Efficacy and safety of celecoxib for treatment of mild to moderate postpartum depression: a randomized, double-blind, placebo-controlled trial.

PURPOSE: Evidence has demonstrated the roles of inflammatory processes in pathogenesis of depression. We aim to assess the effects of adjunctive celecoxib with cognitive behavioral therapy (CBT), an anti-inflammatory agent, in treatment of postpartum depression and on levels of Brain-derived neurotrophic factor (BDNF) and inflammatory cytokines. METHODS: This was a randomized, double-blind, placebo-controlled trial to investigate the effects of adjunctive celecoxib with CBT on postpartum depression. Fifty outpatient women with postpartum depression, participated in this study. Patients randomly received either a celecoxib capsule twice a day or a placebo capsule twice a day for 6 weeks. Patients were assessed using the Hamilton Depression Rating Scale (HDRS) and the adverse event checklist at baseline and weeks 2, 4, and 6. RESULTS: Patients in the celecoxib group showed a greater decline in HDRS scores from baseline to all three study time points compared to the placebo group (p = 0.12 for week 2, p = 0.001 for week 4, p < 0.001 for week 6). Rate of response to treatment was significantly higher in the celecoxib group compared to the placebo group at week 4 (60 vs 24%, p = 0.010) and week 6 (96 vs 44%, p < 0.001). Rate of remission was significantly higher in the celecoxib group compared to the placebo group at week 4 (52 vs 20%, p = 0.018) and week 6 (96 vs 36%, p < 0.001). Levels of most inflammatory markers were significantly lower in the celecoxib group compared to the placebo group at week 6. Levels of BDNF were significantly higher in the celecoxib group compared to the placebo group at week 6 (p < 0.001). CONCLUSIONS: Findings suggest adjunctive celecoxib is an effective treatment for the improvement of postpartum depressive symptoms.

Vitamin E and ginseng supplementation to enhance female sexual function: a randomized, double-blind, placebo-controlled, clinical trial.

Female sexual disorders (FSD) are a spectrum of disorders common among women, especially in their middle age, which can reduce the female quality of life substantially. We aimed to evaluate the effects of a combined vitamin E and ginseng supplement on amelioration of female sexual dysfunction. In a 6-week, double-blind, randomized, placebo-controlled clinical trial, participants, suffering from sexual dysfunction based on the female sexual function index (FSFI) questionnaire, were randomly allocated to receive the supplement (100 IU vitamin E, 67 mg Korean ginseng, and 40 mg Siberian ginseng) or placebo daily. The primary outcome in our trial was the change in the FSFI total score. Sixty-nine participants were enrolled, but only 31 in each group completed the trial. Changes in the FSFI total score and its domain scores were significant during the trial course within each group. However, the supplement only ameliorated desire and satisfaction domains superior to the placebo. In case of the total score and other domains, the changes were insignificantly different between the treatment groups. Although our study could not find additional benefits for the vitamin E and ginseng supplement over placebo in enhancing sexual function overall, the supplement worked better in enhancing sexual desire and satisfaction.

Efficacy of Crocus sativus (saffron) in treatment of major depressive disorder associated with post-menopausal hot flashes: a double-blind, randomized, placebo-controlled trial.

PURPOSE: Due to concerns regarding the side effects of hormone therapy, many studies have focused on the development of non-hormonal agents for treatment of hot flashes. The aim of this study was to evaluate the efficacy and safety of saffron (stigma of Crocus sativus) in treatment of major depressive disorder associated with post-menopausal hot flashes. METHODS: Sixty women with post-menopausal hot flashes participated in this study. The patients randomly received either saffron (30 mg/day, 15 mg twice per day) or placebo for 6 weeks. The patients were assessed using the Hot Flash-Related Daily Interference Scale (HFRDIS), Hamilton Depression Rating Scale (HDRS) and the adverse event checklist at baseline and also at the second, fourth, and sixth weeks of the study. RESULTS: Fifty-six patients completed the trial. Baseline characteristics of the participants did not differ significantly between the two groups. General linear model repeated measures demonstrated significant effect for time × treatment interaction on the HFRDIS score [F (3, 162) = 10.41, p = 0.0001] and HDRS score [F (3, 162) = 5.48, p = 0.001]. Frequency of adverse events was not significantly different between the two groups. CONCLUSIONS: Results from this study revealed that saffron is a safe and effective treatment in improving hot flashes and depressive symptoms in post-menopausal healthy women. On the other hand, saffron, with fewer side effects, may provide a non-hormonal and alternative herbal medicine option in treatment of women with hot flashes.

The effects of pioglitazone adjuvant therapy on negative symptoms of patients with chronic schizophrenia: a double-blind and placebo-controlled trial.

OBJECTIVE: The evident central role of inflammation, oxidative stress, and metabolic derangement in pathophysiology of negative symptoms of schizophrenia has opened new insights into probable pharmacological options for these symptoms. Pioglitazone is an antidiabetic agent with anti-inflammatory and antioxidant properties. In this study, we evaluated the efficacy of pioglitazone as an adjunct to risperidone for reduction of negative symptoms in schizophrenia. METHODS: In this randomized, double-blind, placebo-controlled trial, 40 patients with chronic schizophrenia and a minimum score of 20 on the negative subscale of Positive and Negative Syndrome Scale (PANSS) were randomly allocated to receive risperidone plus either pioglitazone (30 mg/day) or placebo for 8 weeks. Patients' symptoms and adverse events were rated at baseline and weeks 2, 4, 6, and 8. The difference between the two groups in decline of PANSS negative subscale scores was considered as the primary outcome of this study. RESULTS: At the study endpoint, patients in the pioglitazone group showed significantly more improvement in PANSS negative subscale scores (p < 0.001) as well as PANSS total scores (p = 0.01) compared with the placebo group. CONCLUSION: These findings suggest the probable efficacy of pioglitazone as an augmentation therapy in reducing the negative symptoms of schizophrenia.

Minocycline combination therapy with fluvoxamine in moderate-to-severe obsessive-compulsive disorder: A placebo-controlled, double-blind, randomized trial.

AIM: Several lines of evidence implicate glutamatergic dysfunction in the pathophysiology of obsessive-compulsive disorder (OCD), presenting this neurotransmitter as a target for the development of novel pharmacotherapy. The objective of this study was to assess the efficacy of minocycline as an augmentative agent to fluvoxamine in the treatment of patients with OCD. METHODS: One hundred and two patients with the diagnosis of moderate-to-severe OCD were recruited to this study. A randomized double-blind trial was designed and patients received either L-carnosine or placebo as adjuvant to fluvoxamine for 10 weeks. The patients randomly received either minocycline 100 mg twice per day or placebo for 10 weeks. All patients received fluvoxamine (100 mg/day) for the first 4 weeks, followed by 200 mg/day for the rest of the trial, regardless of their treatment groups. Participants were evaluated using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS). The main outcome measure was to assess the efficacy of minocycline in improving the OCD symptoms. RESULTS: General linear model repeated measures demonstrated significant effect for time × treatment interaction on the Y-BOCS total scores, F(1.49, 137.93) = 7.1, P = 0.003, and Y-BOCS Obsession subscale score, F(1.54, 141.94) = 9.72, P = 0.001, and near significant effect for the Y-BOCS Compulsion subscale score, F(1.27, 117.47) = 2.92, P = 0.08. A significantly greater rate of partial and complete response was observed in the minocycline group (P < 0.001). The frequency of side-effects was not significantly different between the treatment arms. CONCLUSION: The results of this study suggest that minocycline could be a tolerable and effective adjuvant in the management of patients with OCD.

Effects of Antidepressant Medication on Brain-derived Neurotrophic Factor Concentration and Neuroplasticity in Depression: A Review of Preclinical and Clinical Studies.

Depression is the most prevalent and debilitating disease with great impact on societies. Evidence suggests Brain-Derived Neurotrophic Factor (BDNF) plays an important role in pathophysiology of depression. Depression is associated with altered synaptic plasticity and neurogenesis. BDNF is the main regulatory protein that affects neuronal plasticity in the hippocampus. A wealth of evidence shows decreased levels of BDNF in depressed patients. Important literature demonstrated that BDNF-TrkB signaling plays a key role in therapeutic action of antidepressants. Numerous studies have reported anti-depressant effects on serum/plasma levels of BDNF and neuroplasticity which may be related to improvement of depressive symptoms. Most of the evidence suggested increased levels of BDNF after antidepressant treatment. This review will summarize recent findings on the association between BDNF, neuroplasticity, and antidepressant response in depression. Also, we will review recent studies that evaluate the association between postpartum depression as a subtype of depression and BDNF levels in postpartum women.

Celecoxib in Treatment of Postpartum Depression: A Case Report.

Postpartum depression (PPD) impairs mother-infant interaction and has negative effects on the child's emotional, behavioral, and cognitive skills. There is considerable evidence to suggest that inflammation plays a role in the pathogenesis of depression. Controlled trials indicate that celecoxib has antidepressant effects in patients with major depressive disorder. A 34-year-old woman with mild to moderate PPD received a celecoxib capsule twice a day. This treatment has not been reported in previous studies and is novel in clinical practice. The patient was assessed using the Hamilton Depression Rating Scale (HDRS). Moreover, levels of brain-derived neurotrophic factor (BDNF) and inflammatory cytokines were measured at baseline and at the end of celecoxib therapy. This case suggests that celecoxib can improve depressive symptoms in patients with mild to moderate PPD. No adverse effects occurred during follow-up.

Crocus sativus (saffron) in the treatment of female sexual dysfunction: a three-center, double-blind, randomized, and placebo-controlled clinical trial.

Objective: One of the traditional aphrodisiacs used in various cultures is Crocus sativus, commonly called saffron. Previous studies have pointed to the possible applicability of saffron for sexual dysfunction in both men and women. This study investigates the effects of saffron capsules on female sexual dysfunction. Materials and Methods: This study was a parallel-group, double-blind, randomized, placebo-controlled clinical trial. Participants, who were married women between 18 and 55 years of age suffering from severe sexual dysfunction, were randomized to receive either 15 mg Crocus sativus capsules twice daily or placebo. The treatment continued for 6 weeks, and patients were evaluated every 2 weeks. The primary outcome was the change in the female sexual function index score. Other outcomes included the female sexual function index sub-domains. Results: Seventy -four patients were equally randomized to each group, and 34 in each group completed the trial. Participants in both groups experienced improved total scores at each visit. However, a repeated-measures ANOVA revealed that time treatment differed between groups in favor of the saffron group (p=0.050). During the 6th week follow-up, the saffron group had a 62% score improvement from baseline. Desire, lubrication, and satisfaction were female sexual function index domains in which saffron demonstrated superiority over placebo. The adverse event profile was similar for the groups, and no participant discontinued treatment. Conclusion: Findings of this study suggest that saffron might be a safe and effective option to ameliorate female sexual dysfunction. Further robust research is warranted.

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.

The effect of tactile-kinesthetic stimulation on growth indices of healthy neonates.

Therapeutic touch is emphasized by healthcare professionals for improvement of neonates' growth and development. However, inconsistencies exist regarding effects and methods of massage in neonates. The purpose of this clinical trial is to assess and comprise intervention and control groups regarding the effects of tactile-kinesthetic stimulation (TKS) by mothers on growth indices of healthy term neonates. Sixty healthy term neonates were randomly assigned into intervention and control groups. Mothers of neonates in the experimental group were trained to perform TKS for their newborns at home before feeding for at least 28 consecutive days, two times a day, and 15 min each time. Neonates in the control group were not required to receive this intervention. The neonates' growth indices were measured within 24 h after birth, and then at days 14 and 28. During the study and the three consecutive measurements, no significant difference was found between the mean weights, heights, and head circumferences of the neonates in the two groups (p > 0.05).

Comparison of Saffron and Fluvoxamine in the Treatment of Mild to Moderate Obsessive-Compulsive Disorder: A Double Blind Randomized Clinical Trial.

Objective: There are different pathophysiological mechanisms for obsessive- compulsive disorder (OCD) as suggested by the serotonergic, dopaminergic, and glutamatergic hypotheses. The present study aimed at comparing the efficacy and safety of saffron (stigma of Crocus sativus) and fluvoxamine in the treatment of mild to moderate obsessive- compulsive disorder. Method: In this study, 50 males and females, aged 18 to 60 years, with mild to moderate OCD, participated. The patients were randomly assigned to receive either saffron (30 mg/day, 15 mg twice a day) or fluvoxamine (100 mg/day) for 10 weeks. Using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) and the Adverse Event Checklist, we assessed the patients at baseline, and at the second, fourth, sixth, eighth, and tenth week. Finally, the data were analyzed using general linear repeated measures. Results: In this study, 46 patients completed the trial. General linear repeated measures demonstrated no significant effect for time-treatment interaction on the Y-BOCS total scores [F (2.42, 106.87) = 0.70, P = 0.52], obsession Y-BOCS subscale scores [F (2.47, 108.87) = 0.77, p = 0.49], and compulsion Y-BOCS subscale scores [F (2.18, 96.06) = 0.25, P = 0.79]. Frequency of adverse events was not significantly different between the 2 groups. Conclusion: Our findings suggest that saffron is as effective as fluvoxamine in the treatment of patients with mild to moderate OCD.

Trends of Mental Health Status in Iranian Population Aged 15 and above between 1999 and 2015.

INTRODUCTION: The main objective of this study was to compare the results of mental health surveys on adult populations of all provinces in Iran, between 1999 and 2015. METHODS: This study was an overview of two cross-sectional, descriptive studies that were performed in 1999 and 2015. The study population of these two studies consisted of urban and rural residents of all provinces in Iran. Samples were recruited by systematic random cluster sampling. In both studies, the General Health Questionnaire (GHQ-28) was used to assess mental health status of respondents. Trained psychologists completed questionnaires, and data were analyzed using SPSS software-18. RESULTS: The results showed that in the survey of 1999, 21% of participants suffered from mental disorders (25.9% of females and 14.9% of males). In the survey of 2015, 23.4% of samples were suspected of having mental disorders (27.6% of females and 19.3% of males). The prevalence of mental disorders increased from 1999 to 2014 by about 1.12 fold (1.06 fold in females and 1.3 fold in males). In the survey of 1999, rural residents were more at risk of mental disorders, while in the survey of 2015, urban residents were more prone to mental disorders. In both studies, the risk of suspicion for mental disorders increased with increasing age, and was higher in people aged 65 and above, as well as widowed, divorced and illiterate individuals. CONCLUSION: The results of this study showed an increase in suspected cases of mental disorders in Iran from 1999 to 2015. Therefore, it is vital for policymakers and health officials to take action in order to improve and maintain mental health status of the people who are at risk in the country.

Physical Activity Patterns in the Elderly Kashan Population.

BACKGROUND: Physical activity is an important component of health in old age that provides personal independence, physical ability, and quality of life. OBJECTIVES: The current study aimed to evaluate physical activity and associated factors among the elderly population in Kashan, Iran. PATIENTS AND METHODS: This is a descriptive cross-sectional study. The sample was 400 elderly people (aged more than 60 years) living in Kashan, Iran in 2014. The subjects randomly selected via multi-stage cluster sampling from healthcare centers in three regions of Kashan. The sample size differed by gender and residence type. Each participant's demographic characteristics and level of physical activity were recorded in a questionnaire, and the data were analyzed by SPSS version 16. Descriptive statistics, chi-square tests, Pearson correlations, and ordinal regression were used in the data analysis. The significance level for all the tests was P < 0.05. RESULTS: 237 (59.2%) of the subjects were female. The average age of the study population was 67.6 ± 6.8 years. Their average physical activity energy consumption was 326.21 ± 364.84 according to the metabolic equivalent of hours per week. 20 subjects (5%) reported no physical activity. 320 (80%) and 59 (14.8%) subjects had low and moderate physical activity levels, respectively. Only 1 subject (0.2%) had extreme levels of physical activity. Men (n = 43, 26.4%) were more likely to be moderately or extremely physically active than women were (n = 17, 7.2%). There was a significant relationship between physical activity and sex (P < 0.0001), marital status (P < 0.0001), educational status (P < 0.002), current occupation (P < 0.0001), and personal independence (P < 0.00001). Of course, effective predictive variations included age (P = 0.034), gender (P = 0.001), marital status (P = 0.033), independent status (P = 0), and local environment (P =0.001). CONCLUSIONS: The study revealed low physical activity in the elderly population in Kashan. The pattern of physical activity in the elderly depends on their lifestyle. A promotion of active lifestyles should be a part of health care planning for the elderly.