DEPRESSION. Depression is common and has significant impact yrs. 18 days. taken off work during the last depressive episode1

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1 SS RIGA P SSRI-GAP

2 Depression is common and has significant impact1 1 in yrs 18 days 62 % South Africans in the workplace suffer from depression1 age group is most commonly affected, which represents the economic engine of the country1 taken off work during the last depressive episode1 of the total cost of depression in the US is attributable to workplace costs1* UNMET TREATMENT NEED < 40 % of patients treated with SSRIs, the most commonly used antidepressant monotherapy, achieve full remission3 Although the strategy of adding a second antidepressant may enhance efficacy, it comes with the risk of reduced tolerability3 * = data captured in 2000

3 Role of folate, vitamin D & vitamin B 12 in depression Deficiency Up to 1/3 of depressed patients have low plasma and red cell folate levels 4 Depressed patients are 2 x more likely to be vitamin D deficient 5 Low vitamin B 12 levels are found in depressed patients 2 Effect on treatment Low levels of folate and vitamin B 12 is associated with a poor response to antidepressants 2,7

4 Physiological effects of folate, vitamin D & vitamin B12 in depression Folate Vitamin B12 Required for the biosynthesis of 5-hydroxytryptamine and noradrenaline4 Plays an important role in neurological function7 Vitamin D May affect the cholinergic system6 Increases neurotrophic factors involved in depression5,6 Affects inflammatory pathways linked to depression5

5 SSRI-GAP SSRI-GAP assists in the maintenance of the essential nutrients that may be depleted as a result of depression and the treatment thereof 8 FOLIC ACID VITAMIN D VITAMIN B 12 AMOUNT PER SSRI-GAP CAPSULE (DOSAGE: 1 CAPSULE DAILY) 0.4 mg IU mg 8 DRI (DIETARY REFERENCE INDEX) OR RDA (RECOMMENDED DAILY ALLOWANCE) 1 mg* 9 70 years: 600 IU/day 9 > 70 years: 800 IU/day mg 11 OTHER SOURCES Leafy green vegetables, citrus fruits, wheat germ, yeast, liver, beans, legumes 3 Sunlight, oily fish, fortified food 10 Animal products, including fish, meat, poultry, eggs, milk, and milk products 11 *suggested intake - no specific dietary intake recommendation 10

6 SSRI-GAP SSRI-GAP assists in the maintenance of the essential nutrients that may be depleted as a result of depression and the treatment thereof8 DOSAGE & DIRECTIONS FOR USE Take one (1) capsule daily8 References: 1. Stander MP, Bergh M, Miller-Janson HE, et al. Depression in the South African workplace. S Afr J Psychiat 2016;22(1):a dx.doi org/ /sajpsychiatry.v22i Coppen A, Bolander-Gouaille C. Treatment of depression: time to consider folic acid and vitamin B12. J Psychopharmacol 2005;19(1): Morris DW, Trivedi MH, Rush AJ. Folate and unipolar depression. J Alt Comp Med 2008;14(3): 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;7:65. Doi: / X Milaneschi Y, Hoogendijk W, Lips P, et al. The association between low vitamin D and depressive disorders. Molec Pscyhiatr 2014;19: Khoraminya N, Tehrani-Doost M, Jazayeri S, et al. Therapeutic effects of vitamin D as adjunctive therapy to fluoxetine in patients with major depressive disorder. ANZJP 2012;47(3): Syed EU, Wasay M, Awan S. Vitamin B12 supplementation in treating major depressive disorder: a randomized controlled trial. Open Neurol J 2013;7: SSRI-GAP approved package insert, Ross CA, Taylor CL, Yaktine AL, et al (eds). Dietary Reference Intakes (DRIs): Dietary reference intakes for calcium and vitamin D. Institute of Medicine, National Academy of Sciences, [cited 2017 Apr 08]; Available from: Ferder M, Inserra F, Manucha W. The world pandemic of vitamin D deficiency could possibly be explained by cellular inflammatory response activity induced by the renin-angiotensin system. Am J Physiol Cell Physiol 2013;304:C1027-C Vitamin B12 health professional fact sheet. NIH Office of Dietary Supplements, [cited 2017 Apr 08]; Available from: SSRI-GAP Each capsule contains Vitamin B mg; Vitamin D3 800 IU; Folic acid 0,4 mg. Adcock Ingram Limited. Reg. No. 1949/034385/06. Private Bag X69, Bryanston, 2021, South Africa. Tel /2017