Clinical and neurobiological predictors of response to ketamine: towards personalized treatment of depression

This open-label trial (n=40) investigated the predictors of response to ketamine in treating moderate to severe depression without psychotic symptoms.

Conducted by the National Institute of Mental Health in the Czech Republic, the study aimed to identify whether ketamine responders differ from non-responders in baseline parameters of anhedonia.

The primary endpoint was the correlation between the change in anhedonia after ketamine administration and the reduction in depressive symptomatology. Secondary objectives included comparing baseline plasmatic levels of specific metabolites, assessing electrophysiological correlates, estimating the influence of demographic and clinical variables, and evaluating cognitive processing speed.

The trial involved adults aged 18 to 65 and employed an open-label design. The study received favorable opinions from the Competent Authority and Ethics Committee. The trial duration was approximately four years, concluding on April 14, 2022.

Topic Depression
Compound Ketamine
Country Czech Republic
Visit trial
Status Completed
Results Published No
Start date 16 July 2018
End date 14 April 2022
Phase Phase III
Design Open
Type Interventional
Generation First
Participants 40
Sex All
Age 18- 65
Therapy Yes

Trial Details

This completed open-label trial, conducted in the Czech Republic by the National Institute of Mental Health, involved 40 adults aged 18 to 65 with moderate to severe depression. It aimed to identify predictors of ketamine response, focusing on anhedonia parameters. The trial assessed correlations between anhedonia changes and depressive symptom reduction after ketamine administration. Secondary objectives included biomarker evaluations and the impact of demographic variables. Authorized by the Competent Authority and Ethics Committee, the trial concluded on April 14, 2022, after a four-year duration.

NCT Number 2018-001539-39

Sponsors & Collaborators

National Institute of Mental Health
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Data attribution

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