No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
162 (estimated)
Sponsor
The George Institute · Other
Who this trial is looking for
This trial is looking for adults with treatment-resistant depression who have not found relief from at least two antidepressants. Participants will be randomly assigned to receive either Spravato® or racemic ketamine and will complete questionnaires about their mood, side effects, and quality of life.
Are You a Good Fit for This Trial?
You may be able to join if
I have treatment-resistant depression.
I have a current depressive episode.
I have a MADRS score of 20 or higher.
I am at least 18 years old.
I can provide written consent for the study.
You may not be able to join if
I cannot give informed consent.
I have a condition that interferes with the study.
I have taken ketamine or Spravato® in the last 4 weeks.
I require an interpreter for the consent process.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The goal of this study is to compare the effectiveness of two formulations of ketamine - Spravato® and racemic ketamine - in people with treatment-resistant depression (TRD). The main questions it aims to answer are:
* How the two formulations compare in terms of their effectiveness in treating TRD.
* How the two formulations compare in their acceptability to patients, safety, effects on patient …
The goal of this study is to compare the effectiveness of two formulations of ketamine - Spravato® and racemic ketamine - in people with treatment-resistant depression (TRD). The main questions it aims to answer are:
* How the two formulations compare in terms of their effectiveness in treating TRD.
* How the two formulations compare in their acceptability to patients, safety, effects on patient quality of life and function, and cost effectiveness.
Participants will be randomised to receive either Spravato® or racemic ketamine treatment and asked to complete some questionnaires to assess the effects on mood, treatment acceptability, side effects, quality of life and function, and health economic outcomes.
Trial Locations
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Eligibility Criteria
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 racemi…
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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