Efficacy Of Sertraline Research Articles

A pooled analysis of the efficacy of sertraline in women, with a focus on those of childbearing age

IntroductionGender- and age-specific research on medications is essential for personalizing treatment plans, optimizing dosing, minimizing adverse effects and improving outcomes. Women are twice as likely to be diagnosed with major depressive disorder (MDD), and it is commonly reported during their reproductive years. This post-hoc pooled analysis evaluated the efficacy of sertraline (one of the most studied medications in women) in women of reproductive age (18–44 years).MethodsData was pooled from nine clinical trials of sertraline that included 1832 subjects with MDD. The analysis set included 1097 women, 651 of those were of reproductive age. Sertraline was compared with placebo for changes in total HAM-D17 and CGI scores measured over time through MMRM analysis. The change from baseline to the end of study (-week 8) was assessed using ANCOVA.ResultsThe changes from baseline in total HAM-D17 and CGI scores were significantly higher for sertraline than for placebo at the end of 8 weeks for all women (LS Mean difference, 95% CI: -1.81(-3.01,-0.62), P = 0.0029; -0.38(-0.55,-0.20), P < 0.0001, respectively). For women of reproductive age these changes (LS Mean difference, 95% CI: -2.08(-3.52,-0.64), P = 0.0047; -0.44(-0.66,-0.22), P < 0.0001, respectively), were significant from week 2 (HAM-D17) and week 1 (CGI) till the end of study.LimitationsOnly sertraline and placebo arms were included in the analysis. The dosing varied between studies, and the effect of dose was not addressed.ConclusionsSertraline is an effective option for treatment of MDD in women, including those in the childbearing age.

Safety and efficacy of sertraline in depression among adults undergoing dialysis: A systematic review and meta-analysis

Background: Depression is prevalent among patients with end-stage renal disease (ESRD) undergoing dialysis, with significant implications for their quality of life and treatment compliance. Traditional treatments for depression, including various therapies and pharmacological interventions, have limitations due to their adverse effects. Sertraline, a selective serotonin re-uptake inhibitor (SSRI), offers a promising alternative, but its efficacy and safety in this population require thorough evaluation. Objective: This meta-analysis aims to assess the effectiveness and adverse effects of sertraline in treating depressive episodes in dialysis patients compared to placebo. Methods: Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we conducted a comprehensive search of databases, including PubMed, Cochrane Library, and Science Direct, up to June 20, 2024. We included randomized controlled trials (RCTs) that compared sertraline with placebo in dialysis patients with depression. Two researchers independently performed data extraction and risk of bias assessment. Statistical analysis was conducted using ReviewManager 5.4.1, employing a random effects model. Results: Four RCTs involving 468 participants were included. Sertraline significantly reduced depressive symptoms, as measured by the Quick Inventory of Depressive Symptomatology (QIDS) and Beck Depression Inventory-II (BDI-II) scores, at 6 and 12 weeks compared to placebo. Improvements in kidney disease-specific quality of life (KDQOL-36) scores were also noted. However, sertraline was associated with a higher risk of adverse events compared to placebo. Conclusions: Sertraline effectively reduces depressive symptoms and improves the quality of life in dialysis patients with ESRD. Despite the increased risk of adverse events, the overall benefits make sertraline a viable treatment option for this population. Larger, more comprehensive studies are needed to confirm these findings and optimize sertraline use in clinical practice.

The preponderance of major depressive disorder among women of reproductive age and the clinical utility of sertraline

IntroductionMajor depressive disorder (MDD) is twice as common in women than men and is more frequently reported during their reproductive years (Shi et al. Front. Psychiatr 2021; 12 589687). MDD affects up to 12.7% of pregnant women and can significantly impact foetal and maternal health. Hence, clinical practice guidelines recommend focused screening and expedited management of MDD in women (Guo et al. Obstet. Gynecol 2018; 131(4) 671-679). Despite this, drug labelling or dosing recommendations rarely account for gender or physiological differences between sexes, even though sex steroid level variations can impact drug absorption, distribution, metabolism, and activity both pharmacokinetically and pharmacodynamically (Soldin et al. Clin Pharmacokinet. 2009; 48(3): 143–157). Sertraline, an SSRI approved for the treatment of MDD, is one of the safer agents which can be given to childbearing or breastfeeding women (Cuomo et al. Expert Opin Drug Saf 2018; 17(7) 719-725). However, studies on the efficacy of sertraline for the treatment of MDD among women of childbearing age are limited.ObjectivesThis post-hoc pooled analysis evaluated the efficacy of sertraline in women with MDD, with a particular focus on women of reproductive age.MethodsA pooled data analysis of 8 short-term clinical studies of sertraline in persons with MDD (comprising 1600 participants from North America and Europe, of whom 947 were females; with moderate to severe MDD [mean±SD baseline HAM-D17 score was 23.73±3.58 for sertraline and 23.37± 3.47 for placebo]; sertraline dose, 50-200 mg) was performed. HAM-D17 total score was used to assess the efficacy of sertraline compared with placebo. The study period was 8 weeks. An MMRM method was used to analyse changes over time and ANCOVA to evaluate the change from baseline at week 8 with LOCF employed to manage missing data.ResultsThe analysis set consisted of 947 women (sertraline, 612; placebo, 335). The change from baseline in HAM-D17 total score was significantly higher for sertraline than for placebo at the end of 8 weeks (LS mean difference, 95% CI: -1.81 [-3.01, -0.62], p=0.0029, Figure 1A). This change from baseline was statistically significant starting from week 2 and increased over time (Week 2-8; Figure 2A).The analysis set for women of child-bearing age consisted of 572 participants aged 18-44 (sertraline, 359; placebo, 213) from 7 clinical studies. The change from baseline in HAM-D17 total score was significantly higher for sertraline than for placebo at the end of 8 weeks (LS mean difference, 95% CI: -2.08 [-3.52, -0.64], p=0.0047, Figure 1B). This change from baseline was statistically significant starting from week 2 (Figure 2B).Image:Image 2:Conclusions Significant improvement in HAM-D17 scores was observed in the analysis, suggesting that sertraline is efficacious in treating women with MDD, including those in the childbearing age.Disclosure of InterestA. Fagiolini Grant / Research support from: Angelini, Boheringer Ingelheim, Janssen, Consultant of: Angelini, Biogen, Boheringer Ingelheim, Lundbeck, Janssen, Mylan, Neuraxpharm, Otsuka, Pfizer, Recordati, Rovi, Sanofi Aventis, Viatris, Speakers bureau of: Angelini, Apsen, Biogen, Boheringer Ingelheim, Glaxo Smith Kline, Lundbeck, Janssen, Mylan, Neuraxpharm, Otsuka, Pfizer, Recordati, Rovi, Sanofi Aventis, Viatris, Vifor, M. Mariano Consultant of: Johnson &amp; Johnson, Otsuka Pharmaceutical Inc., Speakers bureau of: Viatris Pharmaceuticals, Inc. Otsuka (Philippines) Pharmaceutical, Inc. H. Lundbeck A/S, Johnson &amp; Johnson Philippines, Inc., E. Biesheuvel Employee of: Viatris Inc. Netherlands, P. Purushottamahanti Employee of: Viatris Inc. India

Efficacy of Sertraline Combined with Agomelatine in the Treatment of Depression and its Influence on Cognitive Function

Efficacy of Sertraline Combined with Agomelatine in the Treatment of Depression and its Influence on Cognitive Function

The effect of mobile-based logotherapy on depression, suicidal ideation, and hopelessness in patients with major depressive disorder: a mixed-methods study

Major depressive disorder is one of the most common psychiatric disorders in the world. It is essential to study and use effective, available, and affordable psychotherapy methods along with drug therapy to manage the symptoms of this disease. Therefore, the current study aimed to determine the effect of mobile phone-based logotherapy on depression, suicidal ideation, and hopelessness in patients with major depressive disorder by using a mixed-methods approach. In the first phase of this mixed-methods study, 70 patients completed the quantitative phase (control group = 35, intervention group = 35). The intervention group received an 8-week mobile-based logotherapy program via WhatsApp (one 180-min module per week) combined with sertraline, while the control group received just sertraline plus education about pharmacotherapy. Data was collected before, immediately after the intervention, and 3 months later using the Beck depression inventory short form items (BDI-13), the Beck hopelessness scale (BHS), and the Beck scale for suicide ideation (BSSI). Then, a qualitative study on the intervention group was conducted to explain the findings of the quantitative phase. The repeated measure MANOVA revealed a significant interaction effect of time and group on the set of dependent variables (F(6,63) = 25.218, P < 0.001). Qualitative analysis confirmed the efficacy of sertraline plus mobile-based logotherapy on depression, suicidal ideation, and hopelessness in the intervention group. Three key themes extracted from the participants’ experiences of mobile-based logotherapy were “efficient instruction”, “user-friendly intervention” and “constructive change”. Mobile-based logotherapy through WhatsApp was an effective psychotherapy method for decreasing depression, hopelessness, and suicidal ideation in patients with major depressive disorder. It is suggested that educational, institutional, and technological infrastructure for providing and using mobile-based logotheapy for patients with major depressive disorder be considered in the mental health care system.

Effect of Sertraline on Serum Cytokine Levels in Adolescents With First-Episode Major Depressive Disorder

To investigate the changes in serum inflammatory cytokines and the predictive factors for the efficacy of sertraline following medication therapy in adolescents with first-episode major depressive disorder (MDD). A total of 61 adolescent patients with first-episode drug-naïve MDD were enrolled for the MDD group and 55 healthy adolescents were enrolled for the healthy control (HC) group. Sertraline tablets were administered to the MDD group for 8 weeks after enrollment, while no medication was given to the HC group. In the MDD group, blood samples were collected to measure the cytokine levels and clinical data, including scores for the 17-item Hamilton Depression Scale (HAMD-17) and the Connor-Davidson Resilience Scale (CD-RISC), were assessed at baseline and at the end of the 8-week medication, whereas in the HC group, blood samples and clinical data were collected only at baseline. The correlation between the levels of serum inflammatory cytokines and depression severity in the MDD group was analyzed and stepwise linear regression of HAMD-17 in the MDD group was performed to find serologic indicators that could be used to predict the efficacy of sertraline. At baseline, the levels of interleukin (IL)-1β and IL-6 in the MDD group were significantly higher than those in the HC group (all P<0.0001), while the tumor necrosis factor (TNF)-α level in the MDD group was significantly lower than that in the HC group ( P=0.006). After 8 weeks of medication treatment, the MDD group showed decreased levels of IL-1β and IL-6 and increased level of TNF-α compared to the pre-treatment levels. In addition, the HAMD-17 score, CD-RISC total score, and scores for perceived competence, trust and tolerance, and control, three factors of CD-RISC, all improved after treatment. There was no significant difference in serum cytokine levels at baseline between the subgroup showing response to the treatment and the non-responding subgroup. There was a weak correlation between IL-6 levels before and after treatment and CD-RISC scores and the scores for the trust and tolerance factor of CD-RISC before and after treatment. The baseline IL-1β and TNF-α levels did not show significant effect on posttreatment HAMD-17 scores. Serum cytokine levels of adolescents with first-episode MDD differ significantly from those of healthy adolescents. Although IL-6 was found to be correlated with depression severity, there was not enough support for it to be used as a predictor of the antidepression efficacy of sertraline.

Sertraline on Obsessive Compulsive Disorders in Indonesia (A Case Study)

Background: Obsessive-compulsive disorder (OCD) was originally believed to be a rare mental illness. However, recent surveys and research have shown that OCD is one of the most common mental disorders. Research in India showed that the treatment of OCD using SSRIs (selective serotonin reuptake inhibitors) is preferred over the tricyclic group. This paper will discuss sertraline as the alternative to clomipramine for OCD. Objective: Clomipramine as the treatment of choice for OCD is no longer included in the Indonesian MIMS index. Recent research suggests sertraline is preferred over clomipramine, and this paper discusses the efficacy of sertraline through a case study. Methods: This study is a retrospective descriptive study on the case of 21-year-old male met the ICD-X criteria of OCD for having unwanted thoughts and repetitive behavior for locking the door and orderly compiling the books. The symptoms developed since he graduated from high school (three years before admission) and got worse since the last year. Sertraline was prescribed in the first place. The patient was routinely monitored during each visit for the next three months. Results: The symptoms improved significantly after routinely taking sertraline for two months. The adverse effects were well-tolerated, such as nausea, headaches, and tachycardia. Psychotherapy was needed to modify the patient’s obsession and to anticipate the risk of personality disorder should be noticed because the disorder appeared at a young age. Conclusion: Sertraline as well as psychotherapy are worthy of consideration as first-line OCD therapy in Indonesia.

Efficacy of Sertraline with Aripiprazole versus Paroxetine with Aripiprazole in Patient with Major Depressive Disorder

Background: Major Depressive Disorder (MDD) is the most severe form of depression and can be extremely debilitating for those afflicted. Treatment for MDD typically involves the use of antidepressant medications such as selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). However, many patients do not respond adequately to these medications, leading to the use of adjunctive treatments, such as atypical antipsychotics. The combination of SSRIs and atypical antipsychotics has been found to be more effective than monotherapy with either medication alone. Aims: The Aim of this study is to compare the efficacy of two different combinations of antidepressants and atypical antipsychotics in the treatment of MDD: sertraline with aripiprazole, and paroxetine with aripiprazole. Study design and setting: Open-label trail. This study was conducted at Sir Cowasjee Jahangir Institute of Psychiatry &amp; Behavioral Sciences, Hyderabad, Pakistan from October 2021 to October 2022. Materials and Methods: In this research trial, a total of 48 patients were randomized to receive either sertraline (100 mg/day) plus aripiprazole (5 mg/day) or paroxetine (20 mg/day) plus aripiprazole (5 mg/day) for a period of 6 weeks. The outcome measure was assessed by the change in Hamilton Depression Rating Scale (HDRS) score from baseline to 6 weeks. Data was analyzed statistically using SPSS version 26. Results: The overall mean age of patients with MDD was 36.52 ± 9.9 years; 56% female and 46% male were reported with MDD. There was a significant reduction in HDRS scores among both groups of drugs; however, no difference was found in terms of efficacy between the two groups. Conclusion: The combination therapy of aripiprazole augmentation, with the addition of either sertraline or paroxetine, was equally effective in patients with Major Depressive Disorder. Keywords: Major depressive disorder, MDD, Sertraline, Paroxetine, Aripiprazole, Augmentation therapy.

Clinical value of penile sympathetic skin response to assess the efficacy of sertraline in the treatment of patients with sympathetic hyperexcitability in primary premature ejaculation.

The pathogenesis of primary premature ejaculation (PPE) is complex, and the pathologic basis may be an overactive sympathetic nervous system. To investigate sertraline efficacy in patients with sympathetic hyperexcitability in PPE and clarify the value of penile sympathetic skin response (PSSR) in assessing the efficacy of sertraline for PPE treatment. Sixty-three patients with PPE were recruited in the outpatient clinic and asked to take 50mg of oral sertraline daily for a 4-week treatment period. Changes in intravaginal ejaculation latency time (IELT), Premature Ejaculation Diagnostic Tool, International Index of Erectile Function (IIEF-5), and PSSR latency and wave amplitude were compared before and after treatment. The principal aim was to determine the relationships among sertraline efficacy, IELT, and PSSR latency and amplitude. After sertraline treatment, patients with PPE demonstrated a significant decrease in Premature Ejaculation Diagnostic Tool scores (P < .001); a significant increase in IELT, PSSR latency, and wave amplitude (P < .001); and no significant change in International Index of Erectile Function scores (P > .05). Moreover, the latency changes of PSSR were positively correlated with the increment of IELT (r = 0.550, P < .001). In addition, there was some degree of improvement vs pretreatment, although IELT and PSSR latencies were significantly shorter after drug discontinuation when compared with posttreatment (both P < .001). We aimed to find an objective test that accurately reflects the efficacy of treatment for sympathetic hyperexcitability in PPE. The strengths include a well-powered study, use of validated instruments, and self-assessment of treatment benefit. The limitations include the single-center design, relatively short-term follow-up, and lack of more comprehensive monitoring between treatment and drug discontinuation. These findings suggest that sertraline is effective for PPE treatment, that its efficacy can be partially maintained even after drug discontinuation, and that PSSR may be reliable for evaluating treatment success in patients with PPE.

Retracted: Efficacy of Sertraline Combined with Cognitive Behavioral Therapy for Adolescent Depression: A Systematic Review and Meta‐Analysis

Retracted: Efficacy of Sertraline Combined with Cognitive Behavioral Therapy for Adolescent Depression: A Systematic Review and Meta‐Analysis

Management of Psychiatric Disorders in Patients with Cardiovascular Diseases.

Management of Psychiatric Disorders in Patients with Cardiovascular Diseases.

Efficacy of Sertraline Combined with Cognitive Behavioral Therapy for Adolescent Depression: A Systematic Review and Meta-Analysis.

Objective The efficacy of antidepressant drugs combined with psychotherapy is controversial; hence, this meta-analysis was conducted to assess the efficacy of the combination therapy. Methods Relevant literature was searched in PubMed, Web of Science and Embase, Chinese databases CNKI, and WanFang Data. We included the literature on the comparison of the sertraline combined with cognitive behavioral therapy (CBT) and each treatment alone for adolescent depression published in 2000-2021. Meta-analysis was performed using Stata16.0 software. Results A total of 421 relevant articles were retrieved, and 14 studies were finally included. In comparison with the control group (sertraline), sertraline combined with CBT achieved higher response rate (OR = 5.07, 95% CI: 3.00, 8.58) and lower incidence of adverse reactions (OR = 0.43, 95% CI: 0.24, 0.75). Before treatment, there were no significant differences in depression score, anxiety score, and symptom self-rating scale score between the two groups. After treatment, depression score (SMD = −2.79, 95% CI: -3.64, -1.94), anxiety score (SMD = −1.22, 95% CI: -1.96, -0.47), and symptom self-rating scale score (SMD = −1.73, 95% CI: -3.19, -0.27) were significantly lower in the combined treatment group than in the control group. Conclusion Although the number of comparative trials is small, this study shows that sertraline is effective for adolescent depression, but sertraline combined with CBT is more effective. The latter can significantly reduce the incidence of depressive symptoms, anxiety, and adverse reactions in patients. Therefore, this combination therapy is recommended for the clinical treatment of adolescent depression.

Clinical efficacy of sertraline in the treatment of depression caused by Alzheimer disease: A protocol of systematic review.

Background:This study will appraise the clinical efficacy of sertraline in the treatment of depression caused by Alzheimer disease (AD).Methods:Comprehensive searches in PUBMED, EMBASE, Cochrane Library, Scopus, AMED, CNKI, and WANGFANG will be performed from inception to the present without language restriction. In addition, other sources will also be searched to avoid losing more potential studies. We will only consider randomized controlled trials that examined the efficacy of sertraline for depression in patients with AD. Two team members will independently undertake literature selection, data collection, and risk of bias assessment. We will use Cochrane Risk of Bias Tool to assess the risk of bias for each eligible trial, and will utilize RevMan 5.3 software to carry out data analysis.Results:This study will recapitulate high-quality evidence to assess the efficacy of sertraline for the treatment of depression following AD.Conclusion:The findings of this study will help to determine whether or not sertraline is effective for the treatment of depression after AD.OSF registration:osf.io/f29v6.

The Efficacy of Sertraline, Escitalopram, and Nicergoline in the Treatment of Depression and Apathy in Alzheimer's Disease: The Okayama Depression and Apathy Project (ODAP).

Neuropsychiatric symptoms of dementia such as depression and apathy in patients with Alzheimer's disease (AD) are associated with a lower quality of life. We aimed to determine the efficacy of two antidepressants and one antipathy drug in the treatment of depression and apathy in AD patients. In the present study, we evaluated the efficacy of sertraline (n = 11; average dose = 31.8 mg), escitalopram (n = 13; average dose = 7.3 mg), and nicergoline (n = 9; average dose = 14.5 mg) in treating depression and apathy over a period of 3 months (M).The 33 patients with AD demonstrated high Geriatric Depression Scale (GDS) (>5) or a high Apathy Scale (AS) (>16) scores. The patients receiving escitalopram treatment showed a significant improvement in GDS score from baseline (8.2±3.5) to 3 M (5.7±2.6, p = 0.04), and the patients receiving sertraline treatment showed a significant improvement in AS score from baseline (20.8±5.2) to 3 M (16.8±6.1, p = 0.05); however, no significant changes were noted in patients receiving nicergoline. These results provide novel information on the efficacy of sertraline and escitalopram in the treatment of apathy and depression, respectively, in patients with AD.

P1257SERTRALINE ADMINISTRATION TO PREVENT INTRADIALYTIC HYPOTENSION: A RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED, CROSSOVER STUDY (SLATAN STUDY)

Abstract Background and Aims Intradialytic hypotension (IDH) is the most common intradialytic complication ranging from 15-50% in chronic hemodialysis patients and increases morbidity and mortality in this population. According to pathophysiology, various strategies have been applied to treat this condition. Autonomic dysfunction is the one of the factors leading to IDH and is commonly found in elderly and diabetes patients. The use of sertraline to improve autonomic function was done in some small studies but the benefits was inconclusive, especially in diabetic patients. This study aimed to clarify an efficacy of sertraline regarding IDH in hemodialysis patients. Method We conducted a single-center, randomized, double-blinded, placebo-controlled, crossover study on chronic hemodialysis patient who had IDH in at least 25% of their dialysis sessions. Each patient received either sertraline or placebo for 4 weeks and were crossed to the other group after washout period for 4 weeks. Sertraline was started at the dose of 50 mg/day during the first week and was increased to 100 mg/day from week 2 to week 4. Matching placebo was adjusted using the same protocol as sertraline. The primary outcome was an incidence of IDH. Secondary outcomes included an incidence of IDH in subgroup of the patients with and without diabetes, the changes of blood pressure during hemodialysis session, and incidence of adverse events. Intention-to-treat analysis was applied to all data analyses. Results A total of 37 patients were enrolled into the study (48.6% males, mean age of 64.0±15.5 years, mean dialysis vintage of 2.4±2.4 years). All patients in sertraline group completed the study; however, 4 patients in placebo group dropped out due to adverse effects. Baseline characteristics did not differ between both groups. By analysis of crossover design, an incidence of IDH in sertraline group was significantly lower than placebo group (2.5±2.3 episodes versus 4.2±2.7 episodes during study period of 4 weeks, p for treatment effect &amp;lt;0.001, p for period effect = 0.802, and p for sequence effect = 0.811). In subgroup of diabetes patients, an incidence of IDH in sertraline group was 2.5±2.2 episodes versus 4.4±2.8 episodes in placebo group (p for treatment effect = 0.001, p for period effect = 0.491, and p for sequence effect = 0.382). However, there was no difference in incidence of IDH between the two groups in non-diabetes patients. There was no significant difference of adverse events between the two groups. Conclusion Among patients undergoing chronic hemodialysis with intradialytic hypotension, administration of sertraline significantly decreases intradialytic hypotension episodes. In addition, diabetes patients may confer more benefit from the treatment compared with non-diabetes status.

The Influence of Concentration of micro-RNA hsa-miR-370-3p and CYP2D6*4 on Equilibrium Concentration of Sertraline in Patients Diagnosed with Depressive Disorders Comorbid with Alcohol Use Disroder

Introduction: Sertralineis commonly administered topatients with depressive disorders comorbid with alcohol use disroder. Some part of such patients do not respond adequately to treatment regimen containing sertraline, whereas many of them experience type A adverse drug reactions (type A ADRs). Previous studies have shown that CYP2D6 is involved in the metabolism of sertraline, the activity of which is considerablydependent on the polymorphism of the gene encoding it. Objective: The objective of the study was to investigate the impact of 1846G>A polymorphism of the CYP2D6 gene on the concentration/dose indicator of sertralinepatients diagnosed with depressive disorders comorbid with alcoholism, using findings on activity of CYP2D6 (as evaluated by the 6M-THBC/pinoline ratio measurement) and on CYP2D6 expression level obtained by measuring the hsa-miR-370-3p plasma concentration levels patients suffering from depressive disorders comorbid with alcoholism. Material and Methods: The study included 120 patients with depressive disorders comorbid with alcoholism (age - 40.5±14.7 years). Therapy included sertraline in an average daily dose of 88.8±35.6 mg per day. Treatment efficacy was assessed using the validated psychometric scales. Therapy safety was assessed using the UKU Side-Effect Rating Scale. For genotyping and estimation of the microRNA (miRNA) plasma levels we performed the real-time polymerase chain reaction (PCR Real-time). The activity of CYP2D6 was assessed with HPLC-MS/MS method by the content of the endogenous substrate of given isoenzyme and its metabolite in urine (6M-THBC/pinoline). Theraputic drug monitoring (TDM) has been performed using HPLC-MS/MS. Results: Our study revealed the statistically significant results in terms of the treatment efficacy evaluation (HAMD scores at the end of the treatment course): (GG) 1.0 [1.0; 2.0] and (GA) 4.0 [3.0; 5.0], p < 0.001; at the same time, the statistical significance in the safety profile was obtained (the UKU scores): (GG) 3.0 [2.0; 3.0] and (GA) 3.0 [3.0; 3.0], p = 0.018. We didn't reveal a statistical significance for concentration/dose indicator of sertraline in patients with different genotypes: (GG) 0.749 [0.593; 1.277] and (GA) 1.030 [0.829; 1.257], p = 0.052). Analysis of the results of the pharmacotranscriptomic part of the study didn’t show the statistically significant difference in the hsa-miR-370-3p plasma levels in patients with different genotypes: (GG) 23.4 [16.3; 29.3], (GA) 26.1 [16.5; 28.9], p = 0.945. At the same time, correlation analysis didn't reveal a statistically significant relationship between the sertraline efficacy profile evaluated by changes in HAMD scale scores and the hsa-miR-370-3p plasma concentration: rs = -0.05, p = 0.592. Also, we didn't reveal the correlation between the miRNA concentration and safety profile: rs = 0.07, p = 0.421. Also we revealed the relationship between the CYP2D6 enzymatic activity (as evaluated by 6M-THBC/pinoline ratio measurement) and the hsa-miR-370-3p plasma concentration: rs = -0.25, p = 0.005. At the same time, correlation analysis revealed a statistically significant relationship between the sertraline concentration and the hsa-miR-370-3p plasma concentration: rs = 0.30, p < 0.001. Conclusion: Thus, the effect of genetic polymorphism of the CYP2D6 gene on the efficacy and safety profiles of sertraline was demonstrated in a group of 120 patients with depressive disorders comorbid with alcoholism. At the same time, hsa-miR-370-3p remains a promising biomarker for assessing the level of CYP2D6 expression, because it correlates with encoded isoenzyme activity. Funding Statement: This work was supported by the grant of the Russian Science Foundation (project No. 18- 75-10073). This work was financially supported by the project 16-15-00227 entitled “Fundamental research and exploratory research in priority areas of research” of the Russian Science Foundation. Declaration of Interests: The authors declare that there is no conflict of interest regarding the publication of this article. Ethics Approval Statement: The local ethical committee of the Russian Medical Academy of Continuous Professional Education of the Ministry of Health of the Russian Federation approved the research (The protocol No. 6 from 5/16/2017).

Lowered zinc and copper levels in drug-naïve patients with major depression: Effects of antidepressants, ketoprofen and immune activation

Objectives: The aim of the present work is to examine the effects of treatment with sertraline with and without ketoprofen on serum levels of zinc and copper in association with immune-inflammatory biomarkers in drug-naïve major depressed patients.Methods: We measured serum zinc and copper, interleukin (IL)-1β, IL-4, IL-6, IL-18, interferon-γ, and transforming growth factor-β1 in 40 controls and 133 depressed patients. The clinical efficacy of the treatment was measured using the Beck Depression Inventory-II (BDI-II) at baseline and 8 weeks later.Results: We found significantly reduced serum zinc and copper in association with upregulation of all cytokines, indicating activation of the immune-inflammatory responses system (IRS) and the compensatory immune regulatory system (CIRS). Treatment with sertraline significantly increased zinc and decreased copper. During treatment, there was a significant inverse association between serum zinc and immune activation. The improvement in the BDI-II during treatment was significantly associated with increments in serum zinc coupled with attenuation of the IRS/CIRS.Conclusions: Lower zinc is a hallmark of depression, while increments in serum zinc and attenuation of the immune-inflammatory response during treatment appear to play a role in the clinical efficacy of sertraline.

Efficacy of sertraline for post-stroke depression: A systematic review protocol of randomized controlled trial.

Background:Depression is a prevalent disorder for patients with stroke. Clinical researches indicate that sertraline is utilized to treat post-stroke depression (PSD) effectively. However, no systematic review has investigated this issue yet presently. Thus, this study aims to systematically assess the efficacy and safety of sertraline for patients with PSD.Methods:Literature sources will be divided into 2 sections: electronic sources and manual sources. We will search electronic literature sources as follows: EMBASE, MEDICINE, Web of Science, Cochrane Library, Allied and Complementary Medicine Database, Chinese Biomedical Literature Database, and China National Knowledge Infrastructure from their inceptions to the February 28, 2019. Manual sources include dissertations, ongoing trials, and conference abstracts. Two reviewers will select the literatures, extract and collect data information, and evaluate the risk of bias independently. Statistical analysis will be carried out by using RevMan 5.3 software.Results:Primary outcome is depression. It can be measured by Hamilton depression scale, Beck Depression Inventory, or any other scales. Secondary outcome are anxiety (as assessed by Hamilton anxiety scale, or other tools) response rate, activities of daily living (as measured by Barthel Index, or other scales), quality of life (as measured by 36-Item Short Form Health Survey), and safety.Conclusions:The results of this systematic review may summarize the up-to-date evidence on the efficacy and safety of sertraline for patients with PSD.Ethics and dissemination:This systematic review will not need any ethical approval, because it will not analyze any individual patient data. The findings of this study are expected to disseminate at peer-reviewed journals.

Comparison of the efficacy of sertraline combined with risperidone or quetiapine in the treatment of schizophrenia

Objective To compare the efficacy of sertraline hydrochloride combined with risperidone or quetiapine in the treatment of schizophrenia. Methods Eighty-six patients with schizophrenia in Ningbo Psychiatric Hospital were selected and divided into observation group and control group according to the order of admission.The observation group was treated with sertraline hydrochloride combined with quetiapine, and the control group was treated with sertraline hydrochloride combined with risperidone.The clinical symptoms score, clinical efficacy and adverse reactions were compared between the two groups. Results Before treatment, the negative symptoms, positive symptoms, psychopathology, total score between the two groups had no statistically significant differences(all P>0.05). After treatment, the negative symptoms, positive symptoms, psychopathology and total scores of the observation group were (13.43±1.27)points, (11.26±1.05)points, (13.54±1.84)points and(46.48±4.52)points, respectively, which were significantly lower than those of the control group[(16.87±1.98)points, (15.48±1.63)points, (18.35±2.04)points, (58.25±5.76)points](t=9.590, 14.272, 11.481, 10.541, all P 0.05). Conclusion Sertraline hydrochloride combined with quetiapine in the treatment of schizophrenia can improve the clinical symptoms of patients, the clinical efficacy is good, with mild adverse reactions. Key words: Schizophrenia; Risperidone; Quetiapine

A placebo controlled treatment trial of sertraline and interpersonal psychotherapy for postpartum depression

BackgroundThe purpose of the present study was to test the efficacy of sertraline and Interpersonal Psychotherapy (IPT) relative to pill placebo in a two site randomized controlled trial over a period of 12 weeks. It was hypothesized that sertraline and IPT would be more efficacious than pill placebo with respect to depression and social adjustment. Methods162 breastfeeding and non-breastfeeding women experiencing a major depressive episode in the first year postpartum from two sites in Iowa and Rhode Island were randomly assigned to IPT, sertraline-clinical management (CM), or pill placebo-CM. CM included infant-focused psychoeducation. Interview-based and self-report measures of depression and social adjustment were obtained at baseline, 4-weeks, 8-weeks, and 12-weeks of treatment. Linear mixed effects regression (LMER) was used for the longitudinal data analysis. ResultsThere was no significant effect for treatment condition associated with the primary outcome measure, the HamD-17, but there was a significant effect for sertraline-CM relative to the IPT and placebo conditions over the duration of the trial based on the General Depression scale of the Inventory of Depression and Anxiety Symptoms. There was a main effect for time in that study subjects across all three conditions showed significant improvement for the duration of the trial. LimitationsLimitations of the present study included significant non-engagement with assigned condition and differential effects of IPT across the two study sites. ConclusionsThere was improvement for all postpartum women in all conditions. The results do suggest that active interventions with or without medication delivered over a period of twelve weeks can lead to significant improvement in depression and social adjustment among postpartum women.ClinicalTrials.gov identifier: NCT00602355