Randomized trial of homocysteine lowering treatment of depression in later life (B-VITAge)

Phase 3

Completed

• Conditions: Depressive disorder; Mental Health - Depression

• Registration Number: ACTRN12609000256279
• Lead Sponsor: niversity of Western Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 155

Inclusion Criteria

age 50 years or over, of either sex - meet Diagnostic and Statistical Manual of Mental Disorders (4th edition) criteria for the diagnosis of major depressive episode within the context of a depressive disorder - Montgomery-Asberg Depression Rating Scale (MADRS) score of 20 or more - fluent in written and spoken English.

Exclusion Criteria

- evidence of concurrent alcohol or substance abuse or dependency (Alcohol Use Disorders Identification Test – AUDIT = 7),
- clinical evidence of Parkinson’s disease (including treatment),
- prior clinical history of strokes,
- evidence of clinically significant cognitive impairment (i.e., Mini-Mental State Examination – MMSE score < 24),
- evidence of medical morbidity (such as cancer) that may compromise 12-month survival or availability for study assessments,
- currently receiving antidepressant treatment (antidepressant medication or electroconvulsive therapy),
- use of B-vitamins daily for more than 3 months, or receive regular B12 injections
- prior allergic reaction to citalopram or escitalopram,
- use of a monoamine oxidase inhibitor during the preceding 2 weeks,
- no active general practitioner,
- suicide plans,
- no written informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified