YODA-A
ACTRN12613000112763
Treatment
Phase 3
Government body,NHMRC: National Health and Medical Research Council
Prof Prof. Michael Berk, Professor of Psychiatry
This study is 12-week acute treatment trial for moderate to severe major depressive disorder (MDD). It is designed to establish whether the use of (i) rosuvastatin or (ii) aspirin, reduces symptom severity and prevents recurrence of depression in young people. In this 3-arm controlled design, add-on therapy to treatment as usual (TAU) with rosuvastatin or aspirin will be compared to placebo. Aims Using a randomised placebo controlled trial, we aim to assess in individuals presenting to specialis .... Read more
- aged of 15 to 25 years inclusive - have a diagnosis of current Major Depressive Disorder (MDD) using Structured Clinical Interview for DSM-IV Axis I Disorders (SCID) - a score on the Montgomery-Asberg Depression Rating Scale of >/=20 - ability to give informed consent and comply with study procedures - female participants are required to use effective contraception if sexually active - established fluency in English - if currently on treatment, that treatment (either pharmacological or psychos .... Read more
- First episode psychosis (at least one positive symptom occurring daily for at least one week, or at least three times per week if the symptom lasts for longer than one hour on each occasion) - SCID-I/P diagnosis of diagnosis of bipolar I or II disorder or alcohol dependence - acute or unstable systemic medical disorder (determined by the treating physician including the review of the routine bloods assessment), including abnormal liver function, thyroid function or haematological findings; or .... Read more
No
Sample Size 130
Min. age 15 Years
Max. age 25 Years
Sex Both males and females
Condition category Depression
Condition code Mental Health
Intervention code Treatment: Drugs
Arm 1: 10 mg/day rosuvastatin by oral capsule for 12 weeks Arm 2: 100 mg/day aspirin by oral capsule for 12 weeks Arm 3: Placebo by oral capsule for 12 weeks
Control group Placebo
Placebo capsules (starch) matched in appearance and taste will be used.
Outcome: 12-weeks of adjunctive rosuvastatin or aspirin treatment will be superior to placebo for reducing symptoms of depression using the Montgomery-Asberg Depression Rating Scale (MADRS). Analysis of rosuvastatin compared with placebo will be conducted separately to aspirin compared with placebo. Changes in MADRS scores in each medication individually are the primary outcomes.Timepoint: At 12 weeks after randomisation
Outcome: 12 weeks of adjunctive rosuvastatin or aspirin treatment will be superior to placebo from the participant's perspective, based on the Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR).Timepoint: At 12 weeks after randomisation
yes
All of the individual trial-related participant data collected during the trial, after de-identification.
Data will be available immediately and for an indefinite time.
Data will potentially be available to researchers from not-for profit organisations, commercial organisations or other based in any location. All data requests will be considered by the data custodian and the primary sponsor on a case-by-case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted. For further information, see Orygen data sharing policy (upon request).
To any type of analyses. Assessed on a case-by-case basis.