Effect of sertraline on depression severity and prolactin levels in women with polycystic ovary syndrome: a placebo-controlled randomized trial.

There is a paucity of data regarding the safety and efficacy of antidepressant therapy in women with polycystic ovary syndrome and depression. The effect of antidepressant medications on circulating prolactin levels is of concern in this patient population. We aimed to evaluate the effect of sertraline on depression severity and serum prolactin levels in women with polycystic ovary syndrome and mild-to-moderate depression. In a parallel-design, two-center, randomized controlled trial, we stratified participants according to their baseline prolactin level into normal (<25 ng/mL) and high (≥25 ng/mL) prolactin groups. Each group was randomized to receive 50 mg daily sertraline (up-titrated after 25 mg daily for 1 week) or placebo. The enrolling physicians, outcome assessors, and study subjects were all blind to the treatment. Depression severity was assessed by the Hamilton depression rating scale at baseline, the third, and the sixth weeks. The primary efficacy outcome was a change in depression severity. Prolactin levels were checked at baseline and after 6 weeks, and the safety outcome was the alteration in prolactin levels. Overall, 513 women were screened for eligibility in two outpatient clinics. Ultimately, 74 (38 normal prolactin and 36 high prolactin level) individuals were randomized. After 6 weeks of follow-up, depression severity was significantly reduced among patients who received sertraline regardless of the baseline prolactin levels (all between subjects P < 0.001). Furthermore, there was no difference in prolactin levels between the sertraline and placebo arms in normal (P = 0.80) or high prolactin (P = 0.21) groups. Sertraline is a well-tolerated and effective choice for treating depression in women with polycystic ovary syndrome. Future studies with longer follow-up periods are required to draw more robust conclusions.

Fluvoxamine combination therapy with tropisetron for obsessive-compulsive disorder patients: A placebo-controlled, randomized clinical trial.

BACKGROUND: About 50% of obsessive-compulsive disorder patients still suffer significant symptoms even after the recommended first-line therapy. This demonstrates the necessity to investigate strategies to improve alleviation of symptoms. OBJECTIVE: The main objective of this study was to investigate the efficacy of a 5-hydroxytryptophan 3 receptor antagonist, tropisetron, as an adjuvant therapy to selective serotonin reuptake inhibitors, in ameliorating obsessive-compulsive disorder symptoms. METHODS: Men and women between the ages of 18-60 years diagnosed with obsessive-compulsive disorder, based on DSM5, who had a Yale-Brown obsessive compulsive scale score of more than 21 were recruited in a double-blinded, parallel-group, placebo-controlled, clinical trial of 10 weeks to receive either tropisetron (5 mg twice daily) and fluvoxamine (100 mg daily initially followed by 200 mg daily after week 4) or placebo and fluvoxamine. The primary outcome of interest in this study was the Yale-Brown obsessive compulsive scale total score decrease from baseline. RESULTS: One hundred and eight participants were equally randomized into two groups; 48 participants in each group finished the trial. The Yale-Brown obsessive compulsive total score significantly dropped in both groups while the tropisetron group participants experienced a significantly higher decrease in their scores (Greenhouse-Geisser F(1.53-65.87)=3.516, p-value=0.04). No major adverse effect was observed in any of the groups. CONCLUSION: This trial showed a significant efficacy for tropisetron over placebo in treatment of obsessive-compulsive disorder symptoms when added to fluvoxamine.

Citicoline (CDP-choline) add-on therapy to risperidone for treatment of negative symptoms in patients with stable schizophrenia: A double-blind, randomized placebo-controlled trial.

OBJECTIVE: We aimed to evaluate the efficacy and tolerability of citicoline add-on therapy in treatment of negative symptoms in patients with stable schizophrenia. METHODS: In a double-blind and placebo-controlled study, patients with stable schizophrenia (DSM-5) were randomized to receive either 2,500 mg/day citicoline or placebo in addition to risperidone for 8 weeks. The patients were assessed using the positive and negative syndrome scale (PANSS), the extrapyramidal symptom rating scale (ESRS), and Hamilton depression rating scale (HDRS). The primary outcome was the difference in PANSS negative subscale score reduction from baseline to week 8 between the citicoline and the placebo groups. RESULTS: Sixty-six individuals (out of 73 enrolled) completed the trial. The citicoline group demonstrated significantly greater improvement in negative scores, F(1.840, 118.360) = 8.383, p = .001, as well as general psychopathology, F(1.219, 78.012) = 6.636, p = .008; change in general psychopathology did not remain significant after adjustment, and total PANSS scores, F(1.633, 104.487) = 15.400, p < .001, compared with the placebo. HDRS scores and its changes, ESRS score, and frequency of other side effects were not significantly different between the two groups. CONCLUSIONS: Citicoline add-on therapy to risperidone can effectively improve the primary negative symptoms of patients with schizophrenia.

L-carnosine as an add-on to risperidone for treatment of negative symptoms in patients with stable schizophrenia: A double-blind, randomized placebo-controlled trial.

Since l-carnosine has shown effectiveness in improvement of cognition in patients with schizophrenia, this 8-week, randomized, double-blind, placebo-controlled pilot study was conducted. Sixty-three patients with chronic schizophrenia, who were clinically stable on a stable dose of risperidone, entered the study. The patients were randomly assigned to l-carnosine (2 gr/day in two divided doses) or placebo for eight weeks. The patients were assessed using the positive and negative syndrome scale (PANSS), extrapyramidal symptom rating scale (ESRS), and Hamilton depression rating scale (HDRS) during the study course. Sixty patients completed the trial. L-carnosine resulted in greater improvement of negative scores as well as total PANSS scores but not positive subscale scores compared to placebo. HDRS scores and its changes did not differ between the two groups. Both groups demonstrated a constant ESRS score during the trial course. Frequency of other side effects was not significantly different between the two groups. In a multiple regression analysis model (controlled for positive, general psychopathology, depressive and extrapyramidal symptoms, as well as other variables), the treatment group significantly predicted changes in primary negative symptoms. In conclusion, l-carnosine add-on therapy can safely and effectively reduce the primary negative symptoms of patients with schizophrenia.

Palmitoylethanolamide as adjunctive therapy in major depressive disorder: A double-blind, randomized and placebo-controlled trial.

BACKGROUND: Experimental studies provide evidence for antidepressant effects of Palmitoylethanolamide (PEA) in animal models of depression. We aimed to evaluate the efficacy and tolerability of PEA add-on therapy in treatment of patients with major depressive disorder (MDD). METHODS: In a randomized double-blind, and placebo-controlled study, 58 patients with MDD (DSM-5) and Hamilton Depression Rating Scale (HAM-D) score ≥ 19 were randomized to receive either 600 mg twice daily Palmitoylethanolamide or placebo in addition to citalopram for six weeks. Patients were assessed using the HAM-D scale at baseline and weeks 2, 4, and 6. RESULTS: Fifty-four individuals completed the trial. At week 2, patients in the PEA group demonstrated significantly greater reduction in HAM-D scores compared to the placebo group (8.30 ± 2.41 vs. 5.81 ± 3.57, P = .004). The PEA group also demonstrated significantly greater improvement in depressive symptoms [F (3, 156) = 3.35, P = .021] compared to the placebo group throughout the trial period. The patients in the PEA group experienced more response rate (≥ 50% reduction in the HAM-D score) than the placebo group (100% vs. 74% respectively, P = .01) at the end of the trial. Baseline parameters and frequency of side effects were not significantly different between the two groups. LIMITATIONS: The population size in this study was small and the follow-up period was relatively short. CONCLUSIONS: Palmitoylethanolamide adjunctive therapy to citalopram can effectively improve symptoms of patients (predominantly male gender) with major depressive disorder. PEA showed rapid-onset antidepressant effects which need further investigation.

Management of Retinal Vein Occlusion, Who Is Responsible?

Retinal vein occlusion (RVO) is a common retinal vascular occlusive disorder and is associated with a variety of systemic risk factors. The aim of this study was to investigate whether the underlying diseases were evaluated and managed appropriately by ophthalmologists. We performed a study of 1344 patients with retinal vein occlusion (RVO). Patients were evaluated with a questionnaire including ten closed questions to determine whether ophthalmologists evaluated and informed their patients about the underlying systemic diseases. None of the patients' homocysteine levels were measured. Only a small percentage of the patients were asked about the history of thrombotic diseases or family history of thrombotic diseases. We believe that most ophthalmologists are still not entirely convinced of their responsibility of managing the underlying predisposing factors of RVO. Ophthalmologists should either manage or engage other healthcare providers in the management of RVO to guarantee the patient the best care.