Data

Youth Depression Alleviation: Augmentation with Anti-inflammatory Agent (YoDA-A)

Orygen

Dataset description

This 12-week triple blind randomised controlled trial includes young people (15-25 years, 60% female) with moderate to severe major depressive disorder measured using the MADRS, recruited between 2013 and 2017 across Victoria, Australia. All participants received treatment as usual plus either aspirin (n = 40), rosuvastatin (n = 48) or placebo (n = 42) with assessments at baseline and weeks 4, 8, 12 and 26. Dataset includes primary outcome changes in the MADRS scale from baseline to 12 weeks, demographic information, suicidality, anxiety, substance use, and medication.
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Related Study

Youth Depression Alleviation: Augmentation with Anti-inflammatory Agent (YoDA-A)

Brief Summary

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 specialised early intervention centres with moderate to severe major depression if: 1. 12 weeks treatment with either 10 mg rosuvastatin or 100 mg aspirin treatment reduces severity of depression compared to individuals taking treatment as usual: Primary aim. 2. 12 weeks with either 10 mg rosuvastatin or 100 mg aspirin treatment will improve self-reported symptom burden, quality of life, overall functioning and clinical impression and reduce symptoms of anxiety. 3. There are continued benefits following cessation of trial treatment assessed at 6 months following baseline. 4. whether 12-weeks treatment with 10 mg rosuvastatin or 100 mg aspirin reduces serum markers of inflammation, and 5. whether the reduction in inflammatory and oxidative markers correlates with change in depressive symptomatology Primary Hypothesis 1. 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. Predictors of outcome The study will also aim to explore predictors and moderators of treatment response. Predictors are variables present before treatment that influence a person's response to treatment, regardless of the type of treatment received; whereas moderators differentially predict response to the different treatments. We will explore questions such as whether young people with comorbid substance abuse and borderline personality disorder traits are less likely to respond to treatment overall and less likely to respond to one treatment compared to the other. We will also examine whether baseline cognitive factors predict response to the trial medication.

Conditions

Condition Codes

Intervention Code

Inclusion Criteria

  • - 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 psychosocial) needs to be stable treatment for at least two weeks prior to enrolment

Study Type

  • Interventional

Ethics Approval

Study Protocol: Available
Data Dictionary: Not Available

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

yes

What data in particular will be shared?

All of the individual trial-related participant data collected during the trial, after de-identification.

When will data be available?

Data will be available immediately and for an indefinite time.

Available to whom?

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).

Available for what types of analyses?

To any type of analyses. Assessed on a case-by-case basis.