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Trial registered on ANZCTR


Registration number
ACTRN12609000256279
Ethics application status
Approved
Date submitted
18/12/2008
Date registered
13/05/2009
Date last updated
29/06/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomized trial of homocysteine lowering treatment of depression in later life (B-VITAge)
Scientific title
Randomized trial of citalopram plus vitamins B12, B6 and folate versus citalopram plus placebo for the treatment of depressive episodes amongst adults aged 50 years or over
Secondary ID [1] 259763 0
B-VITAge50
Universal Trial Number (UTN)
Trial acronym
B-VITage
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depressive disorder 3868 0
Condition category
Condition code
Mental Health 4064 4064 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).
Intervention code [1] 4536 0
Treatment: Drugs
Comparator / control treatment
Daily citalopram (20-40 mg) + placebo. , taken orally. The dosage of citalopram will be determined as described (Description of intervention). The placebo tablets have the same shape, size, color, texture and taste as the active vitamin tablets. Treatment with citalopram and placebo tablets will continue for 12 weeks, after which the anti-depressive management of the patient will be transferred back to the general practitioner. Blinded treatment with placebo tablets will continue for a further 40 weeks (52 weeks total).
Control group
Placebo

Outcomes
Primary outcome [1] 4961 0
50% reduction in the scores of the Montgomery-Asberg Depression Rating Scale (MADRS)
Timepoint [1] 4961 0
12, 26 and 52 weeks after introduction of the intervention.
Primary outcome [2] 4962 0
Remission of symptoms (no longer meeting criteria for depressive episode)
Timepoint [2] 4962 0
12, 26 and 50 weeks after introduction of the intervention.
Secondary outcome [1] 8375 0
Change of antidepressant medication (monitored by questionnaire and review of notes 26 and 52 weeks after the introduction of the intervention.
Timepoint [1] 8375 0
26 and 52 weeks after the introduction of the intervention.
Secondary outcome [2] 8376 0
Compliance with treatment monitored by a medication diary (including antidepressant medication and vitamin or placebo tablets), pill counting by the Royal Perth Hospital Pharmacy, and monitoring of the serum concentrations of vitamin B12 and folate.
Timepoint [2] 8376 0
12, 26 and 52 weeks after the introduction of the intervention.
Secondary outcome [3] 8377 0
Adverse events monitored with a checklist of adverse experiences rated as 'not at all', 'a little', 'quite a bit', ''extremely':
1. Tremor of the hands
2. Muscle stiffness
3. Involuntary muscle contractions
4. Muscle Cramps
5. Pins and needles in the body
6. Difficulty concentrating
7. Agitation, feeling restless
8. Feeling unhappy or depressed
9. Irritability
10. Feeling dizzy or faint
11. Headache
12. Other pain
13. Arthritis or pain in the joints
14. Nausea
15. Diarrhoea
16. Constipation
17. Vomiting
18. Anorexia (loss of appetite)
19. Weight loss
20. Weight gain
21. Skin rash
22. Nightmares
23. Excessive somnolence
24. Poor sleep
25. Palpitations
26. Dry mouth
27. Other (any other events not listed above reported by participants in response to the question: 'Have you been bothered by any other physical or emotional symptom during the past 4 weeks?)
Timepoint [3] 8377 0
4, 8, 12, 26 and 52 weeks from baseline (after introduction of intervention)
Secondary outcome [4] 8378 0
Change in cognitive scores (Mini-Metal State Examination and cognitive subscale of the Consortium to Establish a Registry for Alzheimer's Disease - CERAD)
Timepoint [4] 8378 0
12, 26 and 52 weeks from baseline

Eligibility
Key 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.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
- Eligible participants will be recruited from all available sources (local general practitioners and metropolitan mental health services)
- vitamin and placebo capsules have the same shape, size, color, smell, weight and texture. Participants and research staff will be blind to group allocation until the collection of the final endpoint for all participants.
- Randomization and distribution of the study medication will be done centrally by an independent off-site department of the Royal Perth Hospital (Pharmacy)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2009
Actual
31/03/2009
Date of last participant enrolment
Anticipated
Actual
4/09/2012
Date of last data collection
Anticipated
Actual
4/09/2013
Sample size
Target
155
Accrual to date
Final
155
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 4050 0
Government body
Name [1] 4050 0
National Health and Medical Research Council (NHMRC)
Country [1] 4050 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
35 Stirling Highway
Crawley, WA 6009
Country
Australia
Secondary sponsor category [1] 3645 0
Hospital
Name [1] 3645 0
Royal Perth Hospital
Address [1] 3645 0
48 Murray St
Perth, WA 6000
Country [1] 3645 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6128 0
Royal Perth Hospital Ethics Committee
Ethics committee address [1] 6128 0
Ethics committee country [1] 6128 0
Australia
Date submitted for ethics approval [1] 6128 0
Approval date [1] 6128 0
05/12/2008
Ethics approval number [1] 6128 0
EC 2008/197

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29067 0
Prof Osvaldo P. Almeida
Address 29067 0
WA Centre for Health & Ageing (M573)
University of Western Australia
35 Stirlingh Highway
Crawley, WA 6009
Country 29067 0
Australia
Phone 29067 0
+61 8 9224 2855
Fax 29067 0
Email 29067 0
osvaldo.almeida@uwa.edu.au
Contact person for public queries
Name 12224 0
Osvaldo Almeida
Address 12224 0
Western Australia Centre for Health & Ageing (M573)
University of Western Australia
35 Stirling Highway
Crawley, WA 6009
Country 12224 0
Australia
Phone 12224 0
+61 8 92242855
Fax 12224 0
Email 12224 0
osvaldo.almeida@uwa.edu.au
Contact person for scientific queries
Name 3152 0
Osvaldo Almeida
Address 3152 0
WA Centre for Health & Ageing (M573)
University of Western Australia
35 Stirling Highway
Crawley, WA 6009
Country 3152 0
Australia
Phone 3152 0
+61 8 92242855
Fax 3152 0
Email 3152 0
osvaldo.almeida@uwa.edu.au

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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