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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.

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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. We presented that work at the 2022 Psych Congress Annual Meeting in New Orleans and at the 6th International Conference on Neurology and Brain Disorders in Orlando.

The protocol studied is the one we still use: three infusions over three days, then two further infusions at three to six months.

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What it showed

78 of the 87 patients — 89.4% — completed the full two-phase course.

Counting every patient who started, including the nine who did not finish

• About 79% responded — 69 of 87
• About 51% reached remission — 44 of 87

Counting only the 78 who completed the course

• 88.4% responded
• 56.3% reached remission

The average time between finishing the course and needing a further infusion was 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.

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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.

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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.

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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.

• 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.
• 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.
• 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.

Related pages

The RESTORE Method  ·  Are You a Candidate?  ·  Safety, Risks and Limits  ·  Fees