A double-blind randomized placebo-controlled study of low dose mirtazapine once daily in patients of major depressive disorders on escitalopram

Mallikarjuna Rao I.; Usha Kiran Prayaga; Dharma Rao Uppada; Ramachandra Rao E.; B. L. Kudagi

doi:10.18203/2319-2003.ijbcp20191602

Authors

Mallikarjuna Rao I. Department of Pharmacology, NMC, Nellore, Andhra Pradesh, India
Usha Kiran Prayaga Department of Pharmacology, RMC, Kakinada, Andhra Pradesh, India
Dharma Rao Uppada Clinical pharmacologist, VIMTA Labs Limited, Hyderabad, Telangana, India
Ramachandra Rao E. Department of Psychiatry, RMC, Kakinada, Andhra Pradesh, India
B. L. Kudagi Department of Pharmacology, NMC, Nellore, Andhra Pradesh, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20191602

Keywords:

Montgomery-asberg depression rating scale, Major depressive disorder, 17-item hamilton depression rating scale

Abstract

Background: The SSRIs being used as 1^st line therapy in treatment of depression have delayed therapeutic effect which makes the patient vulnerable to an increased risk of suicide and decreased adherence to the treatment and will prematurely discontinue the therapy. The present study was conducted to evaluate if low dose mirtazapine-escitalopram combination therapy has any add on benefit over monotherapy with escitalopram.

Methods: In a single-centered, comparative study involving patients with depression attending the out-patient after screening and exclusion, 60 eligible patients were randomly assigned to receive tablet mirtazapine 7.5 mg plus tablet escitalopram 10 mg intervention or tablet escitalopram 10 mg plus placebo intervention in a double-blind 6-week treatment phase. The primary outcome measure was the change in the 17-item Hamilton Depression Rating Scale (HDRS) and Montgomery-Asberg Depression Rating Scale (MADRS) score from baseline. Participants were evaluated at baseline, 1^st, 2^nd,4^th and 6^th week. Results were analyzed using Chi-Square test for adverse effects and independent t-test analysis for efficacy parameter.

Results: In the analysis of results at 6^th week the numbers of patients achieved remission in mirtazapine group are more with a p-value of 0.018 which is significant and the numbers of responders in mirtazapine group are also more which is statistically significant on chi-square test. There is no significant difference was observed between the two groups with reference to occurrence of adverse effect.

Conclusions: Adding low dose mirtazapine has an added benefit in terms of efficacy and getting remission early with more number of responders in the treatment of major depression.

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References

Reddy VM, Chandrashekar CR. Prevalence of mental and behavioural disorders in India: a meta-analysis. Ind J Psychiatry. 1998;40(2):149.

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. Brit J Psychiatry. 2000;176(4):351-6.

Sethi BB, Prakash R. Depression in Industrial population. Ind J Psychiatry. 1979;21(4):359.

Koda-Kimble MA, Alldredge BK. Applied therapeutics : the clinical use of drugs. 10th ed. Philadelphia: Wolters Kluwer/Lippincott Williams and Wilkins; 2013: 2519.

Reddy MS. Depression: the disorder and the burden. Ind J Psychol Med. 2010;32(1):1.

Anttila SA, Leinonen EV. A review of the pharmacological and clinical profile of mirtazapine. CNS Drug Rev. 2001;7(3):249-64.

Drugs@FDA: FDA Approved Drug Products-REMERON, Available at: https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=NandAppl_No=020415. Accessed 30 September 2018.

Papakostas GI, Homberger CH, Fava M. A meta-analysis of clinical trials comparing mirtazapine with selective serotonin reuptake inhibitors for the treatment of major depressive disorder. J Psychopharmacol. 2008;22(8):843-8.

Nierenberg AA, Keefe BR, Leslie VC, Alpert JE, Pava JA, Worthington III JJ, et al. Residual symptoms in depressed patients who respond acutely to fluoxetine. J Clin Psychiatry. 1999;60(4):221-5.

Matreja PS, Badyal DK, Deswal RS, Sharma A. Efficacy and safety of add on low-dose mirtazapine in depression. Ind J Pharmacol. 2012;44(2):173.

Carpenter LL, Yasmin S, Price LH. A double-blind, placebo-controlled study of antidepressant augementation with mirtazapine. Biol Psychiatry. 2002;51(2):183-8.

Blier P, Ward HE, Tremblay P, Laberge L, Hébert C, Bergeron R. Combination of antidepressant medications from treatment initiation for major depressive disorder: a double-blind randomized study. Am J Psychiatry. 2009;167(3):281-8.

Croom KF, Perry CM, Plosker GL. Mirtazapine. CNS Drugs. 2009;23(5):427-52.

Stimmel GL, Dopheide JA, Stahl SM. Mirtazapine: an antidepressant with noradrenergic and specific serotonergic effects. Pharmacotherapy J Human Pharmacol Drug Therapy. 1997;17(1):10-21.

Winokur A, Sateia MJ, Hayes JB, Bayles-Dazet W, MacDonald MM, Gary KA. Acute effects of mirtazapine on sleep continuity and sleep architecture in depressed patients: a pilot study. Biol Psychiatry. 2000;48(1):75-8.

Thase ME, Nierenberg AA, Vrijland P, Oers HJ, Schutte AJ, Simmons JH. Remission with mirtazapine and selective serotonin reuptake inhibitors: a meta-analysis of individual patient data from 15 controlled trials of acute phase treatment of major depression. Int Clin Psychopharmacol. 2010;25(4):189-98.

Laimer M, Kramer-Reinstadler K, Rauchenzauner M, Lechner-Schoner T, Strauss R, Engl J, Deisenhammer EA, et al. Effect of mirtazapine treatment on body composition and metabolism. J Clin Psychiatry. 2006;67(3):421-4.

Nicholas LM, Ford AL, Esposito SM, Ekstrom RD, Golden RN. The effects of mirtazapine on plasma lipid profiles in healthy subjects. J Clin Psychiatry. 2003;64(8):883-9.

Rush AJ, Trivedi MH, Stewart JW, Nierenberg AA, Fava M, Kurian BT, et al. Combining medications to enhance depression outcomes (CO-MED): acute and long-term outcomes of a single-blind randomized study. Am J Psychiatry. 2011;168(7):689-701.

Ogrodniczuk JS, Piper WE, Joyce AS. Residual symptoms in depressed patients who successfully respond to short-term psychotherapy. J Affective Dis. 2004;82(3):469-73.

Straten A, Hill J, Richards DA, Cuijpers P. Stepped care treatment delivery for depression: a systematic review and meta-analysis. Psychol Med. 2015;45(2):231-46.