Lilly buys AtaiBeckley·$3.8bnOtsuka buys Transcend·$1.2bnAbbVie buys Gilgamesh·$1.2bnatai buys Beckley Psytech·terms undisclosedAbbVie takes an option on Gilgamesh·$2bnLilly buys AtaiBeckley·$3.8bnOtsuka buys Transcend·$1.2bnAbbVie buys Gilgamesh·$1.2bnatai buys Beckley Psytech·terms undisclosedAbbVie takes an option on Gilgamesh·$2bnLilly buys AtaiBeckley·$3.8bnOtsuka buys Transcend·$1.2bnAbbVie buys Gilgamesh·$1.2bnatai buys Beckley Psytech·terms undisclosedAbbVie takes an option on Gilgamesh·$2bn
Next issueIssue 16 · Tue 29 Sep 

Glossary

Open-label

An open-label trial, also written open label, is one in which nobody is blinded: the patient and the investigator both know who is getting the drug.

Why it matters here

Open-label results are the most quoted and, in our opinion, the least informative evidence in this field, and the reason is specific to psychedelics rather than general. These drugs produce effects a patient cannot miss, so expectation is doing work in every arm of every trial, and removing blinding removes the only defence against it. That does not make an open-label study worthless. It makes it an answer to a different question: whether a protocol can be run at all, at what dose, with what side effects. When a company leads with an open-label number and a blinded readout exists, we read the blinded one.

We put it in one line in Issue 12, reporting the only new European registration in five weeks: "Open-label means everyone knows who gets the drug; it answers feasibility, not efficacy."

The clearest demonstration in our own coverage is the contrast we drew in Issue 2 between a real-world Swiss cohort and Germany's blinded EPIsoDE trial: "The open-label route looked convincing; the blinded trial could not separate psilocybin from its placebo. That does not prove expectancy explains the difference, since the two studies differ in more than their blinding, but it puts the burden of proof on the trial that was built to settle the question and didn't." We summarised the pattern in the same issue: within treatment-resistant depression, the looser the design, the larger the effect looked.

The label also turns up as a tail on an otherwise blinded trial. An open-label extension is the period after the controlled phase in which every remaining participant receives the drug, and it is where durability claims are often generated. Issue 10 records both AtaiBeckley Phase 3 trials carrying a 52-week open label extension, and Issue 11 records the same on the BPL-003 Phase 2b in the European register.

In Issue 5 we applied the standard to a result we were otherwise sympathetic to, calling BPL-003's on-SSRI data "real but tiny: a single-center, open-label, 12-patient study, six dosed at 10mg and six at 12mg, no control arm."

Where it appears