None listed
Conditions
Brief summary
Older people with depression have higher plasma concentration of a chemical called homocysteine than non-depressed older adults. The use of some vitamins of the B group are effective in reducing the plasma concentration of homocysteine. We designed this trial to determine if the use of adjunctive treatment with B-vitamins improves the efficacy of antidepressant treatment for people aged 60 years or over.
Interventions
Daily citalopram (20-40 mg) + 0.5 mg B12, 25 mg B6 and 2 mg folic acid (as a single tablet), both taken orally. Citalopram will be introduced at a dosage of 10mg per day and increased to 20mg per day after 2 weeks. After 4 weeks of treatment the dosage of citalopram will be increased to 30mg for those who still meet the Diagnostic & Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for a depressive episode, and again to 40mg at week 8, if a major depressive episode is still p
Daily citalopram (20-40 mg) + 0.5 mg B12, 25 mg B6 and 2 mg folic acid (as a single tablet), both taken orally. Citalopram will be introduced at a dosage of 10mg per day and increased to 20mg per day after 2 weeks. After 4 weeks of treatment the dosage of citalopram will be increased to 30mg for those who still meet the Diagnostic & Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for a depressive episode, and again to 40mg at week 8, if a major depressive episode is still present and no significant adverse events are reported. Treatment with citalopram and vitamins will continue for 12 weeks, after which the anti-depressive management of the patient will be maintained by the general practitioner (who will be free to increase/decrease the dosage of antidepressant or to change the medication). Blinded treatment with vitamins will continue for a further 40 weeks (52 weeks total).
Sponsors
University of Western Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed