L-Carnosine combination therapy for major depressive disorder: A randomized, double-blind, placebo-controlled trial

Background: Evidence for antidepressant effects of L-Carnosine was shown in some experimental studies. In this study we tried to evaluate the efficacy and tolerability of L-Carnosine combination therapy in treatment of patients with major depressive disorder (MDD). Methods: Fifty-eight patients with MDD (DSM-V) and Hamilton Depression Rating Scale (HAM-D) score � 19 were randomized to receive either 400 mg twice daily L-Carnosine or placebo in addition to citalopram (maximum dosage of 40 mg/day) for six weeks in a randomized double-blind, and placebo-controlled study. Patients were assessed using the HAM-D scale at baseline and weeks 2, 4, and 6. Results: Fifty-two patients completed the trial. General linear model repeated measure showed significant difference for time � treatment on HAM-D score F = 3.17, df = 2.39, p-value = 0.03. Significantly greater improvement was detected in HAM-D score of the L-Carnosine group compared with the placebo group from baseline to weeks 2, 4 and 6 Ps = 0.013, 0.028 and 0.023; respectively. Patients in the L-Carnosine group experienced significantly greater response and remission rate than the placebo group Ps = 0.023 and 0.012; respectively. There was no significant difference between the two groups in baseline parameters and frequency of side effects. Limitations: Short follow-up period and small population size were two important limitations of this study. Conclusions: L-Carnosine combination therapy with citalopram can effectively improve symptoms of patients with major depressive disorder. Rapid-onset antidepressant effects of L-Carnosine were also shown which need further investigation. © 2020 Elsevier B.V

Cinnamomum tamala as an adjuvant therapy in the treatment of major depressive disorder: A double-blind, randomized, placebo-controlled clinical trial with placebo control

Aim: Major depressive disorder (MDD) is one the most common diseases in the world and about one-third to one-half of the patients don't respond to routine treatment. Thus, the role of alternative medicines, like herbal drugs, is important. The aim of this present randomized, double-blind, placebo-controlled, 6-week trial was to assess the efficacy and tolerability of Cinnamomum tamala as an adjuvant to sertraline in treatment of patients with MDD. Methods: In a randomized double-blind clinical trial, 50 patients diagnosed with major depressive disorder (MDD) based on DSM V, were assigned into two parallel groups to receive sertraline (100 mg twice a day) plus placebo or sertraline (100 mg twice a day) plus Cinnamomum tamala (500 mg daily) for 6 weeks. Patients were evaluated for response to treatment using the HAM-D score at baseline and at weeks 2, 4 and 6. The main outcome measure was to assess the efficacy of C. tamala in improving the MDD symptoms. Results: Forty-two patients completed the trial. Repeated-measure analysis of variance showed a significant effect for time � treatment interaction (Greenhouse-Geisser corrected: F = 5.12, df = 2.19, p-value = 0.006) in HAM-D score. There was significant improvement in HAM-D score of the C. tamala group compared with the placebo group from baseline to weeks 2, 4 and 6. Ps = 0.012, 0.008 and 0.009; respectively. The frequency of adverse effects was similar between the two groups. Conclusion: The results of this study suggest that Cinnamomum tamala may be effective as an adjuvant agent in the treatment of MDD. © 2019 Elsevier Lt

5-Hydroxytryptophan as adjuvant therapy in treatment of moderate to severe obsessive-compulsive disorder: A double-blind randomized trial with placebo control

On the basis of numerous previous studies, the serotonergic system plays a role in the pathogenesis of obsessive-compulsive disorder (OCD) and effective agents in this pathway, such as 5-hydroxytryptophan, can potentially contribute to treatment of patients with this disorder. Evaluating the efficacy of 5-hydroxytryptophan in treating OCD was the aim of the present randomized, double-blind, placebo-controlled 12-week trial. In a 12-week, randomized double-blind study, 60 patients with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition diagnosis of moderate to severe OCD and a Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score of >21 were randomly assigned to receive either fluoxetine plus placebo or fluoxetine plus 5-hydroxytryptophan (100 mg twice daily). All patients, regardless of their treatment group, received fluoxetine at 20 mg/day for the initial 4 weeks of the study followed by 60 mg/day of fluoxetine for the rest of the trial course. Symptoms were assessed using the Y-BOCS at baseline and weeks 4, 8 and 12. General linear model repeated measure showed significant effects for time � treatment interaction on total Y-BOCS (F = 12.07, df = 2.29, P-value <0.001), obsession (F = 8.25, df = 1.91, P-value = 0.001) and compulsion subscale scores (F = 6.64, df = 2.01, P-value = 0.002). 5-Hydroxytryptophan augmentation therapy demonstrated higher partial and complete treatment response rate (P = 0.032 and P = 0.001, respectively) according to the Y-BOCS total scores. The results of this study confirm that 5-hydroxytryptophan may be effective as an augmentative agent in treatment of moderate-to-severe OCD. © 2020 Lippincott Williams and Wilkins. All rights reserved

Comparison of vortioxetine and sertraline for treatment of major depressive disorder in elderly patients: A double-blind randomized trial

What is known and objective: Major depressive disorder (MDD) is a complex disease and one of the leading contributors to disease burden throughout the world. In the current study, we explored the efficacy and tolerability of vortioxetine versus sertraline on symptoms of depression in elderly patients with MDD. Methods: Sixty patients diagnosed with MDD (based on DSM-5) and Hamilton Depression Rating Scale (HAM-D) score � 19 were entered into a randomized double-blind study and were randomized to receive either vortioxetine (15 mg daily) or sertraline (75 mg daily) for six weeks. Patients were assessed using the HAM-D scale at baseline and weeks 3 and 6. Changes in HAM-D score, response rates, remission rate and time to response or remission were also compared between the two study groups. Results and Discussion: Fifty patients completed the trial after six weeks. General linear model repeated measures demonstrated no difference in trend of the two treatment groups (P =.897). There was no significantly different improvement in the HDRS scores from baseline to weeks 3 and 6, as well. Differences in response rate, remission rate, time to response and time to remission periods were not statistically significant. Finally, there was not any significantly difference between the two study groups in the frequency of adverse events. What is new and conclusion: This study showed no significant differences in the efficacy and safety of vortioxetine in comparison with sertraline in order for it to be used safely for treatment of major depressive disorder in elderly patients. © 2020 John Wiley & Sons Lt