Denis Katz Medical Affairs

The honest response is to stop designing trials around inert placebos and build more credible control conditions. That means active comparators like low-dose stimulants, niacin, or sub-therapeutic microdoses, combined with centralized raters who are blinded to the patient’s dosing experience and kept structurally separate from the therapeutic team. These designs are harder to execute and more expensive. They’re also what the regulatory bar now requires. Sponsors who haven’t internalized that yet are going to find out the hard way.