The Candesartan Adjunctive Major Depression Trial - CADET: A double-blind, randomised, placebo-controlled trial

The CADET-UD trial dataset is derived from a multi-site, double-blind, randomized, placebo-controlled 16-week study examining the efficacy of candesartan 16 mg/day as an adjunctive treatment for major depressive disorder (MDD). The trial aims to recruit 240 participants aged 18 years and above with moderate to severe MDD. Candesartan, an AT1R agonist, is hypothesized to target key biological factors involved in the pathophysiology of major depressive disorder, including stress reactivity, the HPA axis, oxidative and inflammatory stress, and neurogenesis.

The study employs permutated block randomization to allocate participants to either the active treatment or placebo group in a 1:1 ratio, ensuring blinding across participants, administrators, outcome assessors, and data analysts. The primary outcome measure is the change in depressive symptoms, assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS), with secondary outcomes including additional mental and physical health indicators.