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Ketamine study
EU CTIS ID: 2024-519097-39-01
What this study is testing
To show that esketamine is superior to placebo in reducing negative and depressive symptoms in patients with a psychotic disorder
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Severe or unstable medical or neurologic disorders or clinically significant abnormality on laboratory screening results
- Presence of ferromagnetic metal in the body or heart pacemaker
- Clinically relevant abnormalities in the electro-cardiogram (ECG)
- History of myocardial infarction, angina pectoris, or paroxysmal hypertensive states
- Untreated or unstable arterial hypertension
- Established diagnosis of advanced arteriosclerosis or hyperthyroidism
See the full eligibility criteria
- 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)
- Severe or unstable medical or neurologic disorders or clinically significant abnormality on laboratory screening results
- Presence of ferromagnetic metal in the body or heart pacemaker
- Clinically relevant abnormalities in the electro-cardiogram (ECG)
- History of myocardial infarction, angina pectoris, or paroxysmal hypertensive states
- Untreated or unstable arterial hypertension
- Established diagnosis of advanced arteriosclerosis or hyperthyroidism
- Intolerance to Ketanest® or Dibondrin®
- Pregnancy or lactation
- Current antidepressant treatment (or treatment up to two weeks prior to inclusion) with an irreversible MAO-inhibitor (e.g. tranylcypromine)
- Acute suicidal or homicidal ideation
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.