Ketamine study
Key facts
- Where
- Vienna, AusztriaSee the site
- Phase
- 3. fázis
Could this be for you?
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 Ausztria
- Medical University of ViennaVienna, AusztriaTaking people
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?
Trial details
- Who runs it
- Medical University Of Vienna
- Trial code
- EU 2024-519097-39-01
- Record updated
- 2025. február 27.
- Original description
To show that esketamine is superior to placebo in reducing negative and depressive symptoms in patients with a psychotic disorderRead full original descriptionShow less
Ketamine for the treatment of depressive and negative symptoms in patients with schizophrenia: a randomized controlled cross-over pilot study.
To show that esketamine is superior to placebo in reducing negative and depressive symptoms in patients with a psychotic disorder
Inclusion: 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).
Exclusion: 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.