Levetiracetam as an Adjunctive Treatment for Mania: A Double-Blind, Randomized, Placebo-Controlled Trial.

BACKGROUND: Levetiracetam is an anticonvulsant with a low side effect profile and favorable properties for individuals with bipolar I disorder during their manic phase. Despite initial promising results until about 2008, it appears that this track of research has not been followed-up. To counter this, we tested the influence of adjuvant levetiracetam on acute mania, compared to placebo. More specifically, we performed a randomized, double-blind, placebo-controlled clinical trial among inpatients with bipolar disorder I during their acute phase of mania. METHODS: A total of 72 inpatients (mean age: 33.98 years; 23.6% females) with diagnosed bipolar disorder I and during their acute manic phase were randomly assigned either to the adjuvant levetiracetam (250 mg to a maximum of 1,500 mg) or to the placebo condition. Standard medication was lithium at therapeutic dosages. At baseline, participants completed a series of self-rating questionnaires covering sociodemographic information and subjective sleep. Subjective sleep was re-assessed 24 days later at the end of the study. Experts rated participants' acute state of mania with the Young Mania Rating Scale at baseline and at day 12 and day 24. Participants' cognitive performance was assessed at baseline and at day 24 at the end of the study. RESULTS: Over time, mania scores significantly decreased (large effect size), but more so in the levetiracetam condition, compared to the placebo condition (medium effect size). Likewise, over time, subjective sleep improved (large effect size), but more so in the levetiracetam condition, compared to the placebo condition (large effect size). Over time, cognitive performance improved (large effect size), irrespective of the study condition. CONCLUSIONS: Compared to placebo, adjuvant levetiracetam to lithium improved symptoms of mania, as rated by experts, and subjective sleep quality. Adjuvant levetiracetam had no further favorable (or detrimental) impact on cognitive performance.

Influence of Simvastatin as Augmentative Therapy in the Treatment of Generalized Anxiety Disorder: A Pilot Randomized, Placebo-Controlled Study.

BACKGROUND: Preliminary evidence is promising regarding the anxiolytic effects of statins in animal models of anxiety. Hence, this study aimed to evaluate the efficacy of simvastatin augmentation versus placebo in the treatment of patients with generalized anxiety disorder (GAD) with residual symptoms despite treatment with selective serotonin reuptake inhibitors (SSRIs). METHODS: A double-blind, 8-week controlled trial was conducted from August 2018 to December 2019 in an outpatient psychiatry clinic in Hamadan, Iran. A total of 138 patients with a diagnosis of GAD were assessed for eligibility. Of them, 84 patients who met the study criteria were randomly assigned either to the adjuvant simvastatin (20 mg/day) or to the placebo group. Standard medication consisting of SSRIs was consistent 2 months prior to and during the study. The severity of anxiety symptoms for each patient was assessed based on the Hamilton Anxiety Rating Scale (HAM-A) score at baseline, week 4, and week 8 after treatment. Additionally, blood lipid values were assessed at baseline and on completion of the study. RESULTS: Thirty-three out of 42 patients in the intervention group and 35 out of 42 patients in the control group completed the 8 weeks of the study period. Compared to the placebo group, in the simvastatin group cholesterol, triglycerides, and low-density lipoprotein significantly decreased, and high-density lipoprotein significantly increased over time. General linear model analysis demonstrated that although over time a higher decrease in mean HAM-A scores was observed in the intervention group compared to the control group, this difference was not statistically significant (p = 0.11). In addition, at the end of the study, the number of responders and remitters was comparable in the two groups. CONCLUSIONS: The results from this clinical study did not support the potential efficacy of adjunctive simvastatin in the treatment of patients with GAD. Thus, large-scale and long-term clinical trials are required to more accurately assess the potential efficacy of statins in the treatment of patients with anxiety disorders.

Effect of Rivastigmine (Acetyl Cholinesterase Inhibitor) versus Placebo on Manic Episodes in Patients with Bipolar Disorders: Results from a Double Blind, Randomized, Placebo-Controlled Clinical Trial.

BACKGROUND: To treat patients with bipolar disorders (BPD) during the acute phase, the standard procedure is to administer lithium or sodium valproate. To further optimize treatment, acetylcholinesterase inhibitors such as donepezil and galantamine have gained increased interest, though with conflicting results. In the present randomized, double-blind, placebo-controlled clinical trial, we investigated whether, and to what extent, adjuvant rivastigmine might improve symptoms of mania in patients with BPD during the acute manic phase. METHODS: A total of 70 patients with BPD in an acute state of mania (mean age 33.8 years; 24% females) took part in this study. After a thorough clinical interview, standard treatment consisted of 20mg/kg/day of sodium valproate; next, patients were randomly assigned either to the adjuvant rivastigmine or to the placebo condition. The study duration was 24 days. The dose of rivastigmine was 1.5 mg for the first 7 days and 3 mg from day 8 to day 24. Experts blind to the patients' study condition rated patients' mania scores, symptom severity, and symptom improvements at baseline (except symptom improvements) and 4, 8, 12, and 24 days after the beginning of this study. RESULTS: Symptoms of mania improved over time, but more so in the adjuvant rivastigmine compared to the placebo condition. Greater improvements were observed from day 8 on. CONCLUSIONS: The pattern of results from the present randomized, placebo-controlled, double-blind study suggests that adjuvant rivastigmine, a cholinesterase inhibitor, improved symptoms of mania among a larger sample of inpatients with BPD and in the acute manic state. However, the improvements were modest, and the results should be replicated and above all balanced against side effects.

Influence of adjuvant Coenzyme Q10 on inflammatory and oxidative stress biomarkers in patients with bipolar disorders during the depressive episode.

Bipolar disorder (BPD) is a severe and chronic mental disease with high rates of social and functional disability. To explain the emergence and maintenance of BPD, increasing attention has been focused on dimensions of inflammation and oxidative stress (OTS). Coenzyme Q10 (CoQ10) is known for its anti-oxidant and anti-inflammatory effects; accordingly, the aim of the present study was to investigate, if compared to placebo, adjuvant CoQ10 might favorably impact on serum levels of inflammatory and OTS biomarkers in patients with BPD during their depressive phase. A total of 89 BPD patients, currently in a depressive episode were allocated by block randomization either to the adjuvant CoQ10 (200 mg/day) condition or to the placebo condition. At baseline and 8 weeks later at the end of the study, serum levels of total antioxidant capacity (TAC), total thiol groups (TTG), catalase activity (CAT), nitric oxide (NO), malondialdehyde (MDA), tumor necrosis factor-alpha (TNF-α), interlukin-6 (IL-6), and IL-10 were assessed. 69 patients completed the 8-week lasting study. Compared to baseline and to the placebo condition, serum levels of TTG and TAC significantly increased, and TNF-α, IL-10, and NO statistically decreased over time in the adjuvant CoQ10 condition. No statistically significant changes were observed for CAT, MDA, and IL-6. The pattern of results suggests that compared to placebo and over a time lapse of 8 weeks, adjuvant CoQ10 favorably impacted on OTS and inflammatory biomarkers in patients with BPD during the depressive episode. Thus, CoQ10 might be considered a safe and effective strategy for treatment of patients with BPD during their depressive phase.

Evaluating the Effect of Coenzyme Q10 Augmentation on Treatment of Bipolar Depression: A Double-Blind Controlled Clinical Trial.

BACKGROUND: Bipolar disorder (BPD) is a chronic and recurrent mood disorder characterized by episodes of mania, hypomania, and major depression. Based on available evidence, mitochondrial dysfunction, oxidative stress, and inflammation have important roles in the pathophysiology of bipolar depression. More specifically, it seems that coenzyme Q10 (CoQ10), a mitochondrial modulator, as well as an antioxidant and anti-inflammatory agent, might be effective in modulating these pathophysiological pathways. Accordingly, the aim of this study was to investigate whether and to what extent, compared with placebo, adjuvant CoQ10 might improve symptoms of depression in patients with BPD. METHODS: A total of 69 patients with BPD with a current depressive episode were randomly assigned either to the adjuvant CoQ10 (200 mg/d) or to the placebo group. Standard medication consisting of mood stabilizers and antidepressants was consistent 2 months prior and during the study. Depression severity for each patient was assessed based on the Montgomery-Asberg Depression Rating Scale scores at baseline, fourth week, and eighth week of the study. RESULTS: Symptoms of depression decreased over time in both groups. Compared with the placebo group, adjuvant CoQ10 to a standard medication improved symptoms of depression after 8 weeks of treatment. In addition, at the end of the study, it turned out that more responders were observed in the CoQ10 group, compared with the placebo group. CoQ10 had minimal adverse effects and was well tolerated. CONCLUSIONS: The present pattern of results suggests that among patients with BPD, compared with placebo, adjuvant CoQ10 probably because of its antioxidant and anti-inflammatory properties can improve symptoms of depression over a period of 8 weeks.

Influence of adjuvant detached mindfulness and stress management training compared to pharmacologic treatment in primiparae with postpartum depression.

Ten to 15% of mothers experience postpartum depression (PPD). If untreated, PPD may negatively affect mothers' and infants' mental health in the long term. Accordingly, effective treatments are required. In the present study, we investigated the effect of detached mindfulness (DM) and stress management training (SMT) as adjuvants, compared to pharmacologic treatment only, on symptoms of depression in women with PPD. Forty-five primiparae (mean age: M = 24.5 years) with diagnosed PPD and treated with an SSRI (citalopram; CIT) took part in the study. At baseline, they completed questionnaires covering socio-demographic data and symptoms of depression. Experts rated also symptoms of depression. Next, participants were randomly assigned to one of the following study conditions: adjuvant detached mindfulness (CIT+DM); adjuvant stress management training (CIT+SMT); control condition (CIT). Self- and experts' ratings were completed at the end of the study 8 weeks later, and again at 8 weeks follow-up. Symptoms of depression decreased significantly over time, but more so in the CIT+DM and CIT+SMT group, compared to the control condition. The pattern of results remained stable at follow-up. In primiparae with PPD and treated with a standard SSRI, adjuvant psychotherapeutic interventions led to significant and longer-lasting improvements.

Early maladaptive schemas of emotional deprivation, social isolation, shame and abandonment are related to a history of suicide attempts among patients with major depressive disorders.

BACKGROUND: Patients with psychiatric disorders have an exceptionally high risk of completed or attempted suicide. This holds particularly true for patients with major depressive disorders. The aim of the present study was to explore whether patients with major depressive disorders (MDD) and a history of suicide attempts differed in their early maladaptive schemas from patients with MDD but without such a history or from healthy controls. METHOD: Ninety participants took part in the study. Of these, 30 were patients with MDD who had made a recent suicide attempt; 30 were patients with MDD but no suicide attempts, and 30 were gender- and age-matched healthy controls. Participants completed questionnaires covering socio-demographic characteristics and the Young Schema Questionnaire (YSQ- RE2R) to assess early maladaptive schemas. Experts rated patients' MDD with the Montgomery-Asberg Depression Rating Scale. RESULTS: Patients did not differ in experts' ratings of symptoms of depression. Compared to healthy controls, patients with MDD recorded higher scores on maladaptive schemas such as recognition seeking, negativity/pessimism, and insufficient self-control. Compared to patients without suicide attempts and healthy controls, those who had made a suicide attempt had higher scores on dimensions such as failure, mistrust, emotional inhibition, social isolation, and abandonment/instability. CONCLUSION: Compared to healthy controls, patients with MDD had more pronounced maladaptive schemas, but this was more marked in patients with a history of suicide attempts. The results suggest that suicide attempts and poorer psychological functioning are related.

Repetitive Transcranial Magnetic Stimulation Improved Symptoms of Obsessive-Compulsive Disorder, but Also Cognitive Performance: Results from a Randomized Clinical Trial with a Cross-Over Design and Sham Condition.

OBJECTIVE: There is some evidence that repetitive transcranial magnetic stimulation (rTMS) is an effective method of treating patients suffering from obsessive-compulsive disorder (OCD). Here, we tested the hypothesis that rTMS has a positive impact both on symptom severity and cognitive performance in such patients. Specifically, short-term verbal processing speed and flexibility were assessed. METHOD: Ten patients suffering from refractory OCD and treated with standard medication were randomly assigned either to a treatment-first or to a sham-first condition. At baseline and after 2 and 4 weeks, symptom severity (experts' ratings) and cognitive performance (auditory perception, visual perception, short-term memory, and processing speed) were assessed. After 2 weeks, the treatment condition switched to the sham condition, and the sham condition switched to the treatment condition. RESULTS: Under treatment but not under sham conditions, symptom severity reduced. Moreover, cognitive performance improved in parallel. CONCLUSIONS: rTMS is a safe and efficient treatment for patients suffering from refractory OCD; symptoms and cognitive performance improved in parallel.

Repetitive Transcranial Magnetic Stimulation Improved Symptoms of Obsessive-Compulsive Disorders but Not Executive Functions: Results from a Randomized Clinical Trial with Crossover Design and Sham Condition.

OBJECTIVE: Whereas there is growing evidence that repetitive transcranial magnetic stimulation (rTMS) favorably impacts on symptoms of obsessive-compulsive disorders (OCD), less is known regarding the influence of rTMS on cognitive performance of patients with OCD. Here, we tested the hypothesis that rTMS has a positive impact both on symptom severity and executive functions in such patients. METHODS: We assessed 10 patients diagnosed with OCD (mean age: 33.5 years) and treated with a standard medication; they were randomly assigned either to a treatment-first or to a sham-first condition. Symptom severity (experts' ratings) and executive functions (Wisconsin Card Sorting Test) were assessed by independent raters unaware of the patients' group assignments at baseline, after 2 and 4 weeks. After 2 weeks, treatment switched to sham condition, and sham condition switched to treatment condition. RESULTS: Under treatment but not under sham conditions, symptom severity decreased. Performance on the executive function test increased continuously with every new assessment and was unrelated to rTMS treatment. CONCLUSION: Whereas the present study confirmed previous research suggesting that rTMS improved symptoms of OCD, rTMS did not improve executive functions to a greater degree than sham treatment. More research is needed to investigate the effect of rTMS on executive functions in patients with OCD.

Adjuvant thiamine improved standard treatment in patients with major depressive disorder: results from a randomized, double-blind, and placebo-controlled clinical trial.

Given that antidepressants (ADs) work slowly, there is interest in means to accelerate their therapeutic effect and to reduce side effects. In this regard, thiamine (vitamin B1) is attracting growing interest. Thiamine is an essential nutrient, while thiamine deficiency leads to a broad variety of disorders including irritability and symptoms of depression. Here, we tested the hypothesis that adjuvant thiamine would reduce depression, compared to placebo. A total of 51 inpatients (mean age: 35.2 years; 53 % females) with MDD (Hamilton Depression Rating Scale score (HDRS) at baseline: >24) took part in the study. A standardized treatment with SSRI was introduced and kept at therapeutic levels throughout the study. Patients were randomly assigned either to the thiamine or the placebo condition. Experts rated (HDRS) symptoms of depression at baseline, and after 3, 6, and 12 weeks (end of the study). Between baseline and the end of the study, depression had reduced in both groups. Compared to placebo, adjuvant thiamine improved symptoms of depression after 6 week of treatment, and improvements remained fairly stable until the end of the study, though mean differences at week 12 were not statistically significant anymore. No adverse side effects were reported in either group. Results suggest that among younger patients with MDD adjuvant thiamine alleviated symptoms of depression faster compared to placebo. Importantly, improvements were observed within 6 weeks of initiation of treatment. Thus, thiamine might have the potential to counteract the time lag in the antidepressant effects of ADs.

Levels of mania and cognitive performance two years after ECT in patients with bipolar I disorder - results from a follow-up study.

BACKGROUND: There is limited evidence on the long-term outcomes for patients with bipolar I disorder (BP-I-D) and treated with ECT. Therefore, we asked whether mania scores and cognitive performance at the end of ECT treatment (baseline/BL) predicted mania scores, cognitive performance, recurrence, treatment adherence, and mood (depression; hypomania) two years later (follow-up/FU). METHOD: 38 patients with BP-I-D undergoing ECT at baseline were followed up two years later. A brief psychiatric and cognitive assessment (Mini Mental State Examination; short-term verbal memory test) was performed; patients completed questionnaires covering recurrence, treatment adherence, and mood (depression; hypomania). RESULTS: High cognitive performance at BL predicted high cognitive performance at FU; low mania scores at BL predicted low mania scores at FU. By FU, cognitive performance had increased and mania scores decreased. Mania scores and cognitive performance at BL did not predict recurrence, or adherence to medication, or mood (depression; hypomania). CONCLUSIONS: The pattern of results suggests that after two years of successful treatment of acute mania with ECT, cognitive impairment, measured by MMSE and a short-term verbal memory test, is not impaired and mood symptom recurrence seems to be improved. Mania scores and cognitive performance at the end of ECT treatment predicted neither mood (depression; hypomania), nor recurrence, or adherence to medication two years later.

No evidence for metabolic syndrome and lipid profile differences in patients suffering from bipolar I disorder with and without suicide attempts.

OBJECTIVE: The aim of the present study was to provide further evidence of (1) metabolic syndrome and blood lipid profile differences between suicide attempting and non-attempting patients with bipolar disorder (BPD) I and to assess these differences (2) as a function of acute depressive or manic phase. METHODS: Fifty inpatients (mean age: 36.14 years 48% males) with BPD I took part in the study. After recruitment, patients were clustered in four groups: 13 suicide attempters (SAs) assessed during a manic phase, 12 SAs assessed during a depressive phase, 15 non-SAs assessed during a manic phase, and 10 non-SAs assessed during a depressive phase. Body mass index (BMI), metabolic syndrome, blood pressure, blood lipids (cholesterol, high- and low-density lipids, and triglyceride), and fasting blood sugar were assessed. RESULTS: Neither metabolic syndrome, blood lipid values, fasting blood sugar, nor BMI or blood pressure differed between the SAs and non-SAs, or between patients in an acute manic phase and those in a depressed phase. The overall prevalence of metabolic syndrome was 26.0%. CONCLUSION: Among patients with BPD I neither the occurrence of metabolic syndrome nor lipid values or fasting blood sugar are reliable biomarkers of suicidal behavior during either acute depressive or manic phase.

Oral loading of sodium valproate compared to intravenous loading and oral maintenance in acutely manic bipolar patients.

BACKGROUND: In patients suffering from bipolar disorders (BPD), we explored to what extent oral loading of sodium valproate (SV) leads to more rapid symptom improvement compared to intravenous loading and oral maintenance administration. METHODS: Ninety patients (mean age: 35.00 years) with BPD and currently in an acute manic state were randomly assigned to one of three study conditions: oral loading (20 mg/kg oral single-dose SV on the first day, then 10-15 mg/kg SV daily, divided dose), intravenous loading (20 mg/kg SV intravenous injection on the first day, then 10-15 mg/kg orally, divided dose), or oral maintenance administration (15-20 mg/kg SV daily from the beginning) over the first 7 days of treatment. SV plasma levels, side effects and symptoms were evaluated at baseline and on days 1, 3, and 7 after commencing treatment. RESULTS: There were significant Time-by-Group interactions for symptom improvements, symptom severity, and SV plasma levels, with positive values in the oral and intravenous loading conditions, compared to the oral maintenance condition. Post hoc analyses showed that oral and intravenous conditions led to similar improvements. CONCLUSIONS: Both oral and intravenous loading of SV led to quicker and more efficient improvement and SV plasma levels as compared to an oral maintenance regimen.

Comparing the effect of prazosin and hydroxyzine on sleep quality in patients suffering from posttraumatic stress disorder.

OBJECTIVES: In light of the high prevalence of sleep disorders in patients suffering from posttraumatic stress disorder (PTSD), this study sought to compare the effect of prazosin and hydroxyzine on sleep quality in this patient group. METHODS: A total of 100 patients suffering from PTSD were assessed (mean age = 35.51 years, SD = 6.41; 28% females). Next, they were randomly assigned to one of three treatment groups: prazosin (33 patients), hydroxyzine (34 patients) or placebo (33 patients). The trial lasted for 8 weeks. The patients' sleep quality was assessed using the Pittsburgh Sleep Quality Index. Items taken from the Mini International Neuropsychiatric Interview were used to operationalize PTSD. RESULTS: Compared to controls, patients treated with prazosin and hydroxyzine reported improved sleep and less nightmares. Improvement was greatest in patients treated with prazosin compared to hydroxyzine and placebo. Improvement in sleep was associated with an amelioration of their PTSD symptoms. CONCLUSION: Both prazosin and hydroxyzine can be used to treat psychopharmacological sleep disorders and nightmares in patients suffering from PTSD, also leading to reductions in PTSD symptoms.

Among a sample of Iranian premenopausal and menopausal women differences in mood, sleep and health quality are small.

BACKGROUND: Anecdotal evidence suggests that mood, sleep, and health quality change in women from premenopausal to menopausal period; however, data supporting these assumptions from non-Western countries are scarce. The aim of the present study was therefore to assess premenopausal and menopausal Iranian women with regard to mood, sleep, and general health. METHODS: One hundred and twenty Iranian women took part in the study. Sixty were in a premenopausal state (mean age (M): = 46.9 years) and 60 in a menopausal state (M = 53.8 years). They completed a series of self-rating questionnaires related to sleep, mood, and health quality. RESULTS: Compared to premenopausal women, menopausal women reported more difficulties such as falling asleep, and less general physical activities and vitality. No statistically significant differences were found for sleep quality, sleep schedules, difficulties in social life, general mood state, or general physical and mental health. Menopausal women reported to be more irritable, and to have more energy. CONCLUSIONS: Data suggest that among a sample of Iranian premenopausal and menopausal women, differences in mood, sleep, and general health are small. Data, therefore, do not support "beliefs" and hearsay that mood, sleep, and general health do decrease from premenopausal to menopausal state.

Assessment of cognitive impairments and seizure characteristics in electroconvulsive therapy with and without sodium valproate in manic patients.

OBJECTIVES: The aim of the present study was two-fold: (1) to compare, in a controlled double-blind quasi-randomized clinical trial, treatment improvements, treatment outcome, and cognitive impairments in patients suffering from current manic episodes, while treated with electroconvulsive therapy (ECT) with and without concurrent sodium valproate therapy, and (2) to compare ECT seizure characteristics in patients with and without concurrent sodium valproate therapy. METHODS: A total of 40 inpatients (mean age = 31.80 years, SD = 8.06; 75% males) suffering from bipolar disorders and currently in a manic state took part in the study. They were quasi-randomly assigned either to the target (continuation of sodium valproate administration) or to the control group (discontinuation of sodium valproate administration). All patients underwent bifrontal ECT for at least 6 sessions. Improvements and cognitive impairments were assessed, and seizure characteristics (duration, threshold) were also recorded. RESULTS: Manic episodes improved significantly over time, and irrespective of the group (target vs. control group). Cognitive impairments did not alter over time or between groups. Seizure duration did not change over time or between groups. Seizure threshold did not change over time, but was lower in the target than in the control group. CONCLUSIONS: Continuing the administration of sodium valproate neither adversely affects, nor enhances cognitive impairments or seizure duration, but reduces seizure threshold during ECT in patients suffering from manic episodes. Moreover, gender appeared to be more strongly associated with cognitive impairment and seizure activity than treatment approaches in these psychiatric conditions.

Among a sample of Iranian students, adult attention deficit hyperactivity disorder is related to childhood ADHD, but not to age, gender, socioeconomic status, or birth order--an exploratory study.

OBJECTIVE: The aim of the present study was to explore the prevalence of adult attention deficit hyperactivity disorder (ADHD) in young adult Iranian students and to examine gender, birth order, socioeconomic status (SES), and history of ADHD as potential predictors of adult ADHD. METHODS: A total of 387 young adult students (mean age: 19.6 years; 66.3% females) completed the Adult ADHD Self-Report Scale-V1.1 symptom checklist to assess current symptoms of ADHD and the Wender Utah Rating Scale to assess symptoms of ADHD in childhood and adolescence. Experts' ratings were based on Wender-Reimherr Interview. RESULTS: Self-rated and expert-rated prevalence rates were 16.5% and 13.4%, respectively. Past symptoms of ADHD were correlated with current symptoms. Childhood ADHD, current hyperactivity, and disorganization predicted current ADHD. CONCLUSIONS: Among a sample of Iranian students, the prevalence rates of ADHD were higher than estimated rates worldwide. Data also show child ADHD to be associated with adult ADHD; gender, age, birth order, and SES did not seem to influence current symptomatology.

How common is attention deficit hyperactivity disorder (ADHD) in a cohort of children with functional constipation, and does ADHD treatment improve functional constipation?

Introduction: Attention deficit hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders in children. Functional constipation is common in children and has a significant impact on the quality of their life, affecting both physical and emotional well-being. The aim of this study was to evaluate the frequency of ADHD in functional constipation patients and its treatment effect on constipation. Material and methods: In this clinical trial study, 80 children with simultaneous ADHD and functional constipation were allocated to two equal groups by the block randomization method. One group was treated only with ADHD drugs and the second group was treated for ADHD and functional constipation. Subsequently, the treatment outcome was evaluated in both groups. Results: The frequency of ADHD in functional constipation patients was 13.87%. The frequency of functional constipation recovery in the first and second group was respectively 2 (5%) and 39 (97.5%) (p < 0.001). ADHD treatment has no significant effect on the recovery of constipation. There was no statistically significant relationship between the response to treatment with age, sex and duration of having ADHD and constipation. Conclusions: In patients with simultaneous ADHD and functional constipation, ADHD treatment did not influence the recovery of functional constipation and vice versa.

Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) Add-On Therapy to a Standard Treatment in Individuals with Multiple Sclerosis and Concomitant Symptoms of Depression-Results from a Randomized Clinical Trial and Pilot Study.

BACKGROUND: Compared to the general population, persons with multiple sclerosis (MS) are at increased risk of suffering from major depressive disorder (MDD). Repetitive Transcranial Magnetic Stimulation (rTMS) was used successfully to treat individuals with MDD. Here, we conducted a randomized clinical trial and pilot study, and tested the effectiveness of rTMS adjuvant to a standard pharmacological treatment among persons with MS, compared to a sham condition. MATERIALS AND METHODS: A total of 40 persons with MS (mean age: 32 years; 42.5% females; median EDSS score: 4) and with moderate to severe symptoms of depression were randomly assigned to the rTMS or to the rTMS sham condition, always as adjuvant intervention to the standard treatment with sertraline, a selective serotonin reuptake inhibitor (SSRI). rTMS consisted of 10 sessions each of 37.5 min; the sham condition was identical to the active condition except for the absence of rTMS stimuli. At the beginning and two weeks after the end of the study, participants reported on their fatigue, while experts rated the severity of participants' depressive symptoms (Montgomery-Asberg Depression Rating Scale; MADRS), cognitive performance (Montreal Cognitive Assessment; MoCA), and degree of disability (Expanded Disability Status Scale; EDSS). RESULTS: Data were analyzed per intent-to-treat. Scores for depression, fatigue, and EDSS declined significantly over time (large effect sizes), but more so in the rTMS condition than in the sham condition (large effect sizes for the time by group-interactions). Compared to the sham condition, scores for depression were significantly lower in the rTMS condition. Scores for cognition improved over time in both study conditions (large effect size). CONCLUSION: Compared to a sham condition, adjuvant rTMS to a standard pharmacological treatment ameliorated typical MS-related symptoms (depression; fatigue; EDSS scores). Results from this pilot study suggested that rTMS might be routinely applied in persons with MS displaying symptoms of depression and fatigue.

Association of MGLL Intronic C>T Single Nucleotide Polymorphism (rs782440) with Borderline Personality Disorder: A Case-Control Study.

OBJECTIVE: From the perspective of etiology, borderline personality disorder (BPD) is a multifactorial and complex disorder, hence our understanding about the molecular basis and signaling of this disorder is extremely limited. The purpose of this study was evaluating the relationship between BPD and the Monoacylglycerol lipase (MGLL) polymorphism rs782440 in the population of Hamadan, Iran. MATERIALS AND METHODS: In this case-control study, 106 participants including 53 patients with BPD and 53 healthy control subjects were selected by psychiatrists in the Department of Psychiatry at Farshchian Sina Hospital in Hamadan. The BPD patients were selected based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) form for diagnosing BPD patients. For genotyping, polymerase chain reaction (PCR) was used to amplify the desired region including the (MGLL) intronic C>T single nucleotide polymorphism (SNP) (rs782440) and afterward the amplicon was sequenced using the Sanger sequencing method. To determine the genotype of these patients, their sequences were aligned with the reference sequence of MGLL through the CLC genomic workbench software. RESULTS: The results indicated that the frequency of TT in comparison to the CC genotype was significantly different (P=0.003) and the risk of BPD in change from the TT genotype to CC genotype was increased by 6.679%. Regarding the frequency of allele in this group, no significant difference was observed. CONCLUSION: This paper, has studied and reports for the first time, the association between MGLL SNP (rs782440) with BPD. The findings of the current research revealed that the TT genotype increases the risk of BPD compared to the CC genotype. Considering the lack of a suitable diagnostic biomarker for BPD, using this potential biomarker in the near future can be promising.