Taking people in AustriaPhase 3
Esketamine for low mood and withdrawal symptoms in schizophrenia
Tests esketamine against placebo for negative and depressive symptoms in people with psychotic disorders.
Key facts
- Who runs it
- Medical University Of Vienna
- Where
- Vienna, AustriaSee the site
- Registry title
- Ketamine study
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 20 people, planned
- Started
- 23 Jun 2022
- Planned end
- 7 Nov 2025
- Type of study
- Interventional
- Record updated
- 27 February 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with schizophrenia who have negative or depressive symptoms and take stable medication. It tests esketamine against placebo.
- Age
- 18 to 65 years (the registry also lists a maximum age of 64 years)
- Sex
- All sexes can join.
- Disease stage
- Schizophrenia diagnosed by DSM-5 (SCID 5), with a Brief Negative Symptom Scale (BNSS) score of at least 39, or a Montgomery-Åsberg Depression Rating Scale (MADRS) score of at least 22.
- Earlier treatment
- Must have been on stable psychiatric medication for at least four weeks before joining. Cannot have had an irreversible MAO-inhibitor antidepressant (for example tranylcypromine) in the last two weeks.
Main reasons for not taking part
- Severe or unstable medical or neurological illness
- Heart problems such as a past heart attack, angina or an abnormal ECG
- Untreated or unstable high blood pressure
- Pregnancy or breastfeeding
- Acute suicidal or homicidal thoughts
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- DSM-5 diagnosis of schizophrenia according to SCID 5
- Minimum Brief Negative Symptom Scale (BNSS (1) score of 39 (at least moderate severity across all items) or
- Minimum score of 22 on the Montgomery-Åsberg Depression Rating Scale (MADRS) (2)
- Age: 18 to 65 years
- Ability to provide written informed consent
- On stable psychopharmacological medication for at least four weeks prior to study inclusion
- Female patients of childbearing potential need to utilize a proper method of contraception (pill, vaginal ring, hormonal patch, intrauterine device, cervical cap, condom, contraceptive injection, diaphragm)
Who cannot take part
- Current antidepressant treatment (or treatment up to two weeks prior to inclusion) with an irreversible MAO-inhibitor (e.g. tranylcypromine)
- Presence of ferromagnetic metal in the body or heart pacemaker
- History of myocardial infarction, angina pectoris, or paroxysmal hypertensive states
- Untreated or unstable arterial hypertension
- Severe or unstable medical or neurologic disorders or clinically significant abnormality on laboratory screening results
- Clinically relevant abnormalities in the electro-cardiogram (ECG)
- Established diagnosis of advanced arteriosclerosis or hyperthyroidism
- Intolerance to Ketanest® or Dibondrin®
- Pregnancy or lactation
- Acute suicidal or homicidal ideation
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Austria
- Medical University of ViennaVienna, AustriaTaking people
About the trial
What the trial wants to find out
To show that esketamine is superior to placebo in reducing negative and depressive symptoms in patients with a psychotic disorder
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- Ketamine for the treatment of depressive and negative symptoms in patients with schizophrenia: a randomized controlled cross-over pilot study.
- Plain-language title
- Esketamine for low mood and withdrawal symptoms in schizophreniaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Fit questions
- Built from 2024-519097-39-01, who can take part
- Record updated
- 27 February 2025