"Once you have an unblinded trial, you potentially have all kinds of questions about efficacy," says David Rind, chief medical officer of the Boston-based nonprofit Institute for Clinical and Economic Review, which published a report in May raising concerns about the validity of the Lykos trial data.
Rind says there are other ways to ensure reliable results. For instance, instead of giving participants in the control arm an inert placebo, Lykos could administer a safe but active drug that is known to produce some physiological effects. This would at least leave patients in doubt about what they received.
The company says its treatment manual allows for a "personalized experience," but FDA advisers had concerns about the variability of psychotherapy offered in the trials.
Because Lykos was testing its own psychotherapy protocol in both the drug and placebo groups, rather than an established trauma-focused therapy, it's hard to know how effective the therapy component was.
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