Treatment Resistant DepressionNCT07706478
Working Mechanisms and Effectiveness of IV Ketamine-assisted Psychotherapy on Depression in TRD Clients
An observational study of Treatment Resistant Depression, run by Senz at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Treatment Resistant Depression
- How many people
- 120 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2025to Jan 2033
- How long will I take part?
- 12 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clients of Senz with TRD who are eligible for IV ketamine treatment (KAP)
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
SENZ
Doorn, Utrecht, 3941ZS
Rutger Engels, dr, +31 343 235300, r.engels@senzggz.nl
karlijn kindt, dr, +31 343 235300, k.kindt@senzggz.nl
About this study
Official title: Effectiveness and Underlying Mechanisms of an Innovative Treatment Program for Persistent Mood and Anxiety Conditions
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.
Read the detailed description
Ketamine-Assisted Psychotherapy (KAP) combines the administration of intravenous ketamine with psychotherapy in a structured and medically supervised treatment programme. At Senz, KAP is currently being offered within the context of an open-label clinical trial for adults with persistent or treatment-resistant depression who have not experienced sufficient benefit from previous pharmacological and psychological treatments. The aim of the study is to evaluate both the clinical effectiveness and the subjective therapeutic impact of KAP in routine mental healthcare.
The treatment consists of several phases, including comprehensive psychological and psychiatric assessment, medical screening, preparation sessions, ketamine administration sessions, and post-session integration therapy. Prior to participation, clients undergo a detailed evaluation of psychiatric history, previous treatments, physical health, medication use, and relevant laboratory tests. During preparation sessions, participants receive psychoeducation, explore treatment intentions, learn techniques for emotional regulation, and develop a therapeutic framework for working with the experiences that may arise during ketamine sessions.
Safety is a central component of the protocol. Ketamine is administered intravenously in a controlled clinical environment under the supervision of a psychiatrist, psychologist, and trained nursing staff. Vital signs, including blood pressure, heart rate, and oxygen saturation, are monitored throughout treatment. Participants are screened for medical and psychiatric contraindications, and clear procedures are in place for managing adverse events or unexpected reactions. Following each treatment session, participants remain under observation until clinically stable and are required to arrange supported transport home.
The study includes a comprehensive assessment programme to evaluate both outcomes and therapeutic processes. Standardised measures of depressive symptoms are collected throughout treatment, alongside questionnaires assessing subjective experiences. Integration sessions following each ketamine administration help participants reflect on their experiences, consolidate insights, and translate these into meaningful behavioural changes in daily life. By combining rigorous clinical monitoring with psychotherapy and systematic outcome assessment, the trial aims to contribute to the growing evidence base for ketamine-assisted psychotherapy while providing high-quality care for participants.
- Conditions
- Treatment Resistant Depression
- Keywords
- KAP, TRD, Depression, IV ketamine
- Medical subject headings
- Depressive Disorder, Treatment-Resistant, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory
depression self-report measure. Zero is equivalent to no depression and 64 indicates the highest score on depression.
Measured: 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.
Measured: baseline/pre-intervention/post-intervention (end of treatment)/3months after post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start1 Jun 2025
- Primary completionJan 2033 (estimated)
- Study completionJan 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Senz
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center
- Responsible party
- Principal investigator, Rutger Engels, Senz
- Investigators
- Rutger Engels, Principal investigator, Senz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706478
- Sponsor's protocol ID
- 24-343/DB/02
- Status last verified
- Jul 2026
- First submitted
- 3 Jun 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: not decided yet, will be discussed in the team