The Candesartan Adjunctive Bipolar Depression Trial - CADET: A double-blind, randomised, placebo-controlled trial to evaluate the effect of Candesartan on mood in patients with bipolar depression

The CADET-BD trial dataset is derived from a multi-site, double-blind, randomized, placebo-controlled 16-week study designed to evaluate the efficacy of candesartan 16 mg/day as an adjunctive treatment for bipolar depression. This study addresses the significant unmet need for effective depression treatments in bipolar disorder, as current therapies are more effective for managing mania than depression. Candesartan, an AT1R antagonist, is hypothesized to target key biological factors implicated in the pathophysiology of bipolar disorder, such as stress reactivity, the HPA axis, oxidative and inflammatory stress, and neurogenesis.

The study aims to recruit 240 participants aged 18 years and above with moderate to severe bipolar depressive disorder. Participants will be randomly assigned to either the active treatment group (candesartan) or the placebo group, in addition to their usual treatment regimen. 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.