CADET-BD
ACTRN12620000703909
Government body, Medical Research Future Fund (MRFF) National Health and Medical Research Council (NHMRC)
Prof Michael Berk
Depression is the single major unmet need in bipolar disorder and current therapies are more efficacious in mania than depression. Key biological factors in the pathophysiology of bipolar disorder may be targeted by the AT1R antagonist, candesartan. Candesartan reduces stress reactivity, impacts the HPA axis, oxidative and inflammatory stress and enhances neurogenesis; all documented pathological markers. The CADET-BD study will test the efficacy of candesartan 16 mg/day as an adjunctive treatme .... Read more
I. A DSM-5 diagnosis of bipolar disorder I or II, determined using the SCID-5-RV; II. Currently experiencing a major depressive episode, determined using the SCID-5-RV III. Moderate to severe depression indexed by a MADRS score of greater than or equal to 20. If there is a delay of >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 criter .... Read more
I. A diagnosis of 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 within one month of randomisation in the study; 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 an .... Read more
No
Sample Size 240
Min. age 18 Years
Max. age No limit
Sex Both males and females
Condition category Bipolar depression
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).
yes
All de-identified clinical trial data will be available following publication of the primary data and a-priori secondary data.
Data will be available following publication of primary and a-priori secondary outcomes. No end date.
Available to research staff with appropriate Human Research and Ethics Approval.
All types, both individual-level analyses as well as meta-analyses.
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