Many autistic children experience difficulties in their communication and language skills development, with consequences for social development into adulthood, often resulting in challenges over the life-course and high economic impacts for individuals, families, and society. The Preschool Autism Communication Trial (PACT) intervention is effective in terms of improved social communication and some secondary outcomes. A previously published within-trial economic analysis found that results at 13 months did not support its cost-effectiveness. We modeled cost-effectiveness over 6 years and across four European countries.

Using simulation modeling, we built on economic analyses in the original trial, exploring longer-term cost-effectiveness at 6 years (in England). We adapted our model to undertake an economic analysis of PACT in Ireland, Italy, and Spain. Data on resource use were taken from the original trial and a more recent Irish observational study.

PACT is cost-saving over time from a societal perspective, even though we confirmed that, at 13 months post-delivery, PACT is more expensive than usual treatment (across all countries) when given to preschool autistic children. After 6 years, we found that PACT has lower costs than usual treatment in terms of unpaid care provided by parents (in all countries). Also, if we consider only out-of-pocket expenses from an Irish study, PACT costs less than usual treatment.

PACT may be recommended as a cost-saving early intervention for families with an autistic child.

To evaluate the safety and efficacy of pregabalin in relieving the symptoms of GAD in patients ≥65 years of age.

This was a multicenter, randomized, flexible-dose, placebo-controlled, double-blind, parallel-group trial of pregabalin in the treatment of GAD. Randomization was 2:1, pregabalin:placebo. Patients underwent an 8-week double-blind, flexible-dosage (150-600 mg/d) treatment phase, including a 1-week dose-escalation period (50 mg/d to 150 mg/d). The primary efficacy assessment was change from baseline to endpoint-LOCF in HAM-A total score. Additionally, change from baseline to week 8 (observed cases) in HAM-A psychic and somatic factors was evaluated.

Mean age at GAD onset was 56 years; 77% of patients were women; mean age at enrollment was 72 years; mean duration of GAD was 17 years. Mean change from baseline in HAM-A total score was –12.84 (n=177) for the pregabalin group and –10.7 (n=96) for the placebo group (P=.0437). At week 8, patients treated with pregabalin had significant improvement in both the HAM-A psychic (–7.8 vs –6.3, P=.0111) and somatic (–6.6 vs –5.4, P=.0248) factors. The most common adverse events (AEs) among pregabalin-treated patients were dizziness (20.3%), somnolence (13.0%), headache (10.2%), and nausea (9.0%). Most AEs were mild-to-moderate and self-limiting. Discontinuation rates due to AEs were 10.7% and 9.4% in the pregabalin and placebo groups, respectively.

Pregabalin was effective in reducing the symptoms of GAD in patients aged 65 years and older, and it was safe and well tolerated in this population.

It is well known that students have several stressful situations to cope with and their coping strategies are of a wide range (Brougham et al., 2009, Zi et al., 2011, Pierceall and Cane, 2009).

The purpose of the study was to investigate how students coped with various stressful situations they faced.

One hundred participants, 60 men and 40 women, studying at TEI of Patras, Greece, were randomly selected and asked to describe their stressful situations and the ways they dealt with them.

The questionnaire used was based on “Échelle Toulousaine de Coping” (Tap et al., 1993) adjusted by Theodoratou et al. (2006).

Forty-five percent of the students could not control their feelings, while facing a difficult situation and might feel panic, but the majority of the students (63%) did not use medication to cope with a difficult situation. When facing a problem, the 45% of the students did not amuse themselves and 35% of the participants avoided communication with other people when they faced a problem. Moreover, 29% of the students chose to pray to face a difficult situation. Finally, 58% of the participants estimated that a counseling center in TEI of Western Greece would be necessary.

In conclusion, many students were overwhelmed by a negative emotion and most of them chose social withdrawal. Thus, they might feel helpless and suggested that a counseling center in their College and university might help them to overcome difficulties during their studies.

The authors have not supplied their declaration of competing interest.

Gender identity disorder is an emergent and important disorder which may lead to devastating consequences and comorbidities if proper treatment approaches are not used.

We planned showing the improvements in patients’ life in multilple domains after sex reassignment surgery (SRS).

In our research we focused on changes experienced by people who gained new gender identity with sex reassignment surgery.

We interviewed at least one year after the operation with 20 sex reassigned transsexuals (SR-T) who were once on SRS programme of Istanbul University Psychiatry Department Psychoneurosis and Psychotherapy Unit and who had confirmative rapports for surgery and we also interviewed with 50 non-sex reassigned transsexuals (NSR-T) who applied to the same unit for SRS programme.

Worries about gender discrimination and gender victimization were lower, but worries of being uncovered about transgender identity were higher in SR-T group. SR-T group scored lower on Family Assessment Device, 4th and 5th items of Arizona Sexual Life Scale and total points excluding the 3rd item (item for penile erection and vaginal lubrication), but scored higher on Multi Dimensional Scale for Perceived Social Support, Coopersmith Self Esteem Scale and psychological subscale of World Health Organization Quality of Life Scale-Brief Form.

The SRS used in the treatment of transsexuality releases the conflict and makes the transformation on official gender and is associated with improvements in quality of life, self esteem, family support, sexual life satisfaction and interpersonal reliationships and reduction in worries about gender discrimination and gender victimization.

Anxious-depressive disorders are common among children with epilepsy. A recent Systematic Review and Meta-Analysis (Scott et al., 2020) reported that the overall pooled prevalence of anxiety disorders is 18.9% while of depressive disorders is 13.5%. COVID-19 pandemic has centralized the attention of governors and careers on the health emergency. As a result, the trajectory of the psychological care needs of this at risk population may have been neglected.

The aim of the study was to assess the prevalence rate of depressive and anxiety symptoms among children with epilepsy during COVID-19 pandemic. Children were hospitalized in- and out-patients under a neurological and psychological follow up program in an Italian Children Hospital.

We conducted a cross-sectional study among 38 hospitalized children and adolescents with epilepsy (21F; 17M, mean age: 14,5; range: 11-18) during COVID-19 pandemic. We performed face-to face interviews and assessed depressive and anxiety symptoms with the Patient Health Questionnaire (PHQ-9) and the Generalized Anxiety Disorders (GAD-7) questionnaire during scheduled follow up checks.

Preliminary results showed a rate of mild-to-severe anxious depressive symptoms by 49.9% and 60.5% respectively. In detail: 21.1% mild, 15.7% moderate and 13.1% of severe anxiety, meanwhile 23.7% mild, 26.3% moderate and 10.5% of severe depression. The prevalence of comorbid depressive and anxiety symptoms was 39.5% among the entire sample.

Depressive and anxiety rates among hospitalized children with epilepsy during COVID-19 outbreak are very high. Pediatric services should deserve special attention to those patients’ mental health. Regular screening protocols and empowerment interventions in Hospital should be promoted.

No significant relationships.

Adherence to treatment of mental disorders is one of the key factors influencing its success and, secondarily, the patients’ quality of life and social adaptation.

The cross-sectional study of 90 outpatients diagnosed with psychotic disorders aimed at determining if there was a relationship between discontinuation of medication in the past, current adherence to treatment and self-stigma.

The assessment was made with the objective and subjective Clinical Global Impression – Severity scale, Drug Attitude Inventory, Internalized Stigma of Mental Illness (ISMI) scale and demographic data.

The questionnaires were filled out by 79 patients, of whom 5 handed in incomplete questionnaires. Complete sets of data were obtained from 74 patients. The data analysis showed that the levels of self-stigma as assessed by the total ISMI scores was not statistically significantly correlated with most of the demographic factors (age, age of illness onset, gender, education, marital status, employment, duration of the illness, number of hospitalizations and antipsychotic dosage). However, there was a significant negative correlation with current adherence to treatment.

Adherence to treatment is one of the most important prerequisites for successful therapy. Adherence may be enhanced through better motivation and education of patients on the necessity of adhering to treatment recommendations and the consequences of non-adherent behavior. Important factors in adherence also seem to be patients’ stigmatization and self-stigma. Adherence may be increased by promising self-stigma-reducing strategies performed by systematic psychoeducation of patients or as a part of psychotherapeutic counseling.

The authors have not supplied their declaration of competing interest.

Two randomized, controlled trials of L-methylfolate augmentation of SSRIs for major depressive disorder (MDD) were conducted using a novel study design (sequential parallel comparison design- SPCD).

To evaluate the efficacy of L-methylfolate augmentation using the Hamilton Depression Rating Scale.

In study one (TRD-1), 148 outpatients with SSRI-resistant MDD were enrolled in a 60-day, SPCD study, divided into two 30-day periods (phases 1 and 2). Patients were randomized 2:3:3 to receive L-methylfolate (7.5mg/d in phase 1, 15mg/d in phase 2), placebo in phase 1 followed by L-methylfolate 7.5mg/d in phase 2, or placebo for both phases. Study two (TRD-2) involved 75 patients and was identical in design to TRD-1 except for the dose of L-methylfolate (15mg only).

In the TRD-1 Study, L-methylfolate 7.5 mg/d was not found to be more effective than placebo. In phase 1 of the TRD-2 Study, 37% of patients on L-methylfolate 15mg/d responded and 18% of placebo patients responded, while in phase 2 among placebo non-responders, the response rates were 28% on L-methylfolate 15mg/d and 9.5% on placebo. When phases 1 and 2 were pooled according to the SPCD model, the difference in response rates was statistically significant in favor of L-methylfolate (p = 0.0399). The rates of spontaneously reported AEs and rates of study discontinuation appear r comparable between L-methylfolate and placebo in both studies. Rates of study discontinuation were also comparable

These studies suggest that L-methylfolate 15 mg/d may be a safe and effective augmentation strategy for inadequate response to SSRIs.

To assess whether therapy with two widely used antidepressants influences platelet counts.

In 90 patients hospitalized for treatment of a major depressive episode according to DSM-IV, platelet counts were performed after a 6 d antidepressant-free run-in period and again after 35 d of active standardized treatment with amitriptyline (n = 40) or paroxetine (n = 50).

There was a trend for platelet counts to increase during treatment with amitriptyline (from 245.5 ± 68.6 to 256.8 ± 69 cells × 109 L-1, P < 0.06); no change was observed during treatment with paroxetine (from 232.6 ± 58.3 to 234.6 ± 68.9 cells × 109 L-1, n.s).

Treatment with amitriptyline tends to be associated with elevated platelet counts. The cause for this increase is not known, but may be relevant in terms of patients’ long-term thromboembolic risk.

F17464 is a new highly potent preferential D3 antagonist, 5-HT1A and weak D2 partial agonist, with confirmed antipsychotic-like activity in animal models. In healthy volunteers, F17464 had a good safety and tolerability profile. A PET-scan study determined a high D3 occupancy rate up to 22 h after a single dose.

The primary objective was to evaluate the efficacy of 40 mg/day of oral F17464 in comparison to placebo.

This double-blind, parallel group, multicenter study included patients with acute exacerbation of schizophrenia treated for 6 weeks as antipsychotic monotherapy. Patients were hospitalised for the first 3 weeks of treatment, then continued as outpatients.

The 144 randomized patients had a baseline PANSS mean (SD) total score was 89.6 (9.5). The change from baseline of PANSS total score to Day 43 on the FAS (LOCF), showed a statistically significant difference in favor of F17464 over placebo: adjusted mean (SE) change −13.5 (2.1) on F17464 and −7.8 (2.2) on placebo with a treatment effect estimate −5.7 (2.7). The 20% or 30% response rate was statistically higher in the F17464 group (47.2% and 25.0%) compared to the placebo group (30.6% and 13.9%). The incidence of treatment-emergent adverse events was slightly higher in the F17464 group (70.8%) than in the placebo group (62.5%). There were no clinically-relevant hepatic, metabolic, or cardiovascular abnormalities. No EPS was reported under F17464.

This is the first D3 antagonist that proves efficacy. The results of this phase 2 study also demonstrate the favorable safety profile of F17674 when compared to placebo.

The authors have not supplied their declaration of competing interest.

Cognitive impairment in patients with depressive disorder is a subject of intensive research.

This study deals with the cognitive impairment in patients with severe depressive episode with psychotic symptoms and patients with major depressive disorder during the acute state of illness.

The aim was to define domains and the level of cognitive impairment in both groups of patients.

The next aim was to compare profiles of cognitive impairment in both groups of patients.

The last aim was to find out a relationship between cognitive performance and severity of depressive episode during the acute state of illness.

We have used neuropsychological test battery (Auditory–Verbal Learning Test, Rey-Osterrieth Complex Figure Test, Logical Memory, Digit span test, Trail making test, Verbal Fluency Test, Block Design and Benton Visual Retention Test) for the evaluation of the cognitive functions in patients with severe depressive episode with psychotic symptoms (n = 5) and patients with major depressive disorder (n = 8).

We found cognitive impairment in all examined domains in both groups of patients.

More profound cognitive impairment was found in patients with severe depressive episode with psychotic symptoms, particularly in visual memory, visuo-constructive abilities, speed of cognitive processing and executive functions. We found no correlation between cognitive performance and severity of depressive episodes.

Our findings suggest a strong correlation between psychotic symptoms in depression and cognitive performance.

to examine the longitudinal effect of depression on glycemic control in a sample of patients with type 2 diabetes.

the patients were recruited from diabetes clinic in Saudi airlines medical center, in Jeddah, the base line study community consisted from 172 patients with type 2 diabetes. They were assessed for depression using BDI II, and diagnostic interview, and for diabetic control using HbA1c. We created a person-period data set for each patient to cover 6 months intervals up to 3 years. We used generalized estimation equation (GEE) for analysis of longitudinal data. HbA1C was the response variable while depression and time were the main covariates. Variables were included in GEE models based on clinical importance and preliminary analysis. Other variables included as covariates were gender, education, duration of diabetes, co-morbidity and LDL. All statistical analysis used α = 0.05 level of significance and were performed using SPSS software version 21.

Unadjusted HbA1c means were significantly higher in depressed vs. non-depressed subjects at all time points. The adjusted HbA1c means in final GEE model were significantly higher in depressed vs. non-depressed subjects. In all adjusted models depression was a predictor of glycemic control weather it was BDI score (estimate = .049, P = .002), diagnoses of MDD (estimate = 2.038, P = .000), or other depressive diagnosis (estimate = 1.245, P = .000).

This study on clinical sample of type 2 diabetic patients demonstrates that there is a significant longitudinal relationship between depression and glycemic control and that depression is associated with persistently higher HbA1c over time.

The authors have not supplied their declaration of competing interest.

Because randomized clinical trials in bipolar disorder include restricted study populations, the possibilities for generalizing to real-world bipolar patients are limited. Naturalistic long-term data can add valuable information about the diversity of treatment, outcome and risk factors in bipolar disorder.

After discharge from a psychiatric community hospital, 300 consecutively admitted ICD-10 bipolar I (n=158) and II (n=142) patients were followed-up naturalistically during for 4 years. Patients were assessed as to time to relapse, relapse in relation to index episode, prophylactic effects of prescribed medication, and risk factors for relapses such as prescribing attitudes, medication adherence, life events and alcohol use disorders.

204 (68%) of 300 patients relapsed within 4 years, with a mean of 208 days (SD=356.2) until the next affective episode. Relapses correlated in a statistically significant manner with the index episode. Using a Kaplan survival analysis, only lithium delayed time to the next affective relapse in a statistically significant way. Survival was reduced in a statistically significant manner when prophylactic medication was replaced by the psychiatrist or stopped by the patient. In a sub-analysis of this cohort life events (n=222) and alcohol use disorders (n=284) were associated with more depressive episodes in bipolar I patients.

Even though lithium seems more protective than other commonly used drugs, bipolar patients still suffer from a high relapse rate. Bad adherence, life events and alcohol use disorders are hereby major risk factors. The results urge for further and more holistic treatment approaches in bipolar disorder.