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Bob Dylan grew up in Hibbing, Minnesota, during the 1950s, where the opportunity to hear folk music was something of a rarity. Indeed, the young Robert Zimmerman was hooked on R&B (black) and rock ’n’ roll (white). This was the soundtrack for teens at that time, and he even played the piano, as well as the acoustic and electric guitar, in local bands. It was not until Dylan moved to Minneapolis in 1959, he long contended, that he discovered folk music, particularly its early roots in recorded blues and country music, and especially Woody Guthrie, who would become his role model.
This study aimed to develop, validate and compare the performance of models predicting post-treatment outcomes for depressed adults based on pre-treatment data.
Individual patient data from all six eligible randomised controlled trials were used to develop (k = 3, n = 1722) and test (k = 3, n = 918) nine models. Predictors included depressive and anxiety symptoms, social support, life events and alcohol use. Weighted sum scores were developed using coefficient weights derived from network centrality statistics (models 1–3) and factor loadings from a confirmatory factor analysis (model 4). Unweighted sum score models were tested using elastic net regularised (ENR) and ordinary least squares (OLS) regression (models 5 and 6). Individual items were then included in ENR and OLS (models 7 and 8). All models were compared to one another and to a null model (mean post-baseline Beck Depression Inventory Second Edition (BDI-II) score in the training data: model 9). Primary outcome: BDI-II scores at 3–4 months.
Models 1–7 all outperformed the null model and model 8. Model performance was very similar across models 1–6, meaning that differential weights applied to the baseline sum scores had little impact.
Any of the modelling techniques (models 1–7) could be used to inform prognostic predictions for depressed adults with differences in the proportions of patients reaching remission based on the predicted severity of depressive symptoms post-treatment. However, the majority of variance in prognosis remained unexplained. It may be necessary to include a broader range of biopsychosocial variables to better adjudicate between competing models, and to derive models with greater clinical utility for treatment-seeking adults with depression.
Targeted drug development efforts in patients with CHD are needed to standardise care, improve outcomes, and limit adverse events in the post-operative period. To identify major gaps in knowledge that can be addressed by drug development efforts and provide a rationale for current clinical practice, this review evaluates the evidence behind the most common medication classes used in the post-operative care of children with CHD undergoing cardiac surgery with cardiopulmonary bypass.
We systematically searched PubMed and EMBASE from 2000 to 2019 using a controlled vocabulary and keywords related to diuretics, vasoactives, sedatives, analgesics, pulmonary vasodilators, coagulation system medications, antiarrhythmics, steroids, and other endocrine drugs. We included studies of drugs given post-operatively to children with CHD undergoing repair or palliation with cardiopulmonary bypass.
We identified a total of 127 studies with 51,573 total children across medication classes. Most studies were retrospective cohorts at single centres. There is significant age- and disease-related variability in drug disposition, efficacy, and safety.
In this study, we discovered major gaps in knowledge for each medication class and identified areas for future research. Advances in data collection through electronic health records, novel trial methods, and collaboration can aid drug development efforts in standardising care, improving outcomes, and limiting adverse events in the post-operative period.
This study aimed to investigate general factors associated with prognosis regardless of the type of treatment received, for adults with depression in primary care.
We searched Medline, Embase, PsycINFO and Cochrane Central (inception to 12/01/2020) for RCTs that included the most commonly used comprehensive measure of depressive and anxiety disorder symptoms and diagnoses, in primary care depression RCTs (the Revised Clinical Interview Schedule: CIS-R). Two-stage random-effects meta-analyses were conducted.
Twelve (n = 6024) of thirteen eligible studies (n = 6175) provided individual patient data. There was a 31% (95%CI: 25 to 37) difference in depressive symptoms at 3–4 months per standard deviation increase in baseline depressive symptoms. Four additional factors: the duration of anxiety; duration of depression; comorbid panic disorder; and a history of antidepressant treatment were also independently associated with poorer prognosis. There was evidence that the difference in prognosis when these factors were combined could be of clinical importance. Adding these variables improved the amount of variance explained in 3–4 month depressive symptoms from 16% using depressive symptom severity alone to 27%. Risk of bias (assessed with QUIPS) was low in all studies and quality (assessed with GRADE) was high. Sensitivity analyses did not alter our conclusions.
When adults seek treatment for depression clinicians should routinely assess for the duration of anxiety, duration of depression, comorbid panic disorder, and a history of antidepressant treatment alongside depressive symptom severity. This could provide clinicians and patients with useful and desired information to elucidate prognosis and aid the clinical management of depression.
Antidepressant medication and interpersonal psychotherapy (IPT) are both recommended interventions in depression treatment guidelines based on literature reviews and meta-analyses. However, ‘conventional’ meta-analyses comparing their efficacy are limited by their reliance on reported study-level information and a narrow focus on depression outcome measures assessed at treatment completion. Individual participant data (IPD) meta-analysis, considered the gold standard in evidence synthesis, can improve the quality of the analyses when compared with conventional meta-analysis.
We describe the protocol for a systematic review and IPD meta-analysis comparing the efficacy of antidepressants and IPT for adult acute-phase depression across a range of outcome measures, including depressive symptom severity as well as functioning and well-being, at both post-treatment and follow-up (PROSPERO: CRD42020219891).
We will conduct a systematic literature search in PubMed, PsycINFO, Embase and the Cochrane Library to identify randomised clinical trials comparing antidepressants and IPT in the acute-phase treatment of adults with depression. We will invite the authors of these studies to share the participant-level data of their trials. One-stage IPD meta-analyses will be conducted using mixed-effects models to assess treatment effects at post-treatment and follow-up for all outcome measures that are assessed in at least two studies.
This will be the first IPD meta-analysis examining antidepressants versus IPT efficacy. This study has the potential to enhance our knowledge of depression treatment by comparing the short- and long-term effects of two widely used interventions across a range of outcome measures using state-of-the-art statistical techniques.
To determine whether age, gender and marital status are associated with prognosis for adults with depression who sought treatment in primary care.
Medline, Embase, PsycINFO and Cochrane Central were searched from inception to 1st December 2020 for randomised controlled trials (RCTs) of adults seeking treatment for depression from their general practitioners, that used the Revised Clinical Interview Schedule so that there was uniformity in the measurement of clinical prognostic factors, and that reported on age, gender and marital status. Individual participant data were gathered from all nine eligible RCTs (N = 4864). Two-stage random-effects meta-analyses were conducted to ascertain the independent association between: (i) age, (ii) gender and (iii) marital status, and depressive symptoms at 3–4, 6–8,<Vinod: Please carry out the deletion of serial commas throughout the article> and 9–12 months post-baseline and remission at 3–4 months. Risk of bias was evaluated using QUIPS and quality was assessed using GRADE. PROSPERO registration: CRD42019129512. Pre-registered protocol https://osf.io/e5zup/.
There was no evidence of an association between age and prognosis before or after adjusting for depressive ‘disorder characteristics’ that are associated with prognosis (symptom severity, durations of depression and anxiety, comorbid panic disorderand a history of antidepressant treatment). Difference in mean depressive symptom score at 3–4 months post-baseline per-5-year increase in age = 0(95% CI: −0.02 to 0.02). There was no evidence for a difference in prognoses for men and women at 3–4 months or 9–12 months post-baseline, but men had worse prognoses at 6–8 months (percentage difference in depressive symptoms for men compared to women: 15.08% (95% CI: 4.82 to 26.35)). However, this was largely driven by a single study that contributed data at 6–8 months and not the other time points. Further, there was little evidence for an association after adjusting for depressive ‘disorder characteristics’ and employment status (12.23% (−1.69 to 28.12)). Participants that were either single (percentage difference in depressive symptoms for single participants: 9.25% (95% CI: 2.78 to 16.13) or no longer married (8.02% (95% CI: 1.31 to 15.18)) had worse prognoses than those that were married, even after adjusting for depressive ‘disorder characteristics’ and all available confounders.
Clinicians and researchers will continue to routinely record age and gender, but despite their importance for incidence and prevalence of depression, they appear to offer little information regarding prognosis. Patients that are single or no longer married may be expected to have slightly worse prognoses than those that are married. Ensuring this is recorded routinely alongside depressive ‘disorder characteristics’ in clinic may be important.
COVID-19 has caused a major global pandemic and necessitated unprecedented public health restrictions in almost every country. Understanding risk factors for severe disease in hospitalised patients is critical as the pandemic progresses. This observational cohort study aimed to characterise the independent associations between the clinical outcomes of hospitalised patients and their demographics, comorbidities, blood tests and bedside observations. All patients admitted to Northwick Park Hospital, London, UK between 12 March and 15 April 2020 with COVID-19 were retrospectively identified. The primary outcome was death. Associations were explored using Cox proportional hazards modelling. The study included 981 patients. The mortality rate was 36.0%. Age (adjusted hazard ratio (aHR) 1.53), respiratory disease (aHR 1.37), immunosuppression (aHR 2.23), respiratory rate (aHR 1.28), hypoxia (aHR 1.36), Glasgow Coma Scale <15 (aHR 1.92), urea (aHR 2.67), alkaline phosphatase (aHR 2.53), C-reactive protein (aHR 1.15), lactate (aHR 2.67), platelet count (aHR 0.77) and infiltrates on chest radiograph (aHR 1.89) were all associated with mortality. These important data will aid clinical risk stratification and provide direction for further research.
To characterize associations between exposures within and outside the medical workplace with healthcare personnel (HCP) SARS-CoV-2 infection, including the effect of various forms of respiratory protection.
We collected data from international participants via an online survey.
In total, 1,130 HCP (244 cases with laboratory-confirmed COVID-19, and 886 controls healthy throughout the pandemic) from 67 countries not meeting prespecified exclusion (ie, healthy but not working, missing workplace exposure data, COVID symptoms without lab confirmation) were included in this study.
Respondents were queried regarding workplace exposures, respiratory protection, and extra-occupational activities. Odds ratios for HCP infection were calculated using multivariable logistic regression and sensitivity analyses controlling for confounders and known biases.
HCP infection was associated with non–aerosol-generating contact with COVID-19 patients (adjusted OR, 1.4; 95% CI, 1.04–1.9; P = .03) and extra-occupational exposures including gatherings of ≥10 people, patronizing restaurants or bars, and public transportation (adjusted OR range, 3.1–16.2). Respirator use during aerosol-generating procedures (AGPs) was associated with lower odds of HCP infection (adjusted OR, 0.4; 95% CI, 0.2–0.8, P = .005), as was exposure to intensive care and dedicated COVID units, negative pressure rooms, and personal protective equipment (PPE) observers (adjusted OR range, 0.4–0.7).
COVID-19 transmission to HCP was associated with medical exposures currently considered lower-risk and multiple extra-occupational exposures, and exposures associated with proper use of appropriate PPE were protective. Closer scrutiny of infection control measures surrounding healthcare activities and medical settings considered lower risk, and continued awareness of the risks of public congregation, may reduce the incidence of HCP infection.
Previous genetic association studies have failed to identify loci robustly associated with sepsis, and there have been no published genetic association studies or polygenic risk score analyses of patients with septic shock, despite evidence suggesting genetic factors may be involved. We systematically collected genotype and clinical outcome data in the context of a randomized controlled trial from patients with septic shock to enrich the presence of disease-associated genetic variants. We performed genomewide association studies of susceptibility and mortality in septic shock using 493 patients with septic shock and 2442 population controls, and polygenic risk score analysis to assess genetic overlap between septic shock risk/mortality with clinically relevant traits. One variant, rs9489328, located in AL589740.1 noncoding RNA, was significantly associated with septic shock (p = 1.05 × 10–10); however, it is likely a false-positive. We were unable to replicate variants previously reported to be associated (p < 1.00 × 10–6 in previous scans) with susceptibility to and mortality from sepsis. Polygenic risk scores for hematocrit and granulocyte count were negatively associated with 28-day mortality (p = 3.04 × 10–3; p = 2.29 × 10–3), and scores for C-reactive protein levels were positively associated with susceptibility to septic shock (p = 1.44 × 10–3). Results suggest that common variants of large effect do not influence septic shock susceptibility, mortality and resolution; however, genetic predispositions to clinically relevant traits are significantly associated with increased susceptibility and mortality in septic individuals.
Persistent methicillin-resistant Staphylococcus aureus (MRSA) infection in cystic fibrosis (CF) patients has been associated with a more rapid decline in lung function, increased hospitalisation and mortality. The aim of this study was to evaluate the clonal relationships among 116 MRSA isolates from 12 chronically colonised CF pediatric patients over a 6-year period in a Rio de Janeiro CF specialist centre. Isolates were characterised by antimicrobial resistance, SCCmec type, presence of Panton-Valentine Leukocidin (PVL) genes and grouped according to DNA macrorestriction profile by pulsed-field gel electrophoresis (PFGE) and spa gene type. High resistance rates were detected for erythromycin (78%) and ciprofloxacin (50%) and SCCmec IV was the most common type (72.4%). Only 8.6% of isolates were PVL positive. High genetic diversity was evident by PFGE (39 pulsotypes) and of nine that were identified spa types, t002 (53.1%) and t539 (14.8%) were the most prevalent. We conclude that the observed homogeneity of spa types within patients over the study period demonstrates the persistence of such strain lineages throughout the course of chronic lung infection.
Le parcours de soins des patients atteints de TDA/H est mal connu. Cette enquête nationale a pour objectif de préciser les étapes d’évaluation successives menant au diagnostic ainsi qu’au traitement du TDA/H et d’identifier des éléments susceptibles d’être améliorés.
Enquête transversale menée en France du 04/11/2013 au 31/01/2014 auprès d’un échantillon national de 61 médecins prenant en charge des enfants atteints de TDA/H, à l’aide d’un auto-questionnaire remis aux patients/parents.
Quatre cent soixante-treize questionnaires analysés. Les premiers signes (troubles du comportement [78,2 %] et de l’attention [70 %]) sont repérés vers 4,5 ans, principalement hors du milieu familial. Le diagnostic est posé à l’âge de 8,1 ans, environ 4 ans après l’observation des premiers signes. Les familles consultent en moyenne 3,5 professionnels de santé avant que le diagnostic ne soit évoqué. Le psychiatre/pédopsychiatre est le plus consulté quelle que soit l’étape d’évaluation. Lors de la 1re étape, seuls 10,7 % des patients sont diagnostiqués. Ce délai pourrait en partie expliquer les taux élevés de redoublement (31,5 %), notamment en CP et CE1, et d’insatisfaction vis-à-vis de la prise en charge, principalement lors de la 1re étape d’évaluation (38,6 % d’insatisfaits). Deux groupes de patients ont été mis en évidence par une analyse en cluster : le premier (89,9 % de garçons) présente des problèmes de comportement, d’agitation, et des difficultés familiales ; le 2e (49 % de garçons), dont l’hyperactivité est moins prononcée, a mis une année supplémentaire pour recevoir un diagnostic de TDA/H. Dans cet échantillon, plus de 2/3 des patients bénéficient d’un traitement médicamenteux, du méthylphénidate dans 98 % des cas. Le diagnostic tardif a été la principale source de préoccupation des proches.
Le délai d’environ 4 ans, des premiers signes au diagnostic, pourrait constituer une perte de chance pour les enfants atteints de TDA/H.
Life expectancy in schizophrenia is shortened, 15 years to 32 years. Increased cardiovascular morbidity is thought to have a major contribution.
A nurse practitioner was appointed for metabolic screening. The cut-off points were according to the NCEP 2005 criteria, except for glucose (cut-off: 6,0 mmol/l).
All outpatients in two FACT teams in Alkmaar were asked to participate in the measurement of the metabolic syndrome. Blood pressure was twice measured at two different visits, that took place 4 weeks apart. If laboratory result was abnormal, the measurement was repeated.
Out of the 204 patients in outpatient care who were asked, 67 refused participation. All in all, 137 patients participated, 91 male (46,3 years (SD: 12,2) and 46 female (51,7 yrs; SD: 11,6) patients. The vast majority (N=126 (92,6%) were Caucasian. Obesity was present in 32% of the male and 48% of the female patients compared to 16% in the general population. Normoglycemia was established in only 72,2% of the population compared to 95% in the same aged general population. Repeated hyperglycemia was present in 24,1% of the population.
In 137 patients with severe mental illness, mean age 48 years, we found that
1. obesity was twice as prevalent as in the patient population.
2. using the conservative NECP 2001 criterion for hyperglycemia, one out of four patients had a confirmed pre-diabetic hyperglycemia.
Intensive screening, therapy and preferably prevention are advised and needed to prevent major medical costs and massive medial consumption in this high-risk population.
People with severe mental illnesses, such as schizophrenia, depression or bipolar disorder, have worse physical health and reduced life expectancy compared to the general population. The excess cardiovascular mortality associated with schizophrenia and bipolar disorder is attributed in part to an increased risk of the modifiable coronary heart disease risk factors; obesity, smoking, diabetes, hypertension, and dyslipidaemia.
Over recent years both national and international groups have developed screening and monitoring guidelines but these are not being routinely implemented in the clinical care of patients. A review of the literature identifies barriers to comprehensive screening, monitoring and treatment of somatic co-morbidities on the level of professionals (both within psychiatry as well as in primary care), patients, health care systems (organisational and financial aspects) and health policies.
Psychiatrists and primary care physicians should play an active role in ensuring that patients with mental illness are not disadvantaged. Measures should include the assessment and management of cardiovascular risk factors and diabetes as part of the care of their psychiatric patients. When indicated, shared care with cardiologists, diabetologists, specialist nurses or other specialists should be established.
The aim of the recent joint statement on cardiovascular disease an diabetes in people with severe mental illness of the EPA, EASD and ESC is to reduce cardiovascular risk and to improve diabetes care in patients with SMI and to improve overall health and well-being of the patients (De Hert et al. 2009). This should reduce the burden of physical illness for patients, their families and healthcare services.
Second-generation antipsychotics (SGA) are being used more often than ever before in children and adolescents with psychotic and a wide range of non-psychotic disorders. Several SGA have received regulatory approval for some paediatric indications in various countries, but off-label use is still frequent. The aim of this paper was to perform a systematic review and critically evaluate the literature on cardiometabolic and endocrine side-effects of SGA in children and adolescents through a Medline/Pubmed/Google Scholar search of randomized, placebo controlled trials of antipsychotics in children and adolescents (<18 years old) until February 2010. In total, 31 randomized, controlled studies including 3595 paediatric patients were identified. A review of these data confirmed that SGA are associated with relevant cardiometabolic and endocrine side-effects, and that children and adolescents have a high liability to experience antipsychotic induced hyperprolactinaemia, weight gain and associated metabolic disturbances. Only weight change data were sufficiently reported to conduct a formal meta-analysis. In 24 trials of 3048 paediatric patients with varying ages and diagnoses, ziprasidone was associated with the lowest weight gain (−0.04 kg, 95% confidence interval [CI]: −0.38 to +0.30), followed by aripiprazole (0.79 kg, 95% CI: 0.54 to 1.04], quetiapine (1.43 kg, 95% CI: 1.17 to 1.69) and risperidone (1.76 kg, 95% CI: 1.27 to 2.25) were intermediate, and olanzapine was associated with weight gain the most (3.45 kg, 95% CI: 2.93 to 3.97). Significant weight gain appeared to be more prevalent in patients with autistic disorder who were also younger and likely less exposed to antipsychotics previously. These data clearly suggest that close screening and monitoring of metabolic side effects is warranted and that the least cardiometabolically problematic agents should be used first whenever possible. A good collaboration between child- and adolescent psychiatrists, general practitioners and paediatricians is essential to maximize overall outcomes and to reduce the likelihood of premature cardiovascular morbidity and mortality.
Study of risk factors of diabetes mellitus from the general population in a schizophrenic population.
Measurement of glucose and insuline levels, fasting and 120’ after oral glucose tolerance test (OGTT) and calculating of HOMA-IR and HOMA-B.
We studied 167 outpatients, mean age 40.2 years, 90.9% Caucasian, suffering from schizophrenia (83%) or schizoaffective disorder (17%).
Age could not be confirmed as a risk factor on any of the glucose or insuline measurements or HOMA in patients with typical or atypical antipsychotics.
With bodyweight, patients with typical differed from those with atypical antipsychotics. Weight was not a risk factor on any measurement or model in with typical antipsychotics. In patients with atypical, a significant correlation with levels of plasma glucose (p=0.017), insuline (p= 0.003 resp. p= 0.010) or glucose homeostasis models (p= 0.004 resp. p= 0.016). Fasting plasma glucose (FPG) was the notable exception (p=0.987).
Diabetes risk factors age and weight behave differently in schizophrenia or schizoaffective disorder.
The finding that age was not a risk factor, suggests that age is not a suitable criterion for the decision of glucose screening in this population.
The different effect of weight (a risk factor only in patients treated with atypical, but not with typical antipsychotics) suggests in different pathophysiological pathway.
As FPG was the only measurement with no correlation with either risk factors, this suggests that FPG is insufficiently sensitive for detection of disturbed glucosemetabolism in schizophrenia. Additional measurements (fasting insuline, HOMA-IR, HOMA-B, OGTT) seem to be necessary.
Given the limited knowledge on the long-term outcome of adolescents who receive electroconvulsive therapy (ECT), the study aimed to follow-up adolescents treated with ECT for severe mood disorder. Eleven subjects treated during adolescence with bilateral ECT for psychotic depression (n = 6) or mania (n = 5), and ten psychiatric controls matched for sex, age, school level, and clinical diagnosis, completed at least 1 year after treatment a clinical and social evaluation. Mean duration between time of index episode and time of follow-up evaluation was 5.2 years (range 2–9 years). At follow-up: (1) all patients except two in the control group received a diagnosis of bipolar disorder. (2) Fifteen patients had had more than one episode of mood disorder. (3) The two groups did not differ in social functioning nor school achievement. (4) Impact on school achievement was related to the severity of the mood disorder rather than ECT treatment. The results suggest that adolescents given ECT for bipolar disorder, depressed or manic, do not differ in subsequent school and social functioning from carefully matched controls.
Catatonia is a well-defined motor syndrome. Its prevalence has been found between 9.5 and 13.6% in various emergency psychiatric units.
A prospective evaluation was conducted for every patient admitted in the psychiatric emergency facility of the police authority in Paris (Infirmerie Psychiatrique près la Préfecture de Police) during 30 days. Catatonic symptoms were collected, as well as other clinical variables, by using a check-list adapted from DSM-IV criteria.
Catatonic and non catatonic patients were compared using khi2 for categorical variables and ANOVA for continuous variables. Variables which were statistically different between the two groups were entered in a step-wise logistic regression model (level of entry: .05).
The number of patients included was 229. A full catatonic syndrome (i.e. at least two prominent catatonic symptoms lasting for at least 24 hours) was found in 30 patients (13.1%). Main diagnoses in these patients were: schizophrenic disorders (24), bipolar disorders (4) and acute alcohol/street drugs intoxications (2). Ten out of 30 catatonic patients were not meeting anymore the diagnostic criteria for a catatonic syndrome at the end of the 24-48 hours observation and treatment time. Clinical characteristics of patients who were catatonic at entry, and those of patients who remained catatonic at the end of their admission are described and discussed.
Catatonia was frequent (13.1%), and 8.7% of the sample still presented a catatonic syndrome at the end of 24-48 hours of treatment.
To evaluate the safety of phosphatidylserine (PS) enriched with omega3 fatty acids, mainly eicosapentaenoic (PS-Omega3) in children with attention-deficit hyperactivity disorder (ADHD).
Two hundred children diagnosed with ADHD were randomised to receive either PS-Omega3 (300 mg PS-Omega3/day) or placebo for 15 weeks. One hundred and fifty children continued into an open-label extension for an additional 15 weeks in which they all consumed PS-Omega3 (150 mg PS-Omega3/day). Standard blood biochemical and haematological safety parameters, blood pressure, heart rate, weight and height were evaluated. Adverse events and the Side Effect Rating Scale were also assessed.
One hundred and sixty-two participants completed the double-blind phase. No significant differences were noted between the two study groups in any of the safety parameters evaluated. One hundred and forty participants completed the open-label phase. At the end of this phase, no significant changes from baseline were observed in any of the studied parameters among participants who consumed PS-Omega3 for 30 weeks.
Study results demonstrate that consumption of PS-Omega3 by children with ADHD, as indicated in a 30-week evaluation period, is safe and well tolerated, without any negative effect on body weight or growth.
To study the efficacy and safety of phosphatidylserine (PS) containing Omega3 long-chain polyunsaturated fatty acids attached to its backbone (PS-Omega3) in reducing attention-deficit/ hyperactivity disorder (ADHD) symptoms in children.
A 15-week, double-blind, placebo-controlled phase followed by an open-label extension of additional 15 weeks. Two hundred ADHD children were randomized to receive either PS-Omega3 or placebo, out of them, 150 children continued into the extension. Efficacy was assessed using Conners’ parent and teacher rating scales (CRS-P,T), Strengths and Difficulties Questionnaire (SDQ), and Child Health Questionnaire (CHQ). Safety evaluation included adverse events monitoring.
The key finding of the double-blind phase was the significant reduction in the Global:Restless/impulsive subscale of CRS-P and the significant improvement in Parent impact-emotional (PE) subscale of the CHQ, both in the PS-Omega3 group. Exploratory subgroup analysis of children with a more pronounced hyperactive/impulsive behavior, as well as mood and behavior-dysregulation, revealed a significant reduction in the ADHD-Index and hyperactive components. Data from the open-label extension indicated sustained efficacy for children who continued to receive PS-Omega3. Children that switched to PS-Omega3 treatment from placebo showed a significant reduction in subscales scores of both CRS-P and the CRS-T, as compare to baseline scores. The treatment was well tolerated.
The results of this 30-week study suggest that PS-Omega3 may reduce ADHD symptoms in children. Preliminary analysis suggests that this treatment may be especially effective in a subgroup of hyperactive-impulsive, emotionally and behaviorally-dysregulated ADHD children.