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

Phase 3

Completed

• Conditions: Depression; Mental Health - Depression

• Registration Number: ACTRN12613000112763
• Lead Sponsor: Orygen, the National Centre of Excellence in Youth Mental Health, The University of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-30
• Study Completion: 2017-08-08
• Last Update Posted: 6 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 130

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

Exclusion Criteria

- 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 acute or unstable systemic medical disorder, including immune disorders, bleeding disorders (such as haemophillia), significant gastric pathology (e.g. gastric haemorrhage, erosive gastritis or active peptic ulcer disease) and pre-existing cardiac disease
- inability to comply with the requirements of informed consent or the study protocol (such as incapacity to consent, determined by the treating physician and research team)
- current regular (>weekly) use of statins, aspirin, NSAID’s paracetamol, corticosteroids or any other immunomodulatory agents
- Currently taking hypolipidaemics (e.g. gemfibrozil, nicotinic acid; cyclosporine), vitamin K antagonists and other anticoagulants (e.g. warfarin), protease inhibitors (including ritonavir), antacids (within 2 hrs); ketoconazole; spirinolactone; or cimetidine
- participants with a history of intolerance or allergy to study medications and those who are currently pregnant or breast feeding will also be excluded

Study & Design

• Study Type: Interventional
• Study Design: Not specified