A COMPARATIVE STUDY OF EFFICACY AND SAFETY OF ORAL SODIUM VALPROATE VERSUS DIVALPROEX IN TREATMENT OF BIPOLAR DISORDER
Main Article Content
Keywords
Bipolar disorder, Sodium valproate, Divalproex, Mood stabilizers etc
Abstract
Background: Bipolar disorder is a prevalent psychiatric condition that significantly impacts the quality of life, characterized by recurring episodes of mania, hypomania, and depression. Sodium Valproate and Divalproex are two commonly prescribed mood stabilizers for managing bipolar disorder. This study aims to evaluate the efficacy and safety of these drugs in the treatment of bipolar disorder, given the limited data from Central India.
Methods: A prospective, observational study was conducted involving 110 patients diagnosed with bipolar disorder. Participants were divided into two groups: Group I received Sodium Valproate (500mg twice daily), and Group II received Divalproex (500mg twice daily). Treatment efficacy was measured using the Young Mania Rating Scale (YMRS) and Bipolar Depression Rating Scale (BDRS) at baseline, 6 weeks, and 8 weeks. The severity and causality of adverse drug reactions were assessed using the Hartwig Severity Scale and WHO UMC Causality Assessment Scale.
Results: Both drugs showed significant improvement in YMRS and BDRS scores over the 8-week period. Sodium Valproate resulted in a 53.39% reduction in YMRS and a 52.44% reduction in BDRS scores, while Divalproex showed slightly better efficacy with a 54.13% reduction in YMRS and a 53.33% reduction in BDRS scores. P value was calculated using the software Spss 30. Significant p value was found for each group. Both drugs were well tolerated, with mild adverse effects such as nausea and tremors being the most commonly reported.
Conclusion: Sodium Valproate and Divalproex are effective and safe options for managing bipolar disorder, with Divalproex showing a marginally better efficacy profile. These findings contribute to the understanding of bipolar disorder treatment in Central India and provide insights into the comparative effectiveness of these mood stabilizers
References
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7. Sentissi O, Popovic D, Moeglin C, Stukalin YB, Mosheva M, Vieta E,Serretti A, Souery D. Predominant polarity in bipolar disorder patients:the COPE bipolar sample. Journal of affective disorders. 2019 May 1;250:43-50.
8. Goodwin, G.. 2018. Hypomania: What's in a name? Br. J. Psychiatry 181.94-95. Gordovez,
F.J.A., McMahon, F.J.. 2020, Y the geneties of bipolar disorder. Mol. Pyvchuatrs 25. 544-559.
9. Schaffer A, Isometsä ET, Tondo L, H Moreno D, Turecki G, Reis C, Cassidy F, Sinyor M, Azorin JM, Kessing LV, Ha K. International Societyfor Bipolar Disorders Task Force on Suicide: meta-analyses and meta- regression of correlates of suicide attempts and suicide deaths in bipolar disorder. Bipolar disorders. 2015 Feb;17(1):1-6.
10. Rantala MJ, Luoto S, Borráz-León JI, Krams I. Bipolar disorder: An evolutionary psychoneuroimmunological approach. Neuroscience & Biobehavioral Reviews. 2021 Mar 1;122:28-37.
11. Post RM. The impact of bipolar depression. Journal of ClinicalPsychiatry. 2005 Jan 1;66(5):5.
12. Sodium valproate: medicine to treat epilepsy and bipolar disorder. (n.d.).nhs.uk. Retrieved May 8, 2024, from https://www.nhs.uk/medicines/ sodium-valproate/
13. Godman B, Grobler C, Van-De-Lisle M, Wale J, Barbosa WB, Massele A,Opondo P, Petrova G, Tachkov K, Sefah I, Abdulsalim S. Pharmacotherapeutic interventions for bipolar disorder type II: addressing multiple symptoms and approaches with a particular emphasis on strategies in lower and middle-income countries. Expert opinion on pharmacotherapy. 2019 Dec 12;20(18):2237-55.
14. Chokhawala K, Stevens L. Antipsychotic Medications. [Updated 2023Feb 26]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from:
15. Falret JP. Circular madness or form of mental illness characterized by theregular alternation of mania and melancholy. Bull Acad Med (Paris). 1851.
16. Baillarger J. Madness in two forms. Ann med psychol. 1854;6:367-91.
17. Akiskal HS. Subaffective Disorders: Dysthymic, Cyclothymic and Bipolar II Disorders in the “; Borderline” Realm. Psychiatric clinics. 1981Apr 1;4(1):25-46.
18. Angst J, Marneros A. Bipolarity from ancient to modern times:: conception, birth and rebirth. Journal of affective disorders. 2001 Dec1;67(1-3):3-19.
19. Mason BL, Brown ES, Croarkin PE. Historical underpinnings of bipolardisorder diagnostic criteria. Behavioral Sciences. 2016 Jul 15;6(3):14.
20. Lamb S. Social skills: Adolf Meyer’s revision of clinical skill for the newpsychiatry of the twentieth century. Medical history. 2015 Jul;59(3):443-64.
21. Paykel ES. Basic concepts of depression. Dialogues in clinicalneuroscience. 2008 Sep 30;10(3):279-89.
22. Özdemir O, Coşkun S, Mutlu EA, Özdemir PG, Abdullah AT, Yilmaz E,Keskin S. Family history in patients with bipolar disorder.Archives of Neuropsychiatry. 2016 Sep;53(3):276.
23. 2024 ICD-10-CM diagnosis code F31.30. (n.d.). .Retrieved June 18, 2024, from Codes/F01- F99/F30-F39/F31-/F31.30
24. Geddes JR, Miklowitz DJ. Treatment of bipolar disorder. The lancet. 2013May 11;381(9878):1672-82.
25. Novick DM, Swartz HA. Evidence-based psychotherapies for bipolardisorder. FOCUS, A Journal of the American Psychiatric Association.2019 Jul;17(3):238-48.
26. Baldessarini RJ, Bolzani L, Cruz N, Jones PB, Lai M, Lepri B, Perez J, Salvatore P, Tohen M, Tondo L, Vieta E. Onset-age of bipolar disorders atsix international sites. J Affect Disord. 2010 Feb;121(1-2):143-6. doi: 10.1016/j.jad.2009.05.030. Epub 2009 Jun 28. PMID: 19560827.
27. Fountoulakis KN, Tohen M, Zarate CA Jr. Lithium treatment of Bipolardisorder in adults: A systematic review of randomized trials and meta- analyses. Eur Neuropsychopharmacol. 2022 Jan;54:100-115. doi: 10.1016/j.euroneuro.2021.10.003. PMID: 34980362; PMCID: PMC8808297.
28. Angus-Leppan H, Arkell R, Watkins L, Heaney D, Cooper P, Shankar R.New valproate regulations, informed choice and seizure risk. Journal of Neurology. 2024 Jun 19:1-6.
29. Anmella G, et al. Expert advice on the management of valproate inwomen with bipolar disorder at childbearing age. Eur Neuropsychopharmacol, 2019, 29:1199–1212.
30. Post RM, et al. Thirty years of clinical experience with carbamazepine in the treatment of bipolar illness: principles and practice. CNS Drugs, 2007,21:47–71.
31. Wingård L, et al. Monotherapy vs. combination therapy for post maniamaintenance treatment: a population based cohort study. Eur Neuropsychopharmacol, 2019, 29:691–700.
32. Kook KA, et al. Accuracy and safety of a priori lithium loading. J ClinPsychiatry, 1985, 46:49– 51
33. Awan S, Abelleira A, Khehra L, Hieber R. Undetectable serum lithium concentrations after coadministration of liquid lithium citrate and applejuice: A case report. Mental Health Clinician. 2021 Jan 1;11(1):27-30.
34. Brunton LL, Knollmann BC, editors. Goodman & Gilman’s the pharmacological basis of therapeutics. Fourteenth edition. New York:McGraw Hill; 2023. 1 p.
35. Anderson IM. Selective serotonin reuptake inhibitors versus tricyclic antidepressants: a meta- analysis of efficacy and tolerability. Journal ofaffective disorders. 2000 Apr 1;58(1):19-36.
36. Hillhouse TM, Porter JH. A brief history of the development of antidepressant drugs: from monoamines to glutamate. Experimental andclinical psychopharmacology. 2015 Feb;23(1):1.
37. PubChem. (n.d.). Valproate Sodium. nih.gov. Retrieved June 15, 2024,from https:// pubchem.ncbi.nlm.nih.gov/compound/Valproate-Sodium
38. El-Habr EA, Dubois LG, Burel-Vandenbos F, Bogeas A, Lipecka J, Turchi L, Lejeune FX, Coehlo PL, Yamaki T, Wittmann BM, Fareh M. Adriver role for GABA metabolism in controlling stem and proliferative cell state through GHB production in glioma. Acta neuropathologica. 2017 Apr;133:645-60.
39. Rosenberg G. The mechanisms of action of valproate in neuropsychiatric disorders: can we see the forest for the trees?. Cellular and Molecular LifeSciences. 2007 Aug;64(16):2090-103.
40. Yamada MK, Nakanishi K, Ohba S, Nakamura T, Ikegaya Y, Nishiyama N, Matsuki N: Brain- derived neurotrophic factor promotes the maturationof GABAergic mechanisms in cultured hippocampal neurons. J Neurosci.2002 Sep 1;22(17):7580-5
41. Dreifuss FE, et al. Valproic acid hepatic fatalities. II. U.S. experiencesince1984. Neurology, 1989, 39:201–207.
42. Khandelwal A, Mahajan C, Prabhakar H. Anti-epileptic drugs (AEDs). Pharmacology in Clinical Neurosciences: AQuick Guide. 2020:173-256.
43. Brunton LL, Knollmann BC, editors. Goodman & Gilman’s the pharmacological basis of therapeutics. Fourteenth edition. New York:McGraw Hill; 2023. 1 p.
44. KD Tripathi Essentials of Medical Pharmacology, 8th edition, pageno.444-445, Jaypee Brothers: New Delhi, 2018.
45. Löscher W. Basic pharmacology of valproate: a review after 35 years ofclinical use for the treatment of epilepsy. CNS Drugs.2002;16(10):669-94
46. Faingold CL, Browning RA. Mechanisms of anticonvulsant drug action. II. Drugs primarily used for absence epilepsy. Eur J Pediatr. 1987Jan;146(1):8-14.
47. PubChem. (n.d.-a). Divalproex Sodium. nih.gov. Retrieved June 15, 2024,from https:// pubchem.ncbi.nlm.nih.gov/compound/Divalproex-Sodium
48. Davis LL, Williams R, Cates M. Divalproex sodium in the treatment ofadults with bipolar disorder. Expert Review of Neurotherapeutics. 2004May 1;4(3):349-62.
49. Berridge MJ, Downes CP, Hanley MR. Neural and developmental actionsof lithium: a unifying hypothesis. Cell. 1989 Nov 03;59(3):411-9.
50. Kerr F, Bjedov I, Sofola-Adesakin O. Molecular Mechanisms of LithiumAction: Switching the Light on Multiple Targets for Dementia Using Animal Models. Front Mol Neurosci. 2018;11:297.
51. Lubrich B, van Calker D. Inhibition of the high affinity myo-inositol transport system: a common mechanism of action of antibipolar drugs?Neuropsychopharmacology. 1999 Oct;21(4):519-29.
52. Chen G, Pan B, Hawver DB, Wright CB, Potter WZ, Manji HK. Attenuation of cyclic AMP production by carbamazepine. J Neurochem.1996 Nov;67(5):2079-86.
53. Cunningham MO, Jones RS. The anticonvulsant, lamotrigine decreases spontaneous glutamate release but increases spontaneous GABA releasein the rat entorhinal cortex in vitro. Neuropharmacology. 2000 Aug 23;39(11):2139-46.
54. Solanki RK, Singh P, Khandelwal R, Midha A. Efficacy and tolerabilityof injectable sodium valproate in patients with mania. Indian Journal ofPsychiatry. 2006Apr 1;48(2):118-20.
55. Muzina, D. J., Gao, K., Kemp, D. E., Khalife, S., Ganocy, S. J., Chan, P.K.,Serrano, M. B., Conroy, C. M., & Calabrese, J. R. (2011). Acute efficacysof divalproex sodium versus placebo in mood stabilizer– naive bipolar I orII depression: Double-blind, randomized, placebo- controlled trial. TheJournal of Clinical Psychiatry, 72(06), 813–819.
56. Soni A, Singh P, Kumar S, Shah R, Batra L, Verma M. Role of age at onset in the clinical presentation of bipolar disorder in Indian population.Industrial psychiatry journal. 2021 Jan 1;30(1):41-6.
57. Bipolar disorder. (n.d.). National Institute of Mental Health (NIMH).Retrieved June 19, 2024, from
58. Hochman E, Valevski A, Onn R, Weizman A, Krivoy A. Seasonal patternof manic episode admissions among bipolar I disorder patients is associated with male gender and presence of psychotic features. Journal of affective disorders. 2016 Jan 15;190:123-7.
59. Antypa N, Serretti A. Family history of a mood disorder indicates a moresevere bipolar disorder. J Affect Disord. 2014 Mar;156:178-86. doi: 10.1016/j.jad.2013.12.013. Epub 2013 Dec 18. PMID: 24439249
60. Delage C, Palayer M, Etain B, Hagenimana M, Blaise N, Smati J, Chouchana M, Bloch V, Besson VC. Valproate, divalproex, valpromide:Are the differences in indications justified?. Biomedicine & Pharmacotherapy. 2023 Feb 1;158:114051.
61. Talaei A, Dastgheib MS, Soltanifar A, Mokhber N, Akhondzadeh S, Afzaljavan F. Oxcarbazepine versus sodium valproate in treatment ofacute mania: a double-blind randomized clinical trial. International Clinical Psychopharmacology. 2022 May 1;37(3):116-21..
62. Chaurasia L, Shah SK, Chetty SM. Efficacy of Sodium Valproate and Olanzapine in treating bipolar affective disorder'mania'at a tertiary carehospital in Nepal: A comparative study. Janaki Medical College Journalof Medical Science. 2016;4(1):27-35.
63. Shansis FM, Reche M, Capp E. Evaluating response to mood stabilizersin patients with mixed depression: a study of agreement between three different mania rating scales and a depression rating scale. Journal of Affective Disorders. 2016 Jun 1;197:1-7.
64. Bowden CL, Mosolov S, Hranov L, Chen E, Habil H, Kongsakon R, Manfredi R, Lin HN. Efficacy of valproate versus lithium in mania ormixed mania: a randomized, open 12-week trial. International clinicalpsychopharmacology. 2010 Mar 1;25(2):60-7.
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Oct 25, 2024
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Dr. Abhishek Madhu Paserkar, Dr. J.L. Marko, Dr. Ruchi Soni, Dr. Muskan Khare, & Dr. Jayesh Rajgopal. (2024). A COMPARATIVE STUDY OF EFFICACY AND SAFETY OF ORAL SODIUM VALPROATE VERSUS DIVALPROEX IN TREATMENT OF BIPOLAR DISORDER. Journal of Population Therapeutics and Clinical Pharmacology, 31(10), 518-538. https://doi.org/10.53555/r11db220
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Author Biographies
Dr. Abhishek Madhu Paserkar
Dept. of Pharmacology and Dept. of Psychiatry Gandhi Medical College and Hospitals, Bhopal, Madhya Pradesh, India
Dr. J.L. Marko
Dept. of Pharmacology and Dept. of Psychiatry Gandhi Medical College and Hospitals, Bhopal, Madhya Pradesh, India
Dr. Ruchi Soni
Dept. of Pharmacology and Dept. of Psychiatry Gandhi Medical College and Hospitals, Bhopal, Madhya Pradesh, India
Dr. Muskan Khare
Dept. of Pharmacology and Dept. of Psychiatry Gandhi Medical College and Hospitals, Bhopal, Madhya Pradesh, India
Dr. Jayesh Rajgopal
Dept. of Pharmacology and Dept. of Psychiatry Gandhi Medical College and Hospitals, Bhopal, Madhya Pradesh, India
How to Cite
Dr. Abhishek Madhu Paserkar, Dr. J.L. Marko, Dr. Ruchi Soni, Dr. Muskan Khare, & Dr. Jayesh Rajgopal. (2024). A COMPARATIVE STUDY OF EFFICACY AND SAFETY OF ORAL SODIUM VALPROATE VERSUS DIVALPROEX IN TREATMENT OF BIPOLAR DISORDER. Journal of Population Therapeutics and Clinical Pharmacology, 31(10), 518-538. https://doi.org/10.53555/r11db220