The glucagon-like peptide-1 (GLP-1) receptor agonist Semaglutide has been widely used to manage type 2 diabetes due to its favourable effects on glycemic control and weight reduction. Proved to be safe in adults and elderly patients with renal or hepatic disorders demanding no dose modification. Affective symptoms are not listed as side effects in the product information. However, there is a recent investigation going on by the European Medicines Agency (EMA) after three flagged cases of suicidal thoughts in Iceland. In contrast, the Food and Drug Administration (FDA) recommend that patients with this treatment are monitored for suicidal thoughts or behaviour.

This case study explores the possible relationship between Semaglutide treatment and the onset of a manic episode in a 57-year-old male with no history of psychiatric disorders.

We present a 57-year-old male with no psychiatric history of interests, with a previous good functioning. A one-week history of disruptive behaviours started, characterized by excessive cheerfulness, heightened euphoria, and reduced need for sleep. Family members describe a complex situation at home, with frequent outings by the patient, engaging in conversations with strangers, getting lost, and becoming more irritable with them. The patient and family relate this mood change after initiating Semaglutide for diabetes control, starting at 7mg doses. The temporal relationship between the initiation of Semaglutide therapy, precisely a dose escalation to 7mg, and the onset of manic symptoms prompted family members to notify the patient’s endocrinologist. Due to the inability to manage the patient at home and his unpredictability, they sought help at the emergency department, resulting in a psychiatric admission. Imaging and analytical tests show no significant abnormalities.

During his stay in the psychiatry department, semaglutide dosage was reduced, and treatment with Aripiprazole was initiated at doses of 5mg, given the metabolic profile associated with medical comorbidities (obesity, chronic renal failure and diabetes). Subsequent clinical observations showed a gradual resolution of manic symptoms and an improvement in the patient’s overall mental state.

This case highlights the importance of monitoring and recognizing potential neuropsychiatric side effects associated with Semaglutide therapy, particularly in individuals without a prior psychiatric history. Further research is warranted to elucidate the underlying mechanisms linking Semaglutide with mood disturbances and to identify risk factors that may predispose certain patients to develop manic states in response to this GLP-1RA. Clinicians should remain vigilant and consider alternative treatment options if such side effects occur, ensuring comprehensive management of patients receiving Semaglutide for diabetes control.

None Declared

The trans-3;4-dichloro-N-(2-(dimethylamine) cyclohexyl) labelled as U-47700 has a high affinity with the selective receptor, considered to have 7.5 times the binding affinity of morphine; as a result, it is sold as a recreational drug because of its analgesic and euphoric effects. Several toxicity cases and some fatalities have been reported during 2016.

To describe the presence of trans-3;4-dichloro-N-(2-(dimethylamine) cyclohexyl) in samples delivered to Energy Control during 2016 in Barcelona.

From January 2016 to October 2016, 4031 samples were delivered and only those samples containing trans-3;4-dichloro-N-(2-(dimethylamine) cyclohexyl) were studied, 6 of them were analysed as U-47700 (0.148%). Samples were analysed by energy control, a Spanish harm-reduction NGO that offers users the possibility of analysing the substances they intend to consume. Analysis was done by gas chromatography–mass spectrometry.

From the 6 samples that were analysed as trans-3;4-dichloro-N-(2-(dimethylamine) cyclohexyl), the presentation of 4 of them was white powder and the rest were not described. The procedence of the samples was Canada (2), USA (1), Sweden (1), Holland (1) and the remaining sample was not described. All samples were received during 2016.

The use of trans-3;4-dichloro-N-(2-(dimethylamine)cyclohexyl) is progressively increasing in Barcelona. Its harmful effects are being reported in recent medical literature and consumption represents an emerging issue, gaining popularity among recreational opioid users. It is potentially lethal when mixed with depressants like alcohol or benzodiazepines and overdose risk is higher compared to other opioids. This drug is not being detected by routine in medical test.

The authors have not supplied their declaration of competing interest.

Serotonin syndrome is a potentially life-threatening condition that is precipitated by the use of serotonergic medications, Selective Serotonin Reuptake Inhibitors (SSRIs) and Monoamine Oxidase Inhibitors (MAOIs). It usually occurs when high doses of serotonergic drugs are prescribed. It is a medical emergency that requires prompt recognition, cessation of offending drugs and supportive therapy.

We present a case of serotonin syndrome that occurred in a patient who was prescribed a low dose of sertraline, and aim to highlight the importance of early detection of this severe condition.

Details of the case were described. Information was gathered based on medical records.

Patient M was a 29-year-old Malay male with a history of major depressive disorder, who was previously trialed on fluvoxamine 100mg every night but subsequently switched to and maintained on sertraline 75mg every night in 2020. He then defaulted follow up appointments. In 2023, he presented to the emergency services for a suicide attempt and was diagnosed with major depressive disorder with psychotic features. He was restarted on sertraline 50mg every night and risperidone 0.5mg every night was newly started. Two days later, sertraline was increased to 100mg every night. Two days following this increase, he was noted to have altered mental state, fever of 39.3-degree celcius, tachycardia of 120 beats per minute, ocular clonus and generalized hyperreflexia. Sertraline and risperidone were immediately stopped. Blood tests including creatine kinase, lumbar puncture and magnetic resonance imaging (MRI) of the brain did not show any abnormalities. After stopping of the medications, the patient’s symptoms resolved within 24 hours. Based on clinical symptoms and a normal creatine kinase level, neuroleptic malignant syndrome (NMS) was ruled out. Subsequently, he was restarted on risperidone 0.5mg and mirtazapine 7.5mg every night. He developed symptoms of serotonin syndrome with a low dose of sertraline. Symptoms resolved after the discontinuation of the SSRI.

In this case, differential diagnoses of serotonin syndrome were also considered, such as NMS, encephalitis, meningitis and thyroid storm. NMS was less likely due to the rapid onset of onset and resolution of symptoms. Encephalitis and meningitis were unlikely in view of normal MRI brain and lumbar puncture findings.

There have been case reports of serotonin syndrome developing with lower doses of an SSRI in the pediatric population. There is, however, a lack of literature describing serotonin syndrome with low doses of SSRI in the adult population. To avoid a missed diagnosis, clinicians should monitor closely for SSRI toxicity, including serotonin syndrome, even when low doses of serotonergic drugs are used.

None Declared

Early childhood aggressive behaviour is a predictor of future violence. Therefore, identifying risk factors for children’s aggressive behaviour is important in understanding underlying mechanisms. Maternal postpartum depression is a known risk factor. However, little research has focused on the influence of paternal behaviour on early childhood aggression and its interaction with maternal postpartum depression.

This study was performed in two cohorts: the Fathers Project, in the United Kingdom (n = 143) and the Generation R Study, in The Netherlands (n = 549). In both cohorts, we related paternal antisocial personality (ASP) traits and maternal postpartum depressive (PPD) symptoms to childhood aggressive behaviour at age two (Fathers Project) and age three (Generation R Study). We additionally tested whether the presence of paternal ASP traits increased the association between maternal PPD–symptoms and early childhood aggression.

The association between paternal ASP traits and early childhood aggressive behaviour, corrected for maternal PPD-symptoms, was similar in magnitude between the cohorts (Fathers Project: standardized β = 0.12, p = 0.146; Generation R: β = 0.14, p = 0.001), although the association was not statistically significant in the Fathers Project. Strikingly, and in contrast to our expectations, there was evidence of a negative interaction between paternal ASP traits and maternal PPD-symptoms on childhood aggressive behaviour (Fathers Project: β = −0.20, p = 0.020; Generation R: β = −0.09, p = 0.043) in both studies. This meant that with higher levels of paternal ASP traits the association between maternal PPD-symptoms and childhood aggressive behaviour was less and vice versa.

Our findings stress the importance of including both maternal and paternal psychopathology in future studies and interventions focusing on early childhood aggressive behaviour.

A bidirectional association between type 2 diabetes and depression has been consistently reported. It is associated with worse biomedical outcomes and increased mortality. One possible question is whether the co-occurrence of type 2 diabetes and depression is due to genetic and/or environmental vulnerabilities in common to the two traits.

To examine the genetic relationship between type 2 diabetes and depression at a population level.

To quantify the genetic overlap between type 2 diabetes and depression using the Swedish Twin Registry.

The study included 43,565 twin pairs (12,363 monozygotic pairs and 31,202 dizygotic pairs). The primary outcomes were lifetime diagnosis of type 2 diabetes and depression from the Swedish National Hospital Discharge Registry. Standard bivariate twin models were fitted to the raw data to estimate the genetic and environmental (co)variance of the two traits.

Heritability estimates for lifetime diagnoses of type 2 diabetes and depression were similar to previous estimates, at 77% and 42% respectively. The phenotypic correlation between type 2 diabetes and depression was 0.14 (95%CI: 0.11-0.17), of which 58% was due to shared genetic influences. When covariates (age and gender) were included, the genetic contribution to the phenotypic correlation reduced to 51%.

This is the first study to demonstrate a small but significant genetic overlap between type 2 diabetes and depression at a population level, using hospital-registry records.

While alcohol-induced psychotic disorder (AIPD) is a well-recognised clinical disorder, relativery little is known about aspects such as epidemiology, course and treatment of the condition. Current evidence suggests AIPD can be clinically distinguised from alcohol-withdrawal delirium and schizophrenia. AIPD is associated with high comorbidity with other psychiatric disorders, high re-hospitalization and mortality rate, namely suicidal behaviour.

The objetive of the study was to examine the correlates, clinical features, psycopathology, and short-term response in an inpatient sample with alcohol-induced psychotic disorder, predominant hallucinations (ICD-10 F10.52) admitted to Centro Hospitalar Psiquiátrico de Lisboa.

We collected retrospectively data from all admitted patients to our Alcohol Unit between January 2010 and January 2020 with the diagnosis of AIPD. The exclusion criteria were: presence of preexisting psychotic disorder, delirium, or other substance use disorders. We characterized our sample in Demographic categories, Clinical categories, Treatment and Short-term course.

A total of 113 subjects were included in the study. The prevalance of alcoholic hallucinosis was found to be 1.3% of all patients who received inpatient treatment. Most individuals reported auditory hallucinations, that iniciated when they decrease their alcohol intake, and 1 in 4 had past episodes of AIPD.

There are specific challenges in studiyng AIPD, such as the relatively rarity of the disorder, its often transient nature and high levels of comorbidity. A high degree of recurrence and morbidity indicates a need to prevent, and intervene early with an abstinent-oriented management goal.

No significant relationships.

The identification of potential biomarkers is crucial to improve the management and treatment of mood disorders. Glycogen synthase kinase-3 (GSK-3) is a multifunctional enzyme with an important role in the etiology of mood disorders. Recent findings suggested GSK-3 as a putative biomarker in mood disorders.

The aims of the study are: - to evaluate GSK3 as potential biomarker for differential diagnosis (MDD and BD); - to analyze the regulation of GSK3 by psychopharmacological treatments.

Patients included fulfill the following criteria: (a) principal diagnosis of MDD or BD (DSM-5); (b) age ≥ 18 years; (c) drug-free for at least 4 weeks before the inclusion. For each patient included a healthy control is enrolled, matched by gender and age. All included subjects at the study entry point (t0) are assessed through: - semistructured clinical interview and clinical rating scales (Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale; Young Mania Rating Scale, Clinical Global Impression) - blood draw, to measure GSK-3 levels Patients with MDD or BD are assessed again after 1 week (T1) and after 2 month (T2) of specific pharmacological treatment.

So far, we enrolled 16 patients and 16 healthy controls. The enrollment is still ongoing.

We expect to find GSK-3 levels differently expressed between healthy controls, patients with DDM and patients with BD. This finding would be crucial as it could contribute to the improvement of differential diagnosis. Moreover, we expect to observe a change in GSK-3 levels after psychopharmacological treatments.

Hair loss resulting from childhood irradiation for tinea capitis has been linked to mental health effects in women. However, the association of hair loss severity with mental health in this population is unknown.

The aim of this study is to examine the association between hair loss severity and mental health outcomes in women irradiated for tinea capitis in childhood and to identify contributing factors to these outcomes.

Medical records, held at the archives of Israel National Center for Compensation of Scalp Ringworm Victims, were retrospectively reviewed for 2509 women who received compensation for full or partial alopecia resulting from irradiation in childhood for tinea capitis. Mental health outcomes were determined by the number of mental health conditions reported.

Among women with high hair loss levels, risk was increased for a range of mental health problems, including depression symptoms, emotional distress, social anxiety, low self-esteem, and suicidal ideation. Hair loss severity emerged as a significant predictor of mental health, adding to the effects of other predictors such as family, and social and physical health problems. Effects of hair loss severity on mental health outcomes were mediated by women’s negative social experiences.

Hair loss severity is a significant risk factor for mental health problems in women irradiated for tinea capitis in childhood. Further research is needed to assess mental health risks among women with severe hair loss associated with additional diseases.

No significant relationships.

Researches has shown that a subset of the autism spectrum disorder (ASD) population presents with immune dysregulation. Based upon the immunological abnormalities, various treatment modalities have been applied to children with ASD. One immunomodulatory treatment that has been studied in ASD is intravenous immunoglobulins (IVIG).

This report is based upon two hypotheses: autism etiology may be closely related to neuroinflammation; and, an effective treatment should restore the individual’s comminication skills. In this report, we present two cases who were diagnosed with ASD and received IVIG treatment.

Case A is a 5-year-old female patient who was diagnosed with ASD at the age of 3. The second case, B is a 9 -year-old male patient who is a 7th grade student and was also diagnosed with ASD at the age of 3. The first patient’s autism symptoms was noticed by her family at the age of 2. Although she had the ability to coordinate eye contact, understood simple commands, she was observed to lose all her acquired developmental skills one by one at around 18-24 months. Towards the age of 3, stereotypical movements such as turning around and flapping wings, started. Similarly, the second patient’s acquired skills were lost around at the age of 2-3, after having recurrent infections. Based on deficits in social‐emotional reciprocity, deficits in nonverbal communicative behaviors used for social interaction and restricted/repetitive patterns of behavior, both patients were diagnosed with ASD. Considering that autoimmune mechanisms may have been affected in ASD, IVIG treatment was initiated at 1 g/kg/month. Case A received IVIG once in a month, total 5 infusions had been applied. Case B received total 12 infusions with the same protocol. Treatment response was assessed with the Childhood Autism Rating Scale (CARS).

In these two ASD cases which were treated with IVIG ,a subjective partial reduction in autism symptoms and an objective decrease in CARS scores were detected. Current evidence suggests that there are various factors contributing to the development of autism and different combinations of these aspects give rise to different variations of some ASD subtypes. Recent studies in this field indicate a possible connection between the immune system impairments and ASD. This report, therefore, provide support for the notion that at least a subset of children with ASD might have immune abnormalities and may respond to the immune modulating effect of IVIG therapy.

Although, autoimmune or inflammatory etiologies may not explain the majority of cases of autism, it might at least be useful to understand some. Further studies with larger number of patients should be conducted about the use of IVIG in selected patients with ASD.

None Declared

Lack of insight in schizophrenia is frequently associated with deficits in self-assessment of cognitive and functional abilities, as well as quality of life outcomes.

The aim of this analysis was to evaluate the impact of treatment-related improvement in illness awareness on changes in cognition and functional outcomes in a double-blind, controlled study.

Clinically unstable patients with schizophrenia (N=488) were randomized to once-daily, fixed dose treatment with lurasidone 80 mg (LUR 80), lurasidone 160 mg (LUR 160), quetiapine XR 600 mg (QXR) or placebo (PBO), followed by a 12-month, double-blind extension. Impairment of insight (G12 ‘lack of judgment and insight’), cognitive performance, quality of well-being (QWB scale), and UPSA-B were assessed at baseline, week-6 and month-6 of extension (32 weeks). Mixed effects model was applied.

PANSS insight scores were significantly improved for all treatment groups compared to placebo after 6 weeks. Improvement in insight at week-32 was significantly greater in subjects treated with lurasidone compared with quetiapine XR. Improved insight at week-6 was a significant mediator for the effect of LUR160 (vs. placebo) on neurocognitive composite score (p<0.05), UPSA-B total score (p<0.05), and QWB (p<0.05) at week-6. Improved insight was significantly associated with increase in UPSA-B score and health-related quality of life at weeks 19 and 32.

Improvement in insight at week-32 was significantly greater in subjects treated with lurasidone compared with quetiapine XR. Our findings suggest treatment-related improvement in illness awareness had significant impact on cognition and functional outcomes in a doubleblind, controlled study.

Persons receiving care in forensic settings face unique challenges. Long hospital stay combined with other factors such as reduced physical activity, unhealthy diets, smoking, serious mental illness, antipsychotic medications, all add up to increase their risk of acquiring metabolic syndrome, thereby increasing morbidity and mortality.

Practice of monitoring for metabolic effects of an atypical antipsychotic- Clozapine was audited with the Maudsley Guideline as standard in 2 medium secure wards with 25 patients. It was conducted in 2011.

We checked whether blood lipids and body weight were monitored at baseline, at 3 months and then yearly; whether blood glucose and blood pressure were checked at baseline, at 4–6 months and then yearly.

Various sources of information were used including: paper medical records, electronic clinical entries, physical observation charts, medication prescription charts, Clozapine charts and acute hospital laboratory results

24 patients (96%) were on antipsychotic medication. Of these, 23 patients were on atypicals. Of the latter, 8 persons were on Clozapine. No patient on Clozapine achieved a 100% monitoring on indices. Baseline monitoring for cholesterol, weight, blood glucose and blood pressure were 88%, 50%, 75% and 88% respectively. At midterm they were 50%, 100%, 38%, and 25% respectively. There were variable compliance with other indices at stipulated times. Lack of supporting infrastructure to facilitate compliance was identified.

There was a need to adhere to existing guidelines which were also embodied in Trust policy to help manage metabolic syndrome.

Parkinson disease is a frequent neurodegenerative disorder. Presence of psychopathology is well described in this illness, nevertheless the etiology is still unknown.

The authors present a clinical case of a patient with idiopathic Parkinson disease with depressive symptoms after the decline of his functioning. We aim to emphasize the importance of a multidisciplinary approach and the central role of general physicians in screening these situations.

The patient is a male with 64 years old, reformed with a personal history of hypertension. With 62 years old he started with mild motor complaints that got worse over time, culminating after a year and half on him being almost dependant for most of his daily activities. He also started to express feelings of sadness, despair, and recurrent thoughts of death. He refused to seek out medical help, but was convinced by his wife to consult his general physician that observed the patient and referenced him to Neurology and Psychiatry consultations. He also started sertraline 50 mg/day. He was diagnosed with Parkinson disease and started medication with ropinirole, levodopa and carbidopa with a good response. In Psychiatry consultation the dose of sertraline was increased to 100 mg/day with improvement, and it was provided information on the disease to the patient and family and also supportive psychotherapy.

General physicians have a privileged position on screening patients with psychopathology when other physical conditions or illnesses are present. The fast and correct referencing of these patients can improve the prognosis.

The authors have not supplied their declaration of competing interest.

We recruited n=15 SAD subjects and n=11 NC. We have utilized TMS on Primary Motor Cortex (M1) in order to study neuronal excitability and cortical inhibitory mechanisms. These has been achieved by examining EMG recording Motor Evoked Potentials (MEP). We measured MEP, Motor threshold, Cortical Silent Period (CSP), paired pulse inhibition both in patients and healthy controls. Clinical assessment was conducted with the MINI interview, Liebowitz Social Phobia Scale, TPQ

neurophysiological variables are not significantly different between groups. Patients with SAD showed a significantly higher Harm Avoidance and lower Novelty Seeking. There was a positive correlation between CSP and Novelty seeking and a negative correlation between LICI and Novelty Seeking among patients but not among HCs

A comparison between Pyridoxine (vitamin B6) and a placebo for the treatment of premenstrual syndrome (PMS).

A double blind randomized clinical trial was performed on 160 university students who were suffering from PMS (according to the retrospective diagnostic criteria which had been recorded during the last 3 menstrual cycles). Then the patients were randomly assigned into two groups, and finally 94 patients who had finished the study were statistically analyzed.

In the Pyridoxine group (46 patients) vitamin B6 was prescribed at a dose of 40 mg twice daily (total 80 mg), and in the placebo group (48 patients) a tablet similar to vitamin B6 tablets in size, smell, shape and taste was prescribed 1 tablet twice daily. In both groups the tablets were started from the first day of the fourth menstrual cycle and continued for the next two cycles, and during these two cycles the symptoms were recorded.

The severity of PMS in the second cycle of the treatment (in both groups) showed a statistically significant decrease (p <0.05, Pair T test) and the comparison between the two groups showed that the severity of PMS in the Pyridoxine group decreased more than the placebo group, which was statistically significant (p < 0.05, Student T Test) and this was because of the reduction in the psychiatric rather than somatic symptoms of PMS.

Regarding the effect of Pyridoxine in reducing the severity of PMS, it can be suggested as a treatment for PMS.

The growing concern about cannabis use, the most used illicit drug worldwide, has led to an increase in the number of cannabis studies using neuroimaging techniques to determine its effect on brain structure and function.

We conducted a systematic review to assess the evidence of the impact of chronic cannabis use on brain structure and function in adults and adolescents.

Papers published until August 2012 were included from EMBASE, Medline, PubMed and LILACS databases following a comprehensive search strategy and pre-determined set of criteria for article selection. Only neuroimaging studies involving chronic cannabis users with a matched control group were considered.

One hundred and forty-two studies were identified, of which 43 met the established criteria. Eight studies were in adolescent population. Neuroimaging studies provide evidence of morphological brain alterations in both population groups, particularly in the medial temporal and frontal cortices, as well as the cerebellum. These effects may be related to the amount of cannabis exposure. Functional neuroimaging studies suggest different patterns of resting global and brain activity during the performance of several cognitive tasks also in both groups, which may indicate compensatory effects in response to chronic cannabis exposure. The results pointed out methodological limitations among studies and high heterogeneity in the findings.

Chronic cannabis use may alter brain structure and function in adult and adolescent population. Further studies should consider the use of convergent and multimodal methodology, prospective large samples involving adolescent to adulthood subjects, and data-sharing initiatives. Grants: PNSD/2011/050, PNSD2006/101, SGR2009/1435.

Joint hypermobility syndrome/Ehlers Danlos III (JHS/EDS III) is a common, connective tissue condition. This group is over-represented in panic/anxiety disorders and exhibits autonomic abnormalities and heightened interoceptive sensibility. Previous neuroimaging in healthy volunteers with hypermobility has observed differences in key emotional brain regions, notably amygdala and insula.

Aims and objective To explore, in a clinical population, the structural brain correlates underpinning the association between JHS/EDS III and anxiety.

Seventy participants were divided into four experimental groups: (2 × 2 factor design: presence/absence of hypermobility; presence/absence of anxiety). Hypermobility was assessed using Brighton Criteria. All participants underwent brief tests of autonomic function and interoception. Structural images were obtained using a 1.5 T MRI scanner. Results are reported at whole brain uncorrected significance threshold of P < 0.001.

Comparison of grey matter volume revealed increased insular volume in anxious patients with JHS/EDS-III compared to anxious patients without (Fig. 1A, B), correlating with initial peak heart rate on standing. Additionally, amygdala volume correlated with hypermobility score in anxious patients, but not in non-anxious individuals (Fig. 1C, D). Amygdala volume correlated with interoceptive accuracy.

This data implicates amygdala and insula as likely neural substrates mediating clinical relationships between hypermobility syndrome and anxiety, demonstrating the relevance of autonomic and interoceptive influences on this relationship. Further work hopes to explore functional and structural connectivity between these regions in JHS/EDS-III.

The authors have not supplied their declaration of competing interest.

Mental disorders are a major cause of disability in Europe [1]. However, organizational structures and information systems are focused on delivery of care, rather than providing value [2]. In the digital era, we have the capacity to change priorities through the analysis of heterogeneous databases that could support patients’ and professionals’ decisions.

to analyse the contradictions between the design and the theoretical structure of mental health services and the possibilities to evaluate the actual value of the delivered care.

To reflect on changing the trend using a different conceptualization of objectives and evaluating methods.

We used a tool provided to clinicians by the Madrid's Regional Health Service SERMAS (‘ConsultaWeb’) combining primary care, pharmacy and hospital data (n = 395,073 patients for the catchment area), and a set of hospital-based data (patients attended by psychiatrists at the ER, n = 13,877, and patients admitted to the Psychiatric Inpatient unit n = 3318), to explore some of the present professional information resources.

Currently used healthcare databases only describe the diagnostic or therapeutic categories of patients and might be used to detect abnormal behaviours. However, they are neither able to show the functional status of patients nor designed to predict their clinical course.

A clearer definition of value in patient outcomes is needed. This might help to organize the healthcare delivery and to create a new information system that would allow to asses health outcomes.

The authors have not supplied their declaration of competing interest.

To assess efficacy and safety of tenoten for children (TC, ultra-low doses of antibodies to S100 protein) in ADHD patients.

In a double-blind placebo-controlled study 50 children (6-12 years) met DSM-IV criteria, mild/moderate CGI-ADHD-Severity and ADHDRS-IV-Parent:Inv > 22 points were enrolled. Patients were randomized to receive either TC (2 tablets BID, n=25) or placebo (n=25) for 12 weeks. ADHD symptoms were assessed by ADHDRS-IV-Parent:Inv, CPRS-R:S and CGI-ADHD-Severity.

According to both parents and investigators assessment TC decreased ADHD symptoms: ADHDRS-IV total score reduced by 13.5 points, hyperactivity by 6.7 points, inattention by 6.8 points (5.4, 2.3 and 3.2 in placebo); CPRS-R:S total score reduced by 12.8 points, hyperactivity by 3.6 points, inattention by 6.1 points (4.8, 1.8 and 1.7 in placebo). ADHD severity reduced in 9 patients received TC and 3 patients received placebo. No adverse effects were reported in both groups.

The study demonstrated good clinical efficacy and safety of TC in children with ADHD.