Working Mechanisms and Effectiveness of IV Ketamine-assisted Psychotherapy on Depression in TRD Clients
Recruiting · NCT07706478 · Observational (researchers observe without assigning treatment) · Lead sponsor: Senz
View the official record on ClinicalTrials.gov →What this trial is about
Ketamine-Assisted Psychotherapy (KAP) is an innovative treatment that combines intravenous ketamine with psychotherapy in a carefully monitored clinical setting. At Senz, this treatment is being evaluated in an open-label clinical trial for individuals with persistent depression who have not responded sufficiently to previous treatments. The combination of ketamine, psychological support, and integration sessions aims to promote emotional processing, psychological flexibility, and lasting therapeutic change.
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Adults (18 years and older)
- TRD
- A MADRS score above the established clinical cut-off, indicating clinically significant depressive symptoms
- Insufficient response to at least two adequate antidepressant treatment trials and one evidence-based psychotherapy, or failure to achieve adequate improvement following at least three consecutive treatment steps in accordance with the Dutch Multidisciplinary Guideline for Depression
Exclusion criteria
- Current substance use disorder or recent illicit drug use
- Substance use disorder not in remission for at least 3 months
- Inability to abstain from alcohol for 24 hours before and after treatment
- Acute suicidality
- Current or past psychotic disorder
- Significant neurological disorders (e.g., epilepsy, elevated intracranial pressure)
- Uncontrolled hypertension or medical conditions associated with increased cardiovascular or cerebrovascular risk (e.g., aneurysms, recent myocardial infarction or intracerebral hemorrhage)
- Significant bladder disease (e.g., cystitis)
- Severe hepatic impairment
- Pregnancy, breastfeeding, or ongoing IVF treatment
- Extreme underweight or obesity where treatment is deemed medically unsafe Inability to arrange an accompanying adult for transport and support after treatment
Where it is running
1 location listed.
- SENZ - Doorn, Utrecht, Netherlands