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.

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.

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.

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.

Crocus sativus L. Versus Methylphenidate in Treatment of Children with Attention-Deficit/Hyperactivity Disorder: A Randomized, Double-Blind Pilot Study.

OBJECTIVE: Attention-deficit/hyperactivity disorder (ADHD) is one of the most common neuropsychiatric disorders of childhood and adolescence. About 30% of patients do not respond to stimulants or cannot tolerate their side effects. Thus, alternative medication, like herbal medicine, should be considered. The aim of this trial is to compare the safety and efficacy of Crocus sativus (saffron) versus methylphenidate in improving symptoms of children with ADHD. METHODS: In a 6-week randomized double-blind study, 54 patients (children 6-17 years old) with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of ADHD were randomly assigned to receive either 20-30 mg/d (20 mg/d for <30 kg and 30 mg/d for >30 kg) methylphenidate (MPH) or 20-30 mg/d saffron capsules depending on weight (20 mg/d for <30 kg and 30 mg/d for >30 kg). Symptoms were assessed using the Teacher and Parent Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) at baseline and weeks 3 and 6. RESULTS: Fifty patients completed the trial. General linear model repeated measures showed no significant difference between the two groups on Parent and Teacher Rating Scale scores (F = 0.749, df = 1.317, p = 0.425, and F = 0.249, df = 1.410, p = 0.701, respectively). Changes in Teacher and Parent ADHD Rating Scale scores from baseline to the study end were not significantly different between the saffron group and the MPH group (p = 0.731 and p = 0.883, respectively). The frequency of adverse effects was similar between saffron and MPH groups. CONCLUSION: Short-term therapy with saffron capsule showed the same efficacy compared with methylphenidate. Nevertheless, larger controlled studies with longer treatment periods are necessary for future studies.

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

AIM: The role of the glutamatergic system in the pathogenesis of obsessive-compulsive disorder (OCD) has been shown by numerous studies. The aim of the present randomized, double-blind, placebo-controlled, 12-week trial was to assess the efficacy and tolerability of amantadine as an adjuvant to fluvoxamine in the treatment of patients with moderate to severe OCD. METHODS: One hundred patients diagnosed with moderate to severe OCD were randomized into two parallel groups to receive fluvoxamine (100 mg twice a day) plus placebo or fluvoxamine (100 mg twice a day) plus amantadine (100 mg daily) for 12 weeks. All patients received 100 mg/day fluvoxamine for 28 days followed by 200 mg/day for the rest of the trial, regardless of their treatment groups. Patients were evaluated for response to treatment using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) at baseline and at Weeks 4, 10, and 12. The main outcome measure was to assess the efficacy of amantadine in improving the OCD symptoms. RESULTS: Repeated-measure analysis of variance showed a significant effect for Time × Treatment interaction (Greenhouse-Geisser corrected: F = 3.84, d.f. = 1.50, P = 0.03) in the Y-BOCS total score and a significant effect for Time × Treatment interaction (Greenhouse-Geisser corrected: F = 5.67, d.f. = 1.48, P < 0.01) in the Y-BOCS Obsession subscale score between the two groups. CONCLUSION: The results of this study suggest that amantadine may be effective as an augmentative agent in the treatment of moderate-to-severe OCD.