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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorSenz

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

120 Participants
are grouped into 1 trial group
Group A: adults with treatment resistant depression

Trial outcomes

Primary outcomes

1

Beck Depression Inventory

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

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

Secondary outcomes

1

Montgomery-Åsberg Depression Rating Scale

depression clinician report. Zero is equivalent to no depression and 60 indicates the highest score on depression.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Senz

Lead sponsor

Radboud University Medical Center

Collaborator