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Ketamine showdown: which form works best for stubborn depression?

NCT ID NCT06278779

Symptom relief Sponsor: The George Institute 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study compares two forms of ketamine—Spravato (a nasal spray) and standard racemic ketamine (given as an infusion)—in 162 adults with treatment-resistant depression. Participants will be randomly assigned to one treatment and will complete questionnaires about mood, side effects, and quality of life. The goal is to see which option is more effective and better tolerated.

What this could mean

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

Active substance
ketamine (Spravato and racemic ketamine)
What this could lead to
If successful, this trial could show which form of ketamine works better for people with hard-to-treat depression, potentially improving treatment guidelines.
What could go wrong
This is a relatively small study (162 people) and results may not apply to everyone. Ketamine can cause side effects like dissociation and blood pressure changes, and long-term effects are still being studied.

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.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 162 people

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

Started

Jun 2024

Expected to finish

Apr 2027

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.

Ages

18 years and older

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: * Adult with treatment-resistant depression (TRD: not responded adequately to at least two different antidepressants of adequate dose and duration) who has a current depressive episode (DSM 5) * Assessed and attested by clinic psychiatrist as appropriate to receive either racemic ketamine or Spravato® ketamine treatment for TRD * MADRS score of ≥20 at study baseline, assessed by certified study rater * Aged ≥18 years * Written informed consent for research study obtained Exclusion Criteria: * Not able to give informed consent * Any physical or mental condition which, in the opinion of the investigator, could interfere with study participation including outcome assessments * Any treatment with ketamine or Spravato® within 4 weeks prior to written informed consent for the research study * Patients who require an interpreter/translator for the clinic consent process, due to the infeasibility of obtaining an interpreter for research assessments, including self-rated scales

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Conditions

The condition(s) this trial relates to.

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 study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    7 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

  • Black Dog Institute

    RECRUITING

    Randwick, New South Wales, 2031, Australia

    Contact Email: •••••@•••••

  • Gold Coast University Hospital

    RECRUITING

    Southport, Queensland, 4215, Australia

  • Ramsay Clinic Albert Road

    RECRUITING

    Melbourne, Victoria, 3004, Australia

  • Ramsay Clinic Lakeside

    RECRUITING

    Warners Bay, New South Wales, 2282, Australia

  • Ramsay Clinic Northside

    RECRUITING

    St Leonards, New South Wales, 2065, Australia

  • Royal Melbourne Hospital

    RECRUITING

    Parkville, Victoria, 3052, Australia

  • Royal Prince Alfred Hospital

    RECRUITING

    Camperdown, New South Wales, 2050, Australia

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