About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Clients of Senz with TRD who are eligible for IV ketamine treatment (KAP)
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Beck Depression Inventory
depression self-report measure. Zero is equivalent to no depression and 64 indicates the highest score on depression.
Secondary outcomes
Montgomery-Åsberg Depression Rating Scale
depression clinician report. Zero is equivalent to no depression and 60 indicates the highest score on depression.
Sponsors and contacts
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Senz
Lead sponsor
Radboud University Medical Center
Collaborator