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Examining the Impact of Sirolimus on Ketamine’s Antidepressant Effects

CompletedRegisteredCTG

Randomised, triple-blind, placebo-controlled crossover trial (n=23) testing whether a single 6 mg oral dose of sirolimus alters the antidepressant response to two ketamine infusions (0.5 mg/kg IV over ~40 minutes) in participants with antidepressant-resistant depressive symptoms.

Details

This double-blind, randomized crossover study (n=23) evaluates whether sirolimus (6 mg oral) modifies the acute and short-term antidepressant effects of ketamine (0.5 mg/kg IV infused over ~40 minutes), with each participant receiving two ketamine infusions separated by two weeks.

Primary population includes adults 21–65 with antidepressant-resistant major depressive episodes; outcomes include MADRS change and safety/tolerability, with sirolimus/placebo administered ~2 hours prior to infusions.

Topics:Treatment-Resistant Depression (TRD)

Registry

Registry linkNCT02487485