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Study Protocol and Statistical Analysis Plan

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Study Protocol and Statistical Analysis Plan / translated fom Russian into English using https://translate.google.com / Version from 03 October 2018 APPROVED BY Acting Director of NIIFM academician of RAS ___________________ L.I. Aftanas /signature, stamp/ Clinical trial subscription Title: "Evaluation of the efficacy and safety of Resveratrol in the treatment of depression: a double- blind, randomized, placebo-controlled study in two parallel groups of patients" ("Resveratrol") Principal investigators: academician of RAS Aftanas L.I., Danilenko K.V., MD responsible investigator: Markov A.A. RATIONALE In July 2015, the predominant involvement of the SIRT1 gene in the prevalence of depression in the Chinese population was revealed (CONVERGE, Nature, 2015). This gene mediates the activity of the sirtuin-1 protein, which is an antioxidant / cytoprotective enzyme (Kim et al., 2012). For the SIRT1 enzyme, a known activator is natural phytoalexin, a flavonoid-polyphenol resveratrol. Two-thirds of US residents who take dietary supplements (dietary supplements) in their food consume resveratrol-containing dietary supplements (Hubbard, Sinclair, 2014). The clinical effect of resveratrol is being studied in diabetes and obesity, cancer and cardiovascular diseases (www.clinicaltrials.gov). However, no studies have been conducted on the effects of resveratrol on depression (based on an analysis of the PubMed and www.clinicaltrials.gov databases). During the research, the dependence of the therapeutic effect on the structural features of the SIRT1 gene and its functional activity will be studied using the example of the sirtuin-1 enzyme. The structural features of the gene were studied in 2016-2017. within the framework of the Russian Science Foundation project No. 16-15-00128 "Structural features of the SIRT1 gene as a basis for the choice of personalized drug therapy for depression", which includes the Resveratrol study. In patients with MDD and dysthymia, the occurrence of the genotype in the rs2236318, rs7896005 and rs36107781 alleles of the SIRT1 gene was found to be statistically significantly different than in the population. At the same time, the safety of taking resveratrol will be monitored despite the fact that there is currently no information in the available literature on its side effects in humans. Resveratrol is metabolized by the liver by sulfation. In addition to resveratrol, active substances in the blood are its metabolites. The implementation of the study (in the version of the Study Description dated October 19, 2017) was approved by the Ethics Committee of NIIFFM (Protocol No. 13 dated October 27, 2017). The study was registered on December 19, 2017 in the Clinical Trials Registry at www.clinicaltrials.gov (NCT03384329) under the name "RESV-depression". The difference in HDRS-17 scores between the inclusion point and visit 2 is a key primary outcome measure. The difference in SIRT1 enzyme activity between the inclusion point and visit 2 is a key primary outcome measure, along with the change in HDRS-17 scores. The BDI-II score difference between the inclusion point and visit 2 is a secondary outcome measure. The study goal: To evaluate the efficacy and safety of resveratrol in the treatment of depression. 1 METHODS Patients The study is planned to be carried out from December 2017 to December 2018 on the basis of the NIIFFM (and, possibly, on the basis of the Tomsk NIIPZ - if patients are not recruited quickly enough). The target number of patients in the study is 60. Inclusion criteria: • men or women between the ages of 18 and 75; • body mass index (BMI) ≤30; • diagnosis of major depressive disorder (single episode or recurrent) with melancholic features or diagnosis of dysthymia (based on DSM-5 classification, Appendix 1); • current depression (according to DSM-5 criteria); • the severity of depression is moderate and higher according to the data of clinical examination and data of two scales: the Hamilton scale HDRS-17, completed by the physician-researcher (not less than 16 points), and the BDI-II scale, completed by the patient (not less than 20 points); • major depressive disorder or dysthymia significantly predominates in the clinical picture over other mental disorders that the patient may have (for example, personality disorder); • satisfactory and stable state of somatic health; if there are chronic diseases, then compensated, with a selected dose of constantly taken drugs; • the beginning of sleep – between 21:00–02:00; • the patient's consent to complete the entire study schedule; • signed informed consent to participate in the study. Non-inclusion criteria: • major depressive disorder with atypical features, anxious distress, with mixed features, with a seasonal pattern, with psychotic features (according to DSM-5 Appendix 1); • bipolar disorder; • resistant depression (lack of response to two consecutive treatments with therapeutic doses of antidepressants for at least 6 weeks each); • suicidal plans and intentions, aggressive behavior, psycho-productive symptoms; • antidepressant intake in the past: 3 weeks - fluoxetine, 2 weeks - non-selective MAO inhibitors, one week - other antidepressants (including herbal antidepressants); • taking normotimics and sleeping pills - in the last 2 weeks; • taking vitamins (especially nicotinamide) and dietary supplements - for the last week; • treatment with transcranial magnetic stimulation, current stimulation, xenon inhalation, light therapy, psychotherapy - in the last 2 weeks; • serious (severe) and / or unstabilized diseases: malignant neoplasms, uncontrolled arterial hypertension, stroke, epilepsy, tuberculosis, etc.; • pregnancy; • night work, crossing more than 2 time zones and an acute illness within the last week; • patient characteristics that prevent venipuncture; • patient refusal to undergo any research; • clinically significant pathological findings, conditions and circumstances that, in the opinion of the researcher, will negatively affect the patient's well-being, the course or results of the study. Exclusion criteria: • failure to conduct key examinations - assessing the severity of depression on the HDRS-17 scale and taking venous blood for the analysis of the activity of the SIRT1 enzyme - before and after the drug intake (inclusion visit and visit No. 2); • non-adherence to the drug - more than 3 days missed in any half of the study (15 days), admission at the wrong time (in the afternoon or evening instead of morning) most of the days; 2 • the appearance of moderate to severe adverse events (for example, (hypo) manic state) associated with, or probably associated with, taking the drug; • the emergence of non-compliance with the inclusion or non-inclusion criteria in the research process, including clinically significant pathological data, conditions and circumstances (for example, the loss of a loved one, etc.), which, in the opinion of the researcher, will negatively affect the patient's well-being, the course or results of the research. Randomization The study is a triple-blind, balanced, randomized study on two parallel groups of patients - taking resveratrol (30 people) and taking placebo (30 people). The medication comes from the manufacturer in two types of vials marked on the back: lot # 50743 (purple caps) or lot # 72005 (white caps). The information about which of them corresponds to the active substance, and which to placebo, is known only to the manufacturer, and will become known to researchers only after the completion of the entire study. Each bottle contains 60 capsules. The vials received from the manufacturer are kept in custody by the head of the pharmacy. From these vials, capsules in the amount of 30 pieces are transferred to other vials prepared in advance of the same type, each of which bears a sticker-label with the following information: (1) the name of the study - "Resveratrol", (2) the number of the vial - "1", "2", "3" ... (according to randomization codes). The list with randomization codes was prepared in advance by one of the study participants (K.V. Danilenko), known only to him and the head of the pharmacy, and is kept out of the reach of others (in a safe). The randomization is block, with a step of 2: each pair will contain 1 bottle of resveratrol and 1 bottle of placebo. The vials are held by the person in charge of randomization ("blinding") and dispensing of the drug (head of the pharmacy). he prepared vial with the active substance or placebo is issued by the head. pharmacy to the doctor- researcher for each individual patient. The dispensing of the vial is recorded in the Drug Dispensing Report Card (Appendix 3), which is held by the person responsible for the randomization (“blinding”) and dispensing of the drug (head of the pharmacy). At the time the bottle is dispensed, the patient's surname and initials, as well as his code, are applied to the bottle. The Table contains the following information: (1) vial number, (2) date of issue of the vial to the patient, (3) patient's surname and initials, (4) patient's date of birth, (5) patient code, (6) doctor's signature. Intervention Resveratrol. Resveratrol from Biotivia (USA), which is a dietary supplement (FDA). Each capsule contains: - 500 mg 98% trans-resveratrol (trans-resveratrol; polygonum cuspidatum root extract); - 5 mg 95% piperine (piperine; piper nigrum extract); - 5 mg 98% polydatin (polydatin; polygonum cuspidatum extract). The addition of piperine is due to the fact that this alkaloid increases the bioavailability of resveratrol (patent No. 5,536,506 dated July 16, 1996, USA; Johnson JJ et al., "Use of piperine to increase the bioavailability of nutritional compounds", 2011). All constituent ingredients are substances extracted from plants. This drug has already been used in clinical trials (eg in England; link). Microcrystalline cellulose (MCC) is used as a placebo capsule. Analytical control of resveratrol and piperine will be performed using preparative chromatography on an outsourced basis. The analysis will be performed for each delivered batch of capsules separately. The patient is given 30 capsules for a month. It is advisable for the patient to store capsules in the refrigerator at a temperature of +2 to + 8C, but it is also possible at room temperature.
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