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

NCT07706478 | Recruiting

• 1 other identifier: 24-343/DB/02
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Treatment Resistant Depression

Keywords

KAP; TRD; Depression; IV ketamine

Outcome Measures

Primary Outcomes (1)

• Beck Depression Inventory

  depression self-report measure. Zero is equivalent to no depression and 64 indicates the highest score on depression.

  baseline/pre-intervention/post-intervention (end of treatment)/3months after post-intervention

Secondary Outcomes (1)

• Montgomery-Åsberg Depression Rating Scale

  baseline/pre-intervention/post-intervention (end of treatment)/3months after post-intervention

Study Arms (1)

adults with treatment resistant depression

MADRS depression score above the clinical cut-off. Insufficient response to at least two antidepressant treatments and one evidence-based form of psychotherapy, or completion of at least three consecutive treatment steps according to the Dutch multidisciplinary guideline for depression.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Clients of Senz with TRD who are eligible for IV ketamine treatment (KAP)

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

Sponsors & Collaborators

• Senz: lead
• Radboud University Medical Center: collaborator

Study Sites (1)

SENZ

Doorn, Utrecht, 3941ZS, Netherlands

RECRUITING

Related Links

• website clinic

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Rutger Engels

  Senz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rutger Engels, dr

CONTACT

+31 343 235300; r.engels@senzggz.nl

karlijn kindt, dr

CONTACT

+31343 235300; k.kindt@senzggz.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: July 15, 2026
• Study Start: June 1, 2025
• Primary Completion (Estimated): January 1, 2033
• Study Completion (Estimated): January 1, 2033
• Last Updated: July 15, 2026

Record last verified: 2026-07

Locations

NL (1)