Role of vitamin B supplementation with Fluoxetine in treatment of depression: A randomized controlled clinical trial
Keywords:
Vitamin B, Fluoxetine, HDRS - Hamilton depression rating score
Abstract
Objective: To explore the change in antidepressant efficacy of Fluoxetine with vitamin B supplementation.
Methods : The present study is a Single Centre, Open Label, Active Controlled, Parallel, and Single Period 8- Week study of 53 patients. Patients are divided in to two groups Fluoxetine alone group which contain 26 patients and Fluoxetine plus vitamin B group which contain 27 patients, after recruitment they were followed up and assessed for CG Impression & on HDRS score and for objective assessment. The primary outcome was observed by improvement in HDRS scores. Response to treatment, and Reduction in HDRS score is analyzed by Un- paired t test.
Results: In study subjects clinically significant improvement was observed in fluoxetine plus neurotropic vitamins group as compared to fluoxetine alone group. However statistical analysis shows different results, unpaired t test when applied for the comparison of outcome in the two related samples, the t observed = 4.000. The t observed value falls out of the acceptance region t reference = 1.717. Therefore the null hypothesis stands valid.
Conclusion: Fluoxetine plus vitamin B supplementation is not superior to Fluoxetine alone, for moderate to severe cases of mental depression without psychotic symptoms.
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References
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12. Parker G, Gibson NA, Brotchie H, Heruc G, Rees AM, Hadzi-Pavlovic D. Omega-3 fatty acids and mood disorders. Am J Psychiatry. 2006 Jun; 163(6):969-78.
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19. Tiemeier H, van Tuijl HR, Hofman A, Meijer J, Kiliaan AJ, Breteler MM. Vitamin B12, folate, and homocysteine in depression: the Rotterdam Study. Am J Psychiatry. 2002 Dec; 159(12):2099-101. [PubMed]
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21. Robins Wahlin TB, Wahlin A, Winblad B, Bäckman L. The influence of serum vitamin B12 and folate status on cognitive functioning in very old age. Biol Psychol. 2001 Jun; 56(3):247-65. [PubMed]
22. Oh R, Brown DL. Vitamin B12 deficiency. Am Fam Physician. 2003 Mar 1; 67(5):979-86. [PubMed]
23. Hintikka J, Tolmunen T, Tanskanen A, Viinamäki H. High vitamin B12 level and good treatment outcome may be associated in major depressive disorder. BMC Psychiatry. 2003 Dec 2; 3:17. [PubMed]
24. Tiemeier H, van Tuijl HR, Hofman A, Meijer J, Kiliaan AJ, Breteler MM. Vitamin B12, folate, and homocysteine in depression: the Rotterdam Study. Am J Psychiatry. 2002 Dec;159(12):2099-101. [PubMed]
25. Hintikka J, Tolmunen T, Tanskanen A, Viinamäki H. High vitamin B12 level and good treatment outcome may be associated in major depressive disorder. BMC Psychiatry. 2003 Dec 2; 3:17. [PubMed]
26. Hvas AM, Juul S, Bech P, Nexø E. Vitamin B6 level is associated with symptoms of depression. Psychother Psychosom. 2004 Nov-Dec; 73(6):340-3. [PubMed]
27. Obeid R, McCaddon A, Herrmann W. The role of hyper homocysteinemia and B-vitamin deficiency in neurological and psychiatric diseases. Clin Chem Lab Med. 2007; 45(12):1590-606. [PubMed]
28. Sachdev PS, Parslow RA, Lux O, Salonikas C, Wen W, Naidoo D, Christensen H, Jorm AF. Relationship of homocysteine, folic acid and vitamin B12 with depression in a middle-aged community sample. Psychol Med. 2005 Apr; 35(4):529-38. [PubMed]
29. Icd 10-- World Health Organization. The ICD-10 Classification of mental and behavioural disorders; clinical descriptions and diagnostic guidelines. Genova: World Health Organization; 1992.
30. Hamilton M. A Rating scale for Depression. J Neurol Neurosurg Psychiatry 1962; 23: 56-62. [PubMed]
31. Hamilton M. Development of a rating scale for Primary Depressive Illness. Br. Soc Clin Psychol 1967:278-296. [PubMed]
32. Government of India- Health Information of India 2000 & 2001. Chapter 13. Health Insurance Statistics (13.04), New Delhi: Ministry of Health and Family Welfare, Government of India, 2001. [PubMed]
33. Various degrees of dementia in a selected group of gastrectomized patients with low serum B12. Acta Neurol Scand. 1977 May; 55(5):363-76. [PubMed]
34. Roos D, Willanger R. Various degrees of dementia in a selected group of gastrectomized patients with low serum B12. Acta Neurol Scand. 1977 May; 55(5):363-76. [PubMed]
35. Brief communication. Vitamin B1, B2, and B6 augmentation of tricyclic antidepressant treatment in geriatric depression with cognitive dysfunction. Bell IR, Edman JS, Morrow FD, Marby DW, Perrone G, Kayne HL, Greenwald M, Cole JO. J Am Coll Nutr.1992 Apr; 11(2):159-63.
36. Dimopoulos N, Piperi C, Salonicioti A, Psarra V, Gazi F, Papadimitriou A, Lea RW, Kalofoutis A. Correlation of folate, vitamin B12 and homocysteine plasma levels with depression in an elderly Greek population. Clin Biochem. 2007 Jun; 40(9-10):604-8. Epub 2007 Jan 26. [PubMed]
37. Kim JM, Stewart R, Kim SW, Yang SJ, Shin IS, Yoon JS. Predictive value of folate, vitamin B12 and homocysteine levels in late-life depression. Br J Psychiatry. 2008 Apr; 192(4):268-74. doi: 10.1192/bjp.bp.107.039511. [PubMed]
38. Ng TP, Feng L, Niti M, Kua EH, Yap KB. Folate, vitamin B12, homocysteine, and depressive symptoms in a population sample of older Chinese adults. J Am Geriatr Soc. 2009 May; 57(5):871-6. [PubMed]
39. Sánchez-Villegas A, Doreste J, Schlatter J, Pla J, Bes-Rastrollo M, Martínez-González MA. Association between folate, vitamin B (6) and vitamin B (12) intake and depression in the SUN cohort study. J Hum Nutr Diet. 2009 Apr; 22(2):122-33. doi: 10.1111/j.1365-277X.2008.00931.x. Epub 2009 Jan 16. [PubMed]
40. Beydoun MA, Shroff MR, Beydoun HA, Zonderman AB. Serum folate, vitamin B-12, and homocysteine and their association with depressive symptoms among U.S. adults. Psychosom Med. 2010 Nov;72(9):862-73. doi: 10.1097/PSY.0b013e3181f61863. Epub 2010 Sep 14. [PubMed]
41. Lerner V, Kanevsky M, Dwolatzky T, Rouach T, Kamin R, Miodownik C. Vitamin B12 and folate serum levels in newly admitted psychiatric patients. Clin Nutr. 2006 Feb;25(1):60-7. Epub 2005 Oct 10. [PubMed]
42. Sachdev PS, Parslow RA, Lux O, Salonikas C, Wen W, Naidoo D, Christensen H, Jorm AF. Relationship of homocysteine, folic acid and vitamin B12 with depression in a middle-aged community sample. Psychol Med. 2005 Apr; 35(4):529-38. [PubMed]
43. Skarupski KA, Tangney C, Li H, Ouyang B, Evans DA, Morris MC. Longitudinal association of vitamin B-6, folate, and vitamin B-12 with depressive symptoms among older adultsover time. Am J Clin Nutr. 2010 Aug; 92(2):330-5. doi: 10.3945/ajcn.2010.29413. Epub 2010 Jun 2. [PubMed]
44. Murakami K, Mizoue T, Sasaki S, Ohta M, Sato M, Matsushita Y, Mishima N. Dietary intake of folate, other B vitamins, and omega-3 polyunsaturated fatty acids in relation to depressive symptoms in Japanese adults. Nutrition. 2008 Feb; 24(2):140-7. Epub 2007 Dec 3.
45. Walker JG, Mackinnon AJ, Batterham P, Jorm AF, Hickie I, McCarthy A, Fenech M, Christensen H. Mental health literacy, folic acid and vitamin B12, and physical activity for the prevention of depression in older adults: randomised controlled trial. Br J Psychiatry. 2010 Jul; 197(1):45-54. doi: 10.1192/bjp.bp.109.075291.
2. WHO (World Health Organization). Investing in mental health. Department of mental health and substance dependence, non communicable diseases and mental health. Geneva: World Health Organization; 2003. [PubMed]
3. Reddy VM, Chandrashekar CR. Prevalence of mental and behavioural disorders in India : a meta-analysis. Indian J Psychiatry. 1998 Apr; 40(2):149-57. [PubMed]
4. Nandi DN, Banerjee G, Mukherjee SP, Ghosh A, Nandi PS, Nandi S. Psychiatric morbidity of a rural Indian community. Changes over a 20-year interval. Br J Psychiatry. 2000 Apr; 176:351-6. [PubMed]
5. Sethi BB, Prakash R. Depression in Industrial population. Indian J Psychiatry.1979; 21:359–61.
6. American Psychiatric Association; Practice Guideline for the Treatment of Patients With Major Depressive Disorder, 3rd ed. DOI10.1176/appi.books.9780890423387.654001.
7. Thase ME, Entsuah AR, Rudolph RL. Remission rates during treatment with venlafaxine or selective serotonin reuptake inhibitors. Br J Psychiatry. 2001 Mar; 178:234-41. [PubMed]
8. Puech A, Montgomery SA, Prost JF, Solles A, Briley M. Milnacipran, a new serotonin and noradrenaline reuptake inhibitor: an overview of its antidepressant activity and clinical tolerability. Int Clin Psychopharmacol. 1997 Mar;12(2):99-108.
9. Antai-Otong D. The art of prescribing. Monotherapy antidepressant: a thing of the past? Implications for the treatment of major depressive disorder. Perspect Psychiatr Care. 2007 Jul; 43(3):142-5.
10. Pezawas L, Meyer-Lindenberg A, Goldman AL, Verchinski BA, Chen G, Kolachana BS, Egan MF, Mattay VS, Hariri AR, Weinberger DR. Evidence of biologic epistasis between BDNF and SLC6A4 and implications for depression. Mol Psychiatry. 2008 Jul; 13(7):709-16. doi: 10.1038/mp.2008.32. Epub 2008 Mar 18. [PubMed]
11. Ruhé HG, Mason NS, Schene AH. Mood is indirectly related to serotonin, norepinephrine and dopamine levels in humans: a meta-analysis of monoamine depletion studies. Mol Psychiatry. 2007 Apr; 12(4):331-59. Epub 2007 Jan 16. [PubMed]
12. Parker G, Gibson NA, Brotchie H, Heruc G, Rees AM, Hadzi-Pavlovic D. Omega-3 fatty acids and mood disorders. Am J Psychiatry. 2006 Jun; 163(6):969-78.
13. Kim JM, Stewart R, Kim SW, Yang SJ, Shin IS, Yoon JS. Predictive value of folate, vitamin B12 and homocysteine levels in late-life depression. Br J Psychiatry. 2008 Apr; 192(4):268-74. doi: 10.1192/bjp.bp.107.039511. [PubMed]
14. Rao NP, Kumar NC, Raman BR, Sivakumar PT, Pandey RS. Role of vitamin B12 in depressive disorder--a case report. Gen Hosp Psychiatry. 2008 Mar-Apr; 30(2):185-6. doi: 10.1016/j.genhosppsych.2007.09.002. [PubMed]
15. Dagnelie PC. [Nutrition and health--potential health benefits and risks of vegetarianism and limited consumption of meat in the Netherlands]. Ned Tijdschr Geneeskd. 2003 Jul 5; 147(27):1308-13. [PubMed]
16. Clement L, Boylan M, Miller VG, Rockwell M, Allred K. Serum levels of folate and cobalamin are lower in depressed than in non depressed hemodialysis subjects. J Ren Nutr. 2007 Sep; 17(5):343-9. [PubMed]
17. Hutto BR. Folate and cobalamin in psychiatric illness. Compr Psychiatry. 1997 Nov-Dec; 38(6):305-14. [PubMed]
18. Kamphuis MH, Geerlings MI, Grobbee DE, Kromhout D. Dietary intake of B (6-9-12) vitamins, serum homocysteine levels and their association with depressive symptoms: the Zutphen Elderly Study. Eur J Clin Nutr. 2008 Aug; 62(8):939-45. Epub 2007 May 30.
19. Tiemeier H, van Tuijl HR, Hofman A, Meijer J, Kiliaan AJ, Breteler MM. Vitamin B12, folate, and homocysteine in depression: the Rotterdam Study. Am J Psychiatry. 2002 Dec; 159(12):2099-101. [PubMed]
20. Penninx BW, Guralnik JM, Ferrucci L, Fried LP, Allen RH, Stabler SP. Vitamin B (12) deficiency and depression in physically disabled older women: epidemiologic evidence from the Women's Health and Aging Study. Am J Psychiatry. 2000 May; 157(5):715-21.
21. Robins Wahlin TB, Wahlin A, Winblad B, Bäckman L. The influence of serum vitamin B12 and folate status on cognitive functioning in very old age. Biol Psychol. 2001 Jun; 56(3):247-65. [PubMed]
22. Oh R, Brown DL. Vitamin B12 deficiency. Am Fam Physician. 2003 Mar 1; 67(5):979-86. [PubMed]
23. Hintikka J, Tolmunen T, Tanskanen A, Viinamäki H. High vitamin B12 level and good treatment outcome may be associated in major depressive disorder. BMC Psychiatry. 2003 Dec 2; 3:17. [PubMed]
24. Tiemeier H, van Tuijl HR, Hofman A, Meijer J, Kiliaan AJ, Breteler MM. Vitamin B12, folate, and homocysteine in depression: the Rotterdam Study. Am J Psychiatry. 2002 Dec;159(12):2099-101. [PubMed]
25. Hintikka J, Tolmunen T, Tanskanen A, Viinamäki H. High vitamin B12 level and good treatment outcome may be associated in major depressive disorder. BMC Psychiatry. 2003 Dec 2; 3:17. [PubMed]
26. Hvas AM, Juul S, Bech P, Nexø E. Vitamin B6 level is associated with symptoms of depression. Psychother Psychosom. 2004 Nov-Dec; 73(6):340-3. [PubMed]
27. Obeid R, McCaddon A, Herrmann W. The role of hyper homocysteinemia and B-vitamin deficiency in neurological and psychiatric diseases. Clin Chem Lab Med. 2007; 45(12):1590-606. [PubMed]
28. Sachdev PS, Parslow RA, Lux O, Salonikas C, Wen W, Naidoo D, Christensen H, Jorm AF. Relationship of homocysteine, folic acid and vitamin B12 with depression in a middle-aged community sample. Psychol Med. 2005 Apr; 35(4):529-38. [PubMed]
29. Icd 10-- World Health Organization. The ICD-10 Classification of mental and behavioural disorders; clinical descriptions and diagnostic guidelines. Genova: World Health Organization; 1992.
30. Hamilton M. A Rating scale for Depression. J Neurol Neurosurg Psychiatry 1962; 23: 56-62. [PubMed]
31. Hamilton M. Development of a rating scale for Primary Depressive Illness. Br. Soc Clin Psychol 1967:278-296. [PubMed]
32. Government of India- Health Information of India 2000 & 2001. Chapter 13. Health Insurance Statistics (13.04), New Delhi: Ministry of Health and Family Welfare, Government of India, 2001. [PubMed]
33. Various degrees of dementia in a selected group of gastrectomized patients with low serum B12. Acta Neurol Scand. 1977 May; 55(5):363-76. [PubMed]
34. Roos D, Willanger R. Various degrees of dementia in a selected group of gastrectomized patients with low serum B12. Acta Neurol Scand. 1977 May; 55(5):363-76. [PubMed]
35. Brief communication. Vitamin B1, B2, and B6 augmentation of tricyclic antidepressant treatment in geriatric depression with cognitive dysfunction. Bell IR, Edman JS, Morrow FD, Marby DW, Perrone G, Kayne HL, Greenwald M, Cole JO. J Am Coll Nutr.1992 Apr; 11(2):159-63.
36. Dimopoulos N, Piperi C, Salonicioti A, Psarra V, Gazi F, Papadimitriou A, Lea RW, Kalofoutis A. Correlation of folate, vitamin B12 and homocysteine plasma levels with depression in an elderly Greek population. Clin Biochem. 2007 Jun; 40(9-10):604-8. Epub 2007 Jan 26. [PubMed]
37. Kim JM, Stewart R, Kim SW, Yang SJ, Shin IS, Yoon JS. Predictive value of folate, vitamin B12 and homocysteine levels in late-life depression. Br J Psychiatry. 2008 Apr; 192(4):268-74. doi: 10.1192/bjp.bp.107.039511. [PubMed]
38. Ng TP, Feng L, Niti M, Kua EH, Yap KB. Folate, vitamin B12, homocysteine, and depressive symptoms in a population sample of older Chinese adults. J Am Geriatr Soc. 2009 May; 57(5):871-6. [PubMed]
39. Sánchez-Villegas A, Doreste J, Schlatter J, Pla J, Bes-Rastrollo M, Martínez-González MA. Association between folate, vitamin B (6) and vitamin B (12) intake and depression in the SUN cohort study. J Hum Nutr Diet. 2009 Apr; 22(2):122-33. doi: 10.1111/j.1365-277X.2008.00931.x. Epub 2009 Jan 16. [PubMed]
40. Beydoun MA, Shroff MR, Beydoun HA, Zonderman AB. Serum folate, vitamin B-12, and homocysteine and their association with depressive symptoms among U.S. adults. Psychosom Med. 2010 Nov;72(9):862-73. doi: 10.1097/PSY.0b013e3181f61863. Epub 2010 Sep 14. [PubMed]
41. Lerner V, Kanevsky M, Dwolatzky T, Rouach T, Kamin R, Miodownik C. Vitamin B12 and folate serum levels in newly admitted psychiatric patients. Clin Nutr. 2006 Feb;25(1):60-7. Epub 2005 Oct 10. [PubMed]
42. Sachdev PS, Parslow RA, Lux O, Salonikas C, Wen W, Naidoo D, Christensen H, Jorm AF. Relationship of homocysteine, folic acid and vitamin B12 with depression in a middle-aged community sample. Psychol Med. 2005 Apr; 35(4):529-38. [PubMed]
43. Skarupski KA, Tangney C, Li H, Ouyang B, Evans DA, Morris MC. Longitudinal association of vitamin B-6, folate, and vitamin B-12 with depressive symptoms among older adultsover time. Am J Clin Nutr. 2010 Aug; 92(2):330-5. doi: 10.3945/ajcn.2010.29413. Epub 2010 Jun 2. [PubMed]
44. Murakami K, Mizoue T, Sasaki S, Ohta M, Sato M, Matsushita Y, Mishima N. Dietary intake of folate, other B vitamins, and omega-3 polyunsaturated fatty acids in relation to depressive symptoms in Japanese adults. Nutrition. 2008 Feb; 24(2):140-7. Epub 2007 Dec 3.
45. Walker JG, Mackinnon AJ, Batterham P, Jorm AF, Hickie I, McCarthy A, Fenech M, Christensen H. Mental health literacy, folic acid and vitamin B12, and physical activity for the prevention of depression in older adults: randomised controlled trial. Br J Psychiatry. 2010 Jul; 197(1):45-54. doi: 10.1192/bjp.bp.109.075291.
CITATION
DOI: 10.17511/ijmrr.2016.i01.014
Published: 2016-01-31
How to Cite
1.
Kuchya S, Gedam S, Lakhwani L. Role of vitamin B supplementation with Fluoxetine in treatment of depression: A randomized controlled clinical trial. Int J Med Res Rev [Internet]. 2016Jan.31 [cited 2024Nov.23];4(1):90-6. Available from: https://ijmrr.medresearch.in/index.php/ijmrr/article/view/438
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Original Article
OAI - Open Archives Initiative
