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

Deakin University

Dataset description

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.
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FOR: Mental Health |

Source Study

Trial acronym


Trial ID





Phase 2 / Phase 3


Government body,National Health and Medical Research Council (NHMRC)

Scientific enquiries

Prof Michael Berk

Brief Summary

There is currently a crisis in drug discovery for neuropsychiatric disorders, with a profound, yet unexpected drought in new drug development across the spectrum. Increasing attention to biomarker-indicated targets is likely to be a promising avenue for new drug discovery. Candesartan, an AT1R agonist, may target key biological factors in the pathophysiology of major depressive disorder. Candesartan reduces stress reactivity, impacts the HPA axis, oxidative and inflammatory stress and enhances n ....
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Key Inclusion Criteria

I. A DSM-5 diagnosis of current major depressive disorder determined by the SCID-5-RV II. Moderate to severe depression indexed by a MADRS score of greater than or equal to 20. If there is a delay of greater than 7 days between screening and baseline assessments, or baseline assessment and medication commencement, the inclusion scale (MADRS) should be administered again to ensure the participant still meets eligibility criteria; III. Aged 18 years and above; IV. Have the capacity to consent to t ....
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Key Exclusion Criteria

I. A diagnosis of bipolar disorder and/or another psychotic disorder and/or current substance use disorder, assessed using the SCID-5-RV; II. Undergoing electroconvulsive therapy (ECT) or transcranial magnetic stimulus (TMS) therapy; III. Known or suspected clinically unstable systemic medical disorder, including heart disease especially congestive heart failure, cerebrovascular, liver or kidney disease including renal artery stenosis; IV. Participants on current use of any AT1R blockers or ACE ....
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Can healthy volunteers participate?




Sample Size    240

Min. age    18 Years

Max. age    No limit

Sex    Both males and females

Condition category    Major depressive disorder

Condition code    Mental Health


Intervention code Treatment: Drugs

16 weeks of adjunctive candesartan 16mg oral tablet, once a day. Treatment adherence will be assessed by tablet count of returned trial medication bottles.


Control group Placebo

Matched placebo tablets, 16mg once a day


Outcome: Change in severity of mood symptoms, measured using Montgomery-Åsberg Depression Rating Scale (MADRS)
Timepoint: Conducted at all trial visits - Baseline (week 0) and Weeks 2, 4, 8, 12 and 16 (primary endpoint).

Study Protocol: Study protocol
Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?


What data in particular will be shared?

All de-identified clinical trial data will be available following publication of the primary data and a-priori secondary data.

When will data be available?

Data will be available following publication of primary and a-priori secondary outcomes. No end date.

Available to whom?

Available to research staff with appropriate Human Research and Ethics Approval.

Available for what types of analyses?

All types, both individual-level analyses as well as meta-analyses.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see