2024-519097-39-01RecruitingPhase 3
Ketamine study
Ketamine for the treatment of depressive and negative symptoms in patients with schizophrenia: a randomized controlled cross-over pilot study.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 27 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To show that esketamine is superior to placebo in reducing negative and depressive symptoms in patients with a psychotic disorder
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 28 Jan 2025
- Start date
- 23 Jun 2022
- Lead sponsor
- Medical University Of Vienna
- Diseases
- Schizophrenia
- EU CT number
- 2024-519097-39-01
- EudraCT number
- 2019-004489-16
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 20
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current antidepressant treatment (or treatment up to two weeks prior to inclusion) with an irreversible MAO-inhibitor (e.g. tranylcypromine)
Other illness
- 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
Lab values
- Severe or unstable medical or neurologic disorders or clinically significant abnormality on laboratory screening results
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Vienna | Vienna | Austria | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.