inclusion and exclusion criteria. It employed two treatment arms, using oral ketamine and midazolam hydrochloride as a comparator. Primary and secondary endpoints included the Montgomery-Åsberg Depression Rating Scale (MADRS) and Clinician Administered Dissociative States Scale (CADSS). The trial concluded on October 13, 2021, with authorized Competent Authority Decision and favorable Ethics Committee Opinion.

NCT Number 2016-002068-14

Data attribution

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