The Candesartan Adjunctive Depression Trials-CADET: Study Protocols for Double-Blind, Randomized, Placebo-Controlled Trials for Bipolar Depression and Major Depressive Disorder.
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Ashton Melanie M, Park Chun Hui J, Fernandes Brisa S, Hope Judy, Ng Chee H, Hopwood Malcolm, Khoo Jon-Paul, Malhi Gin S, Gwini Stella May, Amerena John, Suppes Trisha, Chatterton Mary Lou, Williams Lana J, Walker Adam J, Turner Alyna, Carvalho Andre, Nierenberg Andrew, Moriarty Emily, Kessing Lars Vedel, Mohebbi Mohammadreza, Dodd Seetal, Moylan Steven, Tiller John, Schrueder Cas, Matthews Bradley, King Joel, Couper Jeremy, Nanayakkara Kurukula Sarangi, Green Jessica E, Narayanaswamy Janardhanan C, Croce Sarah, Lin Sylvia, Nguyen Elle, Corva Rebecca, Cortissos Paul, Hikmet Selin, Russell Sammy, Kim Jee Hyun, Dean Olivia M, Berk Michael
Аннотация
METHODS: The CADET Trials are 2 parallel 16-week double-blind randomized placebo-controlled trials of adjunctive candesartan (or placebo) for the treatment of bipolar depression (CADET-BD) and major depressive disorder (CADET-UD). Each trial aims to recruit 240 adult participants. The primary outcome is the between-group (ie, intervention vs. placebo) differential change from baseline to week 16 in depression symptoms as measured by the Montgomery Åsberg Depression Rating Scale. Secondary outcomes measure depression, mania, anxiety, quality of life, cost-effectiveness, functioning, substance use, cognition, and biological markers.
FINDINGS: Findings are not yet available as the trial is ongoing.
IMPLICATIONS: The CADET Trials examine the efficacy of candesartan in reducing depressive symptoms in both unipolar and bipolar depression, and whether its effects are mediated through the renin-angiotensin system. Candesartan is affordable, accessible, and well-tolerated. If effective, it could quickly be adopted into clinical practice as a new adjunctive medication for the treatment of these disorders.