Safety and efficacy of the Deprilium<sup>®</sup> complex in reducing subclinical symptoms of depression in patients with chronic non-communicable diseases: a double-blind, randomized controlled trial | Ukrainian Medical Journal

Chaban O.S.,Khaustоva O.O.,Assonov D.О.

Main
Publications
Safety and efficacy of the Deprilium^® complex in reducing subclinical symptoms of depression in patients with chronic non-communicable diseases: a double-blind, randomized controlled trial

Safety and efficacy of the Deprilium^® complex in reducing subclinical symptoms of depression in patients with chronic non-communicable diseases: a double-blind, randomized controlled trial

April 27, 2022

1158

Allergology and Pulmonology

Cardiology, Rheumatology

Neurology and Psychiatry

Therapy, General practice

Keywords :

chronic non-communicable diseases,

depression,

S-adenosyl-L-methionine

Specialities :

Allergology and Pulmonology

Cardiology, Rheumatology

Neurology and Psychiatry

Therapy, General practice

Endocrinology

Resume

Topicality. Currently, there is a need to find approaches to early treatment of depressive symptoms in patients with chronic non-communicable diseases, which would allow to begin management of symptoms at the beginning of their occurrence. A promising candidate for the role of such therapy may be the complex Deprilium^®, which contains S-adenosyl-L-methionine (SAMe), L-methylfolate and methylcobalamin.

The aim: to evaluate the effectiveness of Deprilium^® in relieving subclinical symptoms of depression in patients with chronic non-communicable diseases.

Materials and methods. Study design: a double-blind randomized controlled trial with parallel groups. On the basis of the Department of Medical Psychology, Psychosomatic Medicine and Psychotherapy of the O.O. Bogomolets National Medical University (monocentric study) in compliance with ethical and deontological norms in accordance with the principles set out in the Declaration of Helsinki, involved 140 patients. The Hamilton Depression Scale (HAM-D) was used to assess subclinical symptoms. The somatic symptoms scale (SSS-8) and the O.S. Chaban quality of life scale (QOLS) were used to obtain additional information about the patient’s condition. Patients were randomized to block randomization in the Deprilium^® study group and the placebo control group.

Results. After 60 days (T2), there was a statistically significant difference in all clinical parameters between the study group and the control group. The median value of the HAM-D scale differed between groups by 6 points, significantly (p<0.000) lower results were observed in the study group, which participants took the Deprilium^® complex. When comparing the indicators of the study group on day 1 (T1) and 60 days (T2) of participation in the study, statistically significant changes (p<0.000) were observed in all three indicators.

Conclusion. Our results confirm the available evidence for the effectiveness of SAMe as a therapy for depression and complement their evidence of the effectiveness of the Deprilium^® complex containing SAMe and L-methylfolate with methylcobalamin, which together cause pharmacological and clinical synergism for synergism, in subclinical depressive manifestations in patients with common chronic non-communicable diseases. In addition, it was found that taking the Deprilium^® complex for 2 months does not contain an increased risk to patient health and significant side effects. Further studies of the effectiveness of Deprilium^® in patients with chronic non-communicable diseases are needed.

References

1. Fava M., Giannelli A., Rapisarda V. et al. (1995) Rapidity of onset of the antidepressant effect of parenteral. Psychiatry Research, 56(3): 295–297.
2. Mukeshimana M., Mchunu G. (2017) Management of Co-Morbidity of Depression and Chronic Non-Communicable Diseases in Rwanda. Ethiopian journal of health sciences, 27(1): 17–26. https://doi.org/10.4314/ejhs.v27i1.4
3. Unützer J., Harbin H., Schoenbaum M., Druss B. (2013) The collaborative care model: An approach for integrating physical and mental health care in Medicaid health homes. Health Home Information Resource Center, 1–13.
4. Anwar N., Kuppili P.P., Balhara Y.P.S. (2018) Depression and physical noncommunicable diseases: the need for an integrated approach. WHO South-East Asia journal of public health, 6(1): 12–17.
5. Ma Y., Xiang Q., Yan C. et al. (2021) Relationship between chronic diseases and depression: the mediating effect of pain. BMC psychiatry, 21(1): 1–11.
6. Patel V., Chatterji S. (2015) Integrating mental health in care for noncommunicable diseases: an imperative for person-centered care. Health Affairs, 34(9): 1498–1505.
7. Alpert J.E., Papakostas G., Mischoulon D. et al. (2004) S-Adenosyl-L-Methionine (SAMe) as an Adjunct for Resistant Major Depressive Disorder. J. Clin. Psychopharmacol., 24(6): 661–664.
8. Bottiglieri T., Godfrey P., Flynn T. et al. (1990) Cerebrospinal fluid S-adenosylmethionine in depression and dementia: effects of treatment with parenteral and oral S-adenosylmethionine. J. Neurol. Neurosurg. Psychiatr., 53(12): 1096–1098. https://doi.org/10.1136/jnnp.53.12.1096.
9. Cuomo A., Beccarini Crescenzi B., Bolognesi S. et al. (2020) S-Adenosylmethionine (SAMe) in major depressive disorder (MDD): a clinician-oriented systematic review. Annals of general psychiatry, 19: 50. https://doi.org/10.1186/s12991-020-00298-z.
10. Textbook of Natural Medicine (2021). doi: 10.1016/c2015-0-02243-2.
11. Bottiglieri T. (2013) Folate, vitamin B₁₂, and S-adenosylmethionine. The Psychiatric clinics of North America, 36(1): 1–13. https://doi.org/10.1016/j.psc.2012.12.001.
12. Hamilton M. (1986) The Hamilton rating scale for depression. In Assessment of depression (pp. 143–152). Springer, Berlin, Heidelberg.
13. National Collaborating Centre for Mental Health (UK) (2010) Depression: the treatment and management of depression in adults (updated edition). British Psychological Society.
14. Gierk B., Kohlmann S., Kroenke K. et al. (2014) The somatic symptom scale-8 (SSS-8): a brief measure of somatic symptom burden. JAMA internal medicine, 174(3): 399–407.
15. Gray M., Monti K., Katz C. et al. (2021) A «Mental Health PPE» model of proactive mental health support for frontline health care workers during the COVID-19 pandemic. Psychiatry Research, 299: 113878.
16. Raman B., Cassar M.P., Tunnicliffe E.M. et al. (2021) Medium-term effects of SARS-CoV-2 infection on multiple vital organs, exercise capacity, cognition, quality of life and mental health, post-hospital discharge. Clin. Med., 31: 100683. doi:10.1016/j.eclinm.2020.100683.
17. Kanda Y. (2013) Investigation of the freely available easy-to-use software ‘EZR’for medical statistics. Bone marrow transplantation, 48(3): 452–458.
18. Assonov D. (2019) Cognitive impairment in patients with chronic noncommunicable diseases: a review. Psychosomatic medicine and general practice, 4(1).
19. Sarris J., Papakostas G.I., Vitolo O. et al. (2014) S-adenosyl methionine (SAMe) versus escitalopram and placebo in major depression RCT: efficacy and effects of histamine and carnitine as moderators of response. J. Affect. Dis., 164: 76–81. https://doi.org/10.1016/j.jad.2014.03.041.
20. Bell K.M., Potkin S.G., Carreon D., Plon L. (1994) S-adenosylmethionine blood levels in major depression: changes with drug treatment. Acta neurologica Scandinavica. Supplementum, 154: 15–18. https://doi.org/10.1111/j.1600-0404.1994.tb05404.x.
21. Bressa G.M. (1994) S-adenosyl-l-methionine (SAMe) as antidepressant: meta-analysis of clinical studies. Acta neurologica Scandinavica. Supplementum, 154: 7–14. https://doi.org/10.1111/j.1600-0404.1994.tb05403.x.
22. Fava M., Giannelli A., Rapisarda V. et al. (1995) Rapidity of onset of the antidepressant effect of parenteral S-adenosyl-L-methionine. Psych. Res., 56(3): 295–297. https://doi.org/10.1016/0165-1781(95)02656-h.
23. Khaustova O. (2017) Резистентна депресія: критерії визначення, фактори ризику і терапевтичні стратегії. Psychosom. Med. Gen. Pract., 2(3): e020338-e020338.
24. Бурчинський С.Г. (2021) Нейрометаболічна стратегія фармакотерапії афективних розладів: кому, коли і навіщо? Укр. мед. часопис, 1(141): 46–49.

Safety and efficacy of the Deprilium® complex in reducing subclinical symptoms of depression in patients with chronic non-communicable diseases: a double-blind, randomized controlled trial

References

Safety and efficacy of the Deprilium^® complex in reducing subclinical symptoms of depression in patients with chronic non-communicable diseases: a double-blind, randomized controlled trial