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.

CADET-BD试验数据集源自一项多中心、双盲、随机、安慰剂对照的16周研究，该研究旨在评估坎地沙坦16mg/日作为双相抑郁辅助治疗的疗效。当前双相障碍抑郁发作的有效治疗方案存在显著未被满足的临床需求，现有治疗手段对躁狂症状的控制效果优于抑郁发作，本研究正是针对这一痛点展开。坎地沙坦作为AT1受体拮抗剂（AT1R antagonist），被推测可靶向双相障碍病理生理学机制中的关键生物学因素，包括应激反应、下丘脑-垂体-肾上腺轴（HPA轴）、氧化与炎症应激，以及神经发生。本研究计划招募240名年龄≥18岁的中重度双相抑郁障碍受试者，受试者在维持常规治疗方案的基础上，将被随机分配至坎地沙坦活性治疗组或安慰剂组。本研究的主要结局指标为采用蒙哥马利-阿斯伯格抑郁评定量表（MADRS）评估的抑郁症状变化；次要结局则包含多项精神与身体健康相关指标。