NCT07706478Recruiting
Working Mechanisms and Effectiveness of IV Ketamine-assisted Psychotherapy on Depression in TRD Clients
Effectiveness and Underlying Mechanisms of an Innovative Treatment Program for Persistent Mood and Anxiety Conditions
Source: ClinicalTrials.gov · Last updated 15 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 120 (estimated)
- First submitted
- 3 Jun 2026
- Start date
- 1 Jun 2025
- Primary completion date
- Jan 2033
- Lead sponsor
- Senz
- Diseases
- Depression
- NCT number
- NCT07706478
What you commit to
- Study type: Observational
- Planned participants: 120
- From 1 Jun 2025 to the primary completion date, Jan 2033
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Current substance use disorder or recent illicit drug use
- Substance use disorder not in remission for at least 3 months
- 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
Other
- Inability to abstain from alcohol for 24 hours before and after treatment
- Acute suicidality
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SENZ Coordinator of this site? Confirm its status | Doorn | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.