Working Mechanisms and Effectiveness of IV Ketamine-assisted Psychotherapy on Depression in TRD Clients

Recruiting now

Conditions studied: Treatment Resistant Depression

In brief

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.

Key facts

Study ID

NCT07706478

Run by

Senz

People needed

120

Starts

2025-06-01

Expected to finish

2033-01-01

Last updated by the study team

2026-07-15

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• SENZ — Doorn, Utrecht, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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