Polyprenols in the treatment of depression
Clinical study
6 persons suffering from depression took part in the study. They took the polyprenolic preparation for several months. A rapid decrease in depression symptoms was already observed in the first two weeks of the treatment, and the improvement only increased with the continuation of the treatment. After the treatment was completed, the patients were controlled for 2 to 4 months more: the remission persisted in 5 of 6 patients during that period, no return of the depression was observed.
V. S. Sultanov, E. D. Schastny Solagran Ltd. (Australia), Research Institute of Mental Health of the Siberian Branch of the Russian Academy of Medical Sciences (Tomsk, Russia) Evgenii Dmitrievich Schastny, Research Institute of Mental Health of the Siberian Branch of the Russian Academy of Medical Sciences, +7 3822 792439, schastnyy@mail.tomsknet.ru
Affective disorders are a multifactorial pathology with the proven neurobiological basis: membrane equilibrium in cells is broken in cases of depression, and a hypothesis is advanced of the interrelation of these disorders with a membrane structure defect. Great attention is paid to metabolites of isoprenoid exchange in the body in cases of different mental diseases in clinical practice. The polyprenolic preparation* contains exogenous polyprenols that are natural bioregulators of many metabolically important processes.
The study was conducted in the department of affective states of Research Institute of Mental Health of the Siberian Branch of the Russian Academy of Medical Sciences in 2010. A group for the clinical tests with polyprenols* was composed of 6 ambulatory patients drawn at random (2 men, 4 women). The average age by the beginning of the treatment was 51.0 ± 10.39 years (men − 57.0 ± 4.24 years, women − 48.01 ± 1.25 years). The nosologic characteristic was represented as follows: a one-time depressive episode − 1 person, recurrent depressive disorder, a current depressive episode of mild/moderate degree − 5 patients.
The average duration of the current depressive episode was 4.17 ± 2.32 months. All patients were assigned the polyprenolic preparation* within the first two weeks of administration in the dose of 3 drops 3 times a day. The dose was increased to 4 drops 3 times a day on the 14th day. In the case of dynamics, the dose was increased to 4 drops three times a day on the 14th day of therapy and to 6 drops a day on the 28th day, which remained unchanged till the end of the study. The criterion of effectiveness of the therapy with polyprenols* was the reduction of the initial score of the Montgomery-Asberg depression rating scale (MADRS) by more than 50% of the original, as well as the score of the scale of clinical global impression (CGI) on the item of CG 1-severity and on the item of CGI-improvement. Adverse effects (AE) of the preparation were assessed with the side effect rating scale (UKU).
According to the total score of MADRS, the curve of the therapeutic response to the increasing dose of polyprenols* differs from the similar indicators of the selective serotonin-reuptake inhibitor (SSRI) therapy. The average depth of depression before treatment was 18.33 ± 3.20 points in the group of patients treated with polyprenols*. A statistically significant reduction in the level of depression was found. In the end of the treatment, the number of points was 2.67±2.50 (р < 0.001). Depressive symptoms quickly reduced within the first two weeks of the therapy, the number of points dropped by the end of the second week to 9.50±2.74 and to 4.67±2.34 points by the end of the fourth week of the therapy in the study group (р < 0.01). The scale of the clinical global impression from the start of the therapy and by the time of completion of the study in the group had 3.5±0.55 and 1.5±0.84 points, respectively. A "significant" improvement on the 14th day of the therapy was revealed in 100.0% of cases. It was required to increase the dose of the polyprenolic preparation* for one patient with moderately severe depression on the 3rd day of the therapy due to increased insomnia. AE (heartburn and nausea) were observed in 2 patients within one week, with the dose of the preparation of 6 drops, in one patient this AE ceased independently, and in the other patient – with the reduction of the dose to 4 drops. The catamnesis after completion of the study ranged from 2 to 4 months: clinical remission persisted in 5 of 6 patients, which makes us assess the potential of the anti-relapse action of the polyprenolic preparation* in a new way.
* A polyprenolic preparation of Ropren was used the study, which is a pure concentrate of polyprenols (the total fraction is 95%). The text of the study is provided by courtesy of Solagran.