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Ketamine plus talk therapy shows promise for stubborn depression

NCT ID NCT07706478

Disease control Sponsor: Senz Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time

Summary

This trial tests a treatment called ketamine-assisted psychotherapy (KAP) for people with treatment-resistant depression. Participants receive intravenous ketamine along with psychological support and integration sessions. The goal is to see if this combination helps improve emotional processing and leads to lasting relief from depression.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ketamine combined with psychotherapy
What this could lead to
If successful, this could offer a new treatment option for people with depression that hasn't responded to standard therapies.
What could go wrong
This is an early-stage, open-label trial with no placebo group, so results may be influenced by expectation. Ketamine can cause side effects like dissociation and blood pressure changes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Jan 2033

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

Depression Depressive Disorder, Treatment-Resistant

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Treatment resistant depression

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • SENZ

    RECRUITING

    Doorn, Utrecht, 3941ZS, Netherlands

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