Ketamine for the treatment of depressive and negative symptoms in patients with schizophrenia: a randomized controlled cross-over pilot study

This randomised controlled cross-over pilot study (n=20) investigates the efficacy of esketamine in treating depressive and negative symptoms in patients (ages 18-64) with schizophrenia, schizophreniform disorder, or schizoaffective disorder.

Conducted by the Medical University of Vienna, the trial aims to demonstrate the superiority of esketamine over a placebo, with secondary objectives including assessing effects on positive symptoms. The treatment involves intravenous administration of Ketanest S (25 mg/ml) and Dibondrin (30 mg), serving as the active and placebo comparator, respectively.

The primary outcome measures are changes in the Scale for the Assessment of Negative Symptoms (SANS) and Montgomery-Asberg Depression Rating Scale (MADRS). The trial, authorised by the Austrian Competent Authority and with a favourable Ethics Committee opinion, began on September 7, 2021, and is expected to conclude in approximately three years.

Topic Schizophrenia Depression
Compound Placebo Ketamine
Country Austria
Visit trial
Status Active, not recruiting
Results Published No
Start date 07 September 2021
End date 31 December 2025
Phase Phase III
Design Blinded
Type Interventional
Generation Second
Participants 20
Sex All
Age 18- 64
Therapy Yes

Trial Details

This ongoing trial by the Medical University of Vienna is exploring the effectiveness of esketamine in treating depressive and negative symptoms in schizophrenia patients (ages 18-64). With 20 participants, the study uses a randomised controlled cross-over design, comparing Ketanest S (25 mg/ml) to a placebo, Dibondrin (30 mg). The focus is on changes in the Scale for the Assessment of Negative Symptoms (SANS) and Montgomery-Asberg Depression Rating Scale (MADRS). Approved by the Austrian Competent Authority, with a positive Ethics Committee opinion, the trial began on September 7, 2021, and is expected to last about three years.

NCT Number 2019-004489-16

Sponsors & Collaborators

Medical University of Vienna
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Data attribution

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