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
- Are there results?
- Not yet: the study is under way
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)
Show all 11Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Underlying Mechanisms of an Innovative Treatment Program for Persistent Mood and Anxiety Conditions
- ClinicalTrials.gov ID
- NCT07706478
- Acronym / sponsor ID
- 24-343/DB/02
- Conditions
- Treatment Resistant Depression
- Keywords
- KAP, TRD, Depression, IV ketamine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- SenzUniversity, hospital or other
- Collaborators
- Radboud University Medical Center
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- Jan 2033 (estimated)
- Study completion
- Jan 2033 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clients of Senz with TRD who are eligible for IV ketamine treatment (KAP)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Beck Depression Inventory
Time frame: baseline/pre-intervention/post-intervention (end of treatment)/3months after post-intervention
depression self-report measure. Zero is equivalent to no depression and 64 indicates the highest score on depression.
1 secondary outcome
Montgomery-Åsberg Depression Rating Scale
Time frame: baseline/pre-intervention/post-intervention (end of treatment)/3months after post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- website clinicLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. not decided yet, will be discussed in the team
Related trials for Treatment Resistant Depression
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
RecruitingPhase 2
ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response
Major Depressive Disorder (MDD), Depressive Disorder, Treatment-Resistant
Active, not recruiting
CET- REM (Correlating ECT Response to EEG Markers)
ECT, Treatment Resistant Depression
Active, not recruiting
rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
Depression, Treatment Resistant
Recruiting
A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression
Treatment Resistant Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rutger Engels principal investigator
Senz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Treatment Resistant Depression, run by Senz at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rutger Engels, dr (+31 343 235300, r.engels@senzggz.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Depression Inventory (time frame: baseline/pre-intervention/post-intervention (end of treatment)/3months after post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.