Our results
Our results, and how to read them
We publish our own outcome data, and we publish its limitations alongside it. Both are part of the same disclosure.
What follows is a description of what happened to our patients. It is not proof of what will happen to you, and the page says so more than once, on purpose.
Poster presentation, 2022
A New Methodological Approach to Improve the Real-World Effectiveness of Ketamine Infusion Therapy for Treatment-Resistant Depression
Presented at the Psych Congress Annual Meeting, New Orleans, September 2022, and at the 6th International Conference on Neurology and Brain Disorders, Orlando, October 2022. The study at a glance:
What the data is
Between 2017 and 2022 we tracked outcomes for 87 patients treated for treatment-resistant depression with the RESTORE protocol at this practice, scored with the Beck Depression Inventory-II.
The protocol studied is the one we still use: three infusions over three days, then two further infusions at three to six months.
Objective. Ketamine is recognized as a rapidly acting antidepressant; however, discrepancies exist between the “Efficacy” reported in research studies (70-85%) versus significantly lower “Effectiveness” (18.3-45.5%) reported in community-based settings. To offset the “Efficacy-Effectiveness” gap a novel, clinically applicable methodology (RESTORE) was developed to improve both effectiveness and durability.
Methods. Patient eligibility was determined by a three-step patient evaluation and suitability protocol. Patients received 3 infusions over 3 days and were dosed with the amount of ketamine, based on pharmacokinetic modeling, to achieve optimal blood concentrations. The medication was administered intravenously via a multimodal, variable rate infusion over 30 minutes. Following induction, patients received two additional infusions within 3-6 months before entering the maintenance phase. Symptom severity was determined utilizing the Beck Depression Index-II (BDI-II).
That is the objective and the method, unedited. The results are set out below, in the section that follows.
The abstract also set our response and remission figures against those reported in community-based studies. We do not repeat that comparison here. Those studies were run by different teams, in different populations, with different selection criteria, and no controlled comparison between them and our series has ever been done. A difference between two uncontrolled numbers is not a measure of how much better one treatment is than another, and we are not going to present it as one.
What it showed
78 of the 87 patients, 89.4%, completed the full two-phase course.
These are technical terms and they do not mean quite what they sound like. Both were measured with the Beck Depression Inventory-II, a validated questionnaire that the patient fills in, not something we score for them.
Responded means the score fell by at least half from where it started. That is the standard definition used throughout depression research. It is a substantial change. It is not the same as being well.
Reached remission means the score fell all the way into the range the scale treats as minimal symptoms — on the Beck Depression Inventory-II, a score of 13 or below. Not simply improved, but down among the scores of people who are not depressed. That is a considerably higher bar than response, which is why the remission figure is always the smaller of the two.
So a person can respond without reaching remission, and many do. Of the people counted in our response figure, about a third did not reach remission: meaningfully better, still carrying symptoms. When you read any response rate anywhere, including ours, that is what you are being told.
About 79% responded — 69 of 87.
About 51% reached remission — 44 of 87.
88.4% responded.
56.3% reached remission.
The average time between finishing the course and needing a further infusion was about eight months, a mean of 245 days.
We give you both sets of numbers deliberately. The higher pair counts only the people who finished; the lower pair counts everyone who started. The lower pair is the more honest guide to what you should expect, and it is the one we would want to be judged on.
What this data is not
This is a retrospective review of one practice — ours. It is not a randomized controlled trial. There was no control group, no blinding, and no independent adjudication of the results.
Patients were selected by us for treatment, which means this group is not comparable to an unselected population. It has been presented at medical meetings, which involves review by a scientific committee but is a considerably lower bar than peer-reviewed publication, and it has not been replicated by anyone else.
None of that makes the data worthless. It does mean you should read it as a description of what happened to our patients, not as proof of what will happen to you.
Why it has not been published in a journal
The protocol involves methods we treat as proprietary, and the journals we approached required a transfer agreement broad enough to compromise that. We chose to present at meetings instead.
That is a commercial decision and it has a cost: our results carry less weight than published, replicated work, and they should.
What the wider evidence shows
Ketamine’s antidepressant effect has been replicated many times since the original Yale work in the late 1990s. What remains genuinely unsettled is how long benefit lasts, how best to maintain it, how well trial results translate into routine practice, and whether blinding in ketamine trials is adequate given how noticeable the drug’s effects are.
Published studies of ketamine in community and hospital settings have reported lower response rates, and shorter durability, than the figures reported in research settings. Those studies are listed below.
They are separate studies in different populations, run by different teams, and we are not presenting them as a head-to-head comparison with our own series. No such comparison has been done. We include them so you can see the range of what has been reported.
1. Wilkinson ST, Katz RB, Toprak M, Webler R, Ostroff RB, Sanacora G. Acute and longer-term outcomes using ketamine as a clinical treatment at the Yale Psychiatric Hospital. J Clin Psychiatry. 2018;79(4):17m11731.
2. Sakurai H, Jain F, Foster S, Pedrelli P, Mischoulon D, Fava M, Cusin C. Long-term outcome in outpatients with depression treated with acute and maintenance intravenous ketamine. J Affect Disord. 2020;276:660–666.
3. McInnes LA, Qian JJ, Gargeya RS, DeBattista C, Heifets BD. A retrospective analysis of ketamine intravenous therapy for depression in real-world care settings. J Affect Disord. 2022;301:486–495.
Talk to us
Questions about what these numbers mean for you?
Tell us what you have already tried and we will talk you through what this data does and does not say about your situation.
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RESTORE — ketamine therapy, done precisely.