Dr Seren Haf Roberts Institute of Medical and Social Care Research, Bangor University Health and Wellbeing Public Lecture Series Two Venue Cymru ...
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Dr Seren Haf Roberts
Institute of Medical and Social Care Research,
Bangor University
Health and Wellbeing Public Lecture Series Two
Venue Cymru Llandudno, 18th Oct 2011
Dr Seren Haf Roberts
Institute of Medical and Social Care Research,
Bangor University
Health and Wellbeing Public Lecture Series Two
Venue Cymru Llandudno, 18th Oct 2011
http://www.simpsoncrazy.com/pictures/homer
As consumers of medicines we may want to know e.g. .... Why we take them How much to take How long to take them for What the side effect are Will it react to other medicines Will it make us feel better How they work What are the alternative treatments
Clinicians/prescribers may want to know more e.g. Which patients are more likely to respond better to treatments Which patients are more likely to get side effects Which medicines are better than others Are there ways to improve the way these medicines work
CLINICAL RESEARCH!!
http://www.icr-global.org
Not
as much as we
would like!
The Wall Street Journal, November 1, 1983
By 2020, major depression is predicted to be the second leading cause of disability worldwide (World Health Organization; Murray & Lopez, 1997) Up to 1 in 4 will develop depression as some point in their lives More than 150 million people suffer from depression at any point in time 11% of people in England were diagnosed with depression in 2009-10, along with 11.5% of people in Northern Ireland, 8.6% in Scotland and 7.9% in Wales (Social Trends 41, Office of National Statistics)
In one UK Study, the direct treatment costs for depression were estimated at £370 million, of which 84% was attributable to antidepressant medication Indirect costs were higher with a total morbidity costs (loss of earnings) at £8 billion and mortality costs at £562 million (Thomas & Morris, 2003)
THE STEPPED-CARE MODEL
Focus of the intervention Nature of the intervention
STEP 4: Severe and Medication, high-intensity
complexa depression; risk psychological interventions,
to life; severe self-neglect electroconvulsive therapy,
crisis service, combined
treatments, multiprofessional
and inpatient care
STEP 3: Persistent subthreshold Medication, high-intensity
depressive symptoms or mild to psychological interventions,
moderate depression with combined treatments, collaborative
inadequate response to initial careb and referral for further
interventions; moderate and assessment and interventions
severe depression
STEP 2: Persistent subthreshold Low-intensity psychosocial interventions,
depressive symptoms; mild to psychological interventions, medication
moderate depression and referral for further assessment and
interventions
STEP 1: All known and suspected Assessment, support, psychoeducation,
presentations of depression active monitoring and referral for further
assessment and interventions
aComplex depression includes depression that shows an inadequate response to multiple treatments, is complicated by psychotic symptoms, and/or is associated with
significant psychiatric comorbidity or psychosocial factors.
bOnly for depression where the person also has a chronic physical health problem and associated functional impairment (see ‘Depression in adults with a chronic physical
health problem: treatment and management’ [NICE clinical guideline 91]).
NICE (2010) Clinical Practise Guideline 90 The number of people taking antidepressants has risen over last 20 years In 2009, a total of 39.1 million antidepressant prescriptions were issued in England compared with 9 million in 1991 (334% increase) Antidepressant prescriptions have also risen by 88% in Wales between 2000 and 2009(Social Trends 41, Office of National Statistics) However only 50% of sufferers respond well to antidepressant treatment, while one-third respond to placebo (Agency for Health Care Policy and Research).
To summarise…
Depression is a major problem
Its costly to the individual, the NHS and society
Antidepressants are a key treatment for
moderate to severe depression
We don’t know as much as we should so we need
to know more about depression and its
treatments
To prevent or reduce likelihood of developing
depression
To help people overcome depression as quickly as
possible
To maintain wellbeing after depression
So how much research goes on?Proportion of Participating Charities’ Spend in All
Health Categories
0.00% 5.00% 10.00% 15.00% 20.00% 25.00% 30.00%
Other 0.00%
Ear 0.00%
Skin 0.20%
Blood 0.20%
Injuries 0.20%
Congenital 0.30%
Mental Health 0.50%
Eye 0.50%
Oral and Gastrointestinal 0.80%
Cardiovascular 1.10%
Reproductive health 1.60%
Infection 3.00%
Renal and Urogenital 3.00%
Stroke 3.00%
Respiratory 3.60%
Generic 6.30%
Metabolic and Endocrine 6.70%
Neurological 13.40%
Musculoskeletal 15.20%
Inflammatory and Immune 15.30%
Cancer 25.10%
From UKCRC& AMRC (2007) From Donation to Innovation. (www.ukcrc.org)Proportion of Combined Spend on Health Specific
Categories
0.00% 5.00% 10.00% 15.00% 20.00% 25.00% 30.00%
Other
Injuries
Skin
Congenital
Blood
Eye
Renal and Urogenital
Stroke
Respiratory
Ear
Oral and Gastrointestinal
Musculoskeletal
Reproductive health
Metabolic and Endocrine
Mental Health
Generic
Inflammatory and Immune
Cardiovascular
Infection
Neurological
Cancer
From UKCRC (2006) Health Research Analysis (www.ukcrc.org)Includes.... Depression Schizophrenia Psychosis and personality disorders Addiction Suicide Anxiety Eating disorders Learning disabilities Autistic spectrum disorders Studies of normal psychology, cognitive function and behaviour
Around 99 studies related to depression on the UK Clinical Research Collaboration portfolio (28 open to recruitment; 6 in set up; and 65 closed) Around 17 studies related to antidepressants (4 open to recruitment, and 13 closed to recruitments)
Mental Health Research Network Cymru…
Current portfolio 48 studies (30 active; 15
completed & 3 commercial studies and a total
funding value of £13,858,370)
Of which 11 studies relate in some way to
depression (funding value £3,985,523) and 1 to
antidepressant research (funding value
£900,000*)
* Following a study extension, funding amounted
to £1.5 million Growing interest in link between B vitamins and depression In adults and older adults, studies have shown a strong association between folate deficiency and depression symptoms symptom severity treatment outcomes Emergingevidence also suggesting a possible link between B6 and B12 and depression
Strong evidence for the role of folate in other disease areas, such as neural tube defects This has led to large-scale public health interventions such as the enrichment of foods (e.g. cereal and flour) Many countries have done this including USA and Canada Still in debate in UK as evidence not clear cut Not entirely harmless, are we exposing public to other potential health risks?
We don’t yet fully understand the role of dietary intake of these vitamins in depression what the long term effects of folate supplementation on health are (including mental health) whether the role of these B vitamins in depression differ between dietary forms and synthetic forms whether pre-treatment folate and B12 levels predict response to antidepressants whether folate supplementation could improve response to antidepressants There is also uncertainty about classification of deficiencies of these vitamins how best to measure them
Folate status in patients with depression
1/3 of patients with depression have decreased folate levels
People with low folate respond less well to antidepressants
Folate & antidepressant response
Antidepressants work via effects on synaptic neurotransmitter
activity
Folate is a methyl-donor in many methylation reactions in the
brain involving these neurotransmitters
This evidence tells us that folic acid:
1. May be a useful supplement to antidepressants
2. Should be considered in the treatment of depressionPRIMARY RESEARCH QUESTION
Is supplementing antidepressants with folic acid clinically-
and cost-effective in the treatment of moderate to severe
depression?
SECONDARY RESEARCH QUESTIONS
Does response to antidepressants depends on genetic
factors?
Does baseline folate status predict treatment response?
Does enhancing folate status decrease homocysteine levels
and increase MethylMalonic Acid levels?and is supported by …
• NHS funded through the National Screening Interview (Visit 1 week -2)
Institute of Health Research Health
Technology Assessment Programme -
£1.5 million Randomisation appointment (Visit 2 week 0)
•Large, multi-centred, double-blind, Blood results
Randomisation (Folic acid/placebo)
placebo-controlled trial Repeat assessments
•Target - 730 recruited from primary
and secondary care from 3 centres in
Wales; North East Wales (Wrexham), First follow up (Visit 3 week 4)
North West Wales (Bangor) and
Swansea
•Target - 453 allocated by chance Second follow up (Visit 4 week 12)
(randomised) to 5mg folic acid or
matching placebo
•Followed up 4wks, 12wks & 6mths Third follow up (Visit 5 month 6)Referred n=1489
Excluded n=629
Screened n=860
Excluded n=224
Recruited n=634
Lost to Trial n=159
Randomised n=475800
698
700
600
500
401 390 Referred
400
Recruited
306
300 Randomised
238
200 163 165
119 118
100
0
Bangor Wrexham Swansea Currentlyin analysis phase so unable to
give any results
Results
should be out next summer …
please watch this space!!http://www.icr-global.org
We can do it in Wales! Wales can contribute significantly to the international evidence base for the treatment of depression through conducting quality research We have shown that we have capacity and capability North Wales has a real strength for depression and antidepressant trials Is ignorance bliss? Not when it comes to depression!
"When I was fourteen, my father was so
ignorant I could hardly stand to have him
around. When I got to be twenty-one, I was
astonished at how much he had learned in
seven years."
Mark TwainMurray CJL, Lopez AD. Global mortality, disability and the contribution of risk factors. Global Burden of
Disease Study. Lancet. 1997;349:1436.
World Health Organisation (2003) Investing in Mental Health, Geneva, Switzerland: World Health
Organization.
Thomas, C. M. & Morris, S. (2003) Cost of depression among adults in England in 2000. British Journal of
Psychiatry, 183, 514–519.
Agency for Health Care Policy and Research. Treatment for Depression - newer pharmocotherapies.
Summary, Evidence Report. Technology Assessment; 1999. Report No.7
UK Clinical Research Collaboration. From Donation to Innovation: An analysis of health research funded by
medium and smaller sized medical research charities. London: UKCRC. (www.ukcrc.org)
UK Clinical Research Collaboration. Progress Report 2006 – 2008. London: UKCRC.
Roberts, SH, Bedson, E, and Tranter, R (2010) Half-baked? B vitamins and depression. American Journal of
Clinical Nutrition, 92, 269-270
Roberts SH, Bedson E, Hughes D, et al, Folate Augmentation of Treatment – Evaluation for Depression
(FolATED): protocol of a randomised controlled trial, BMC Psychiatry , 2007, 7, 7-65
National Institute for Health & Clinical Excellence (2010). The Treatment And Management Of Depression
In Adults (Updated Edition). National Clinical Practice Guideline 90. London: The British Psychological
Society and The Royal College of Psychiatrists.
http://folated.bangor.ac.uk/
www.mhrnc.org
www.who.int/mental_health/management/depression/definition/en/
www.ukcrc.org
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