Investigating the effects of ketamine on brain activity in depression
Imaging Neural Correlates of Antidepressant Action of Ketamine Stereoisomers Using Pharmacological PET/MR Imaging and Metabolite Analysis.
This study is testing how two forms of ketamine affect brain activity in people with depression to see which one works better.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 65 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Vienna) |
| Trial ID | NCT04587778 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to explore the pharmacodynamic differences between racemic ketamine and esketamine in patients with Major Depressive Disorder using advanced imaging techniques like PET/MR. It includes a pilot phase with healthy volunteers to assess the pharmacokinetics and behavioral effects of intravenous ketamine. Participants will undergo a randomized, placebo-controlled, double-blind, cross-over design where they will receive either S-ketamine or a placebo during imaging sessions. The study seeks to optimize scanning procedures and gather data on how these substances affect brain activity.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 to 55 who are right-handed and willing to participate in the study.
Not a fit: Patients with current or historical psychiatric or neurological diseases, or those with contraindications for MRI, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment options for patients with Major Depressive Disorder.
How similar studies have performed: Previous studies have shown promise in using ketamine for depression, but this specific approach using PET/MR is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * General health based on medical history, physical examination and structured clinical interview for the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) (SCID) * Age 18 to 55 years * Right-handedness (due to potential lateralization effects of lefthanded subjects) * Willingness and competence to sign the informed consent form. Exclusion Criteria: * Current or history of psychiatric or neurological disease * Current medical illness requiring treatment * Pregnancy or current breastfeeding * Current or former substance abuse * Diagnosis of an Axis-1 psychotic disorder in a first-degree relative * Any contraindication for MRI (e.g., MR incompatible implants, etc.) including dental implants causing signal artifacts * For subjects participating in earlier studies using ionizing radiation, the total radiation exposure of 30 millisievert (mSv) over the last 10 years must not be exceeded, as specified in the Austrian legislation on radiation protection (www.ris.bka.gv.at). Accordingly, body weight \>100kg is an exclusion criterion (5.1 Megabequerel (MBq)/kg \* 100kg \* 0.019 mSv/MBq\* 0.885 = 8.58 mSv per scan, the factor 0.885 is considered due to continuous radioligand infusion, see PET scanning). * Failure to comply with the study protocol or to follow the instruction of the investigating team.
Where this trial is running
Vienna
- Medical University of Vienna — Vienna, Austria (Recruiting)
Study contacts
- Study coordinator: Rupert Lanzenberger, Prof.
- Email: rupert.lanzenberger@meduniwien.ac.at
- Phone: 004314040035760
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.