Sertraline In Major Depressive Disorder Research Articles

L-theanine adjunct to sertraline for major depressive disorder: A randomized, double-blind, placebo-controlled clinical trial

BackgroundUnsatisfactory responses to major depressive disorder (MDD) therapeutics available necessitated up-to-date treatment approaches. This study sought to investigate the efficacy and tolerability of adjunctive l-theanine, a green tea constituent with neuropsychotropic effects, for MDD. MethodsSixty MDD (DSM-5) patients were equally assigned to receive sertraline (100 mg/d) plus either l-theanine (200 mg/d) or matched placebo in a six-week randomized, parallel-group, double-blind, placebo-controlled study. The participants were assessed using the Hamilton depression rating scale (HDRS) at baseline and weeks 2, 4, and 6. Changes in scores, early improvement, response and remission rates, and adverse events were compared between the groups. ResultsTwenty-five participants in each group, a total of 50 patients, completed the study. All baseline characteristics were similar between the groups. The general linear model repeated-measures analysis demonstrated a significant time-treatment interaction effect for HDRS during the trial (p-value = 0.014), indicating more remarkable symptom improvement in the l-theanine group. A greater reduction in HDRS scores was observed in the l-theanine group from baseline to weeks 2, 4, and 6 (p-values = 0.02, 0.03, and 0.01, respectively). All patients responded to sertraline plus l-theanine until week 6. l-theanine was superior to placebo regarding response to treatment and remission rates at week 6 (p-values = 0.05 and 0.02, respectively). The frequency of side effects was comparable between the groups. LimitationsThe small sample size and short study period were the limitations. Conclusionsl-theanine adjunct to sertraline outperforms placebo in treating MDD in a safe manner. Further long-term, large-scale studies are recommended to confirm this evidence.

Efficacy of Gemfibrozil as an Adjunct to Sertraline in Major Depressive Disorder, A Double-Blind, Randomized, and Placebo-Controlled Clinical Trial.

Objective: Major depressive disorder (MDD) is predicted to be one of the biggest disease burden in the future. The antidepressant activity of gemfibrozil has been recently considered. In this study, we assessed the effectiveness of gemfibrozil as a sertraline adjunct in treating patients with MDD. Method : In this study, 46 patients with MDD based on the DSM-V criteria with a minimum score of 22 on the 17-item Hamilton Rating Scale for Depression (HAM-D) were divided into two groups. One group was treated with 300 mg of gemfibrozil daily and the other group treated with placebo. Each group was treated simultaneously with 100 mg of sertraline daily for 8 weeks. The trial was randomized and double-blind. To assess the response to treatment, patients were evaluated at baseline and then at weeks 2, 4 and 8 using the HAM-D score. Results: The study was completed by 45 patients up to the final stages and follow-up visits. Repeated measure ANOVA with a Greenhouse-Geisser correction showed a significant difference for time×treatment interaction on within-subjects HAM-D scores [p–value= 0.026]. A notable difference was seen in time [p–value < 0.001]. The test of between-subject effects also represented a remarkable consequence of treatment on HAM-D scores at weeks 2, 4, and 8 [p–value = 0.07]. Using Kaplan-Meier estimate curves, time to remission periods were notable different between the 2 trial groups [Log-Rank p–value = 0.003]. Conclusion: Gemfibrozil is an effective adjunctive treatment in MDD and can be used to reduce depression symptoms.

Antidepressants effects of Rhodiola capsule combined with sertraline for major depressive disorder: A randomized double-blind placebo-controlled clinical trial

BackgroundWe performed a proof of concept trial to evaluate relative safety and efficacy of Rhodiola Capsule for mild to moderate major depressive disorder(MDD). MethodsIt is a randomized double-blind placebo-controlled clinical trial which 100 patients were randomized to 12 weeks into three groups. One of which (group A: 33 patients) received one sertraline and two placebos(0.6 g/day) tablets daily, a second (group B: 33 patients) received one sertraline and two Rhodiola capsules (0.6 g/day) daily, and a third (group C: 34 patients) received one sertraline,one placebo tablet and one tablet of Rhodiola capsule (0.3 g/day)daily. Changes over time in Hamilton Depression Rating (HAM-D), Beck Depression Inventory (BDI), and Clinical Global Impression Change (CGI/C) scores were examined. Significant post-treatment improvements were observed for both groups (Rhodiola Capsule) in HAMD, BDI, and CGI scores. The decline in HAMD, BDI, and CGI scores was greater for group B versus group A and C.While the CGI (versus group A) were greater for group B and C. ResultsStatistically significant reductions were observed for HAM-D, BDI, and CGI scores for all treatment conditions with significant difference between groups. The decline in HAM-D, BDI, and CGI scores was greater for group B versus group C and A. ConclusionsIt is concluded that the Rhodiola capsule shows anti-depressive potency in patients with depression disorder when administered in dosages of either 0.3 or 0.6 g/day over a 12-week period.Rhodiola capsule can improve the quality of life and clinical symptoms.The high doses of Rhodiola capsule are better than the lower doses.

Cerebral Blood Perfusion Moderates Treatment Response to Sertraline in Major Depressive Disorder

Cerebral Blood Perfusion Moderates Treatment Response to Sertraline in Major Depressive Disorder

Comparative efficacy of agomelatine versus sertraline in major depressive disorder in Himalayan region of India

Background: Depression, a major common affective disorder which carries excess mortality through suicide. Among various drug classes available SSRI’s are usually a choice, but many patients show inadequate response, residual symptoms or discontinue medication due to intolerable side effects. Disturbances of circadian rhythm function are an etiopathogenic hallmark of depression. The degree of circadian misalignment correlates with the severity of depression and circadian abnormalities may partially be a consequence of alterations in behavior and sleep patterns that accompany depression. Agomelatine an agonist acts on MT1 and MT2 receptors and antagonist of 5HT2c receptors contributes to its resynchronization of circadian rhythms, enhancement of dopaminergic and adrenergic input to the frontal cortex, induction of hippocampal neurogenesis, and ultimately, to its antidepressant effect.Methods: The study was randomized, prospective, comparative and interventional regarding the efficacy of therapy. Hundred consenting patients of MDD attending psychiatry OPD were screened for possible enrollment into group A(Agomelatine) and group B(Sertraline). Patients were assessed by semi-structured case recording form, DSM-IV- TR Criteria for major depressive episode, Hamilton Rating Scale for Depression (HAM-D) and Clinical Global Impressions for severity (CGI-S) at baseline and CGI for improvement (CGI-I), every two weeks interval and final assessment at 8 weeks.Results: Socio-demographic parameters like age and sex distribution, marital status, locality, family type, educational status, occupation and socio-economic class were comparable between two groups. Similarly baseline HAM-D and CGI-S values between the two groups were statistically non-significant. HAM-D, CGI-S and CGI-I values at eight weeks among the two groups were also statistically non-significant but in all three sertraline had decreased the values to a greater extent and showed a trend towards improvement.Conclusions: Both groups had shown significant decrease in scores of all scales i.e. HAM-D, CGI-S, and CGI-I at the end of 8th week as compared to baseline scores, indicating that the uses of agomelatine and sertraline have resulted in significant improvement in symptoms of patients of MDD and reinforcing there efficacy in treatment of MDD. No statistical difference was observed between two groups.

Journal Digest

Journal Digest

A Randomized Placebo Controlled Trial of Rhodiola Rosea and Sertraline for Major Depressive Disorder

A Randomized Placebo Controlled Trial of Rhodiola Rosea and Sertraline for Major Depressive Disorder

The impact of missing data on clinical trials: a re-analysis of a placebo controlled trial of Hypericum perforatum (St Johns wort) and sertraline in major depressive disorder.

Hypericum perforatum (St John's wort) is used to treat depression, but the effectiveness has not been established. Recent guidelines described the analysis of clinical trials with missing data, inspiring the reanalysis of this trial using proper missing data methods. The objective was to determine whether hypericum was superior to placebo in treating major depression. A placebo-controlled, randomized clinical trial was conducted for 8 weeks to determine the effectiveness of hypericum or sertraline in reducing depression, measured using the Hamilton depression scale.We performed sensitivity analyses under different assumptions about the missing data process. Three hundred forty participants were randomized, with 28 % lost to follow-up. The missing data mechanism was not missing completely at random. Under missing at random assumptions, some sensitivity analyses found no difference between either treatment armand placebo, while some sensitivity analyses found a significant difference from baseline to week 8 between sertraline and placebo (-1.28, 95 % credible interval [-2.48; -0.08]), but not between hypericum and placebo (0.56, [-0.64;1.76]). The results were similar when the missing data process was assumed to be missing not at random. There is no difference between hypericum and placebo, regardless of the assumption about the missing data process. There is a significant difference between sertraline and placebo with some statistical-methods used. It is important to conduct an analysis that takes account of missing data using valid statistically principled methods. The assumptions about the missing data process could influence the results.

A Case of Excessive Yawning With Citalopram

A Case of Excessive Yawning With Citalopram

Effectiveness and acceptability of sertraline and citalopram in major depressive disorder: pragmatic randomized open‐label comparison

Citalopram and sertraline are widely prescribed selective serotonin reuptake inhibitors (SSRIs). There is no conclusive evidence to show superiority of citalopram or sertraline in terms of efficacy or tolerability. Hence this study was designed to compare short term efficacy and safety of citalopram and sertraline in major depressive disorder (MDD) in Indian patients. In an open, randomized study, 100 patients were divided into two groups. In Group A (n = 50) patients received citalopram (20-60 mg/day) for 6 weeks. In Group B (n = 50) patients received sertraline (50-150 mg/day) for 6 weeks. Patients were evaluated at baseline and then at 1, 2, 3, 4, 5, and 6 weeks. There was significant improvement in Hamilton depression rating scale (HDRS), Montgomery and Asberg depression rating scale (MADRS) and Amritsar depressive inventory (ADI) scores (p < 0.05) with both the drugs. However, the decrease in score was more with citalopram (p < 0.05). Onset of action of citalopram was earlier as compared to sertraline (p < 0.05). The number of responders and remitters was also more with citalopram (p < 0.05). No serious adverse event was reported in either of the groups. Citalopram had shown better efficacy, earlier onset of action and more number of responders and remitters as compared to sertraline in MDD in Indian patients.

A placebo-controlled, randomized withdrawal study of sertraline for major depressive disorder in Japan

The objective of this double-blind, placebo-controlled, multicentre randomized withdrawal study was to evaluate the efficacy and tolerability of sertraline for 16 weeks in treating Japanese patients with major depressive disorder (MDD) who had achieved a response to 8 weeks of sertraline treatment. Patients (n=361) were initially treated with 8 weeks of open-label sertraline treatment followed by 16 weeks of double-blind treatment with either sertraline (50-100 mg/day) or placebo. Responders during the open-label phase were eligible to be entered into the double-blind phase. A total of 235 patients (65.1%) were entered to the double-blind phase and randomly assigned to receive sertraline (n=117) or placebo (n=118). A significantly (P=0.016) lower relapse rate was found for sertraline (8.5%) compared to placebo (19.5%) during the double-blind phase. Examination of time-to-relapse showed that the relapse free rate curve was significantly higher for sertraline (log-rank test, P=0.026) than placebo. Mean changes from beginning to end of the double-blind phase on measure of depressive symptoms, quality of life and global improvement also significantly favoured sertraline over placebo. Sertraline was well-tolerated, with similar adverse events as found in previous studies. These results confirm the efficacy of sertraline in preventing the relapse of MDD in Japanese patients.

99-6 - An open study of sertraline in major depressive disorder in children and adolescents

99-6 - An open study of sertraline in major depressive disorder in children and adolescents