Ketamine-assisted psychotherapy for treatment-resistant depression in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial uses a structured Ketamine-Assisted Psychotherapy (KAP) approach in a medically supervised setting to treat adults with persistent or treatment-resistant depression. Participants undergo comprehensive assessments, medical screening, preparation sessions, ketamine infusions, and post-session integration therapy. Safety monitoring, vital signs, and psychiatric oversight are integral to the protocol. The study aims to observe clinical effectiveness and the subjective therapeutic impact of KAP in routine mental healthcare.

Why it matters

Who can join: the full rules

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's running

• Senz
  Doorn, Utrecht, Netherlands Recruiting

Study contacts

• Principal investigator: Rutger Engels — Senz
• Study coordinator: Rutger Engels, dr
• Email: r.engels@senzggz.nl
• Phone: +31 343 235300

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.