In the Past, no regulations existed to protect the public from dangerous drugs. Medications that were ineffective, potentially harmful were sold to the public. This is a drastically different reality from what exists today in the United States and Europe.

The approval processes of the FDA and EMA are complex. It is a process difficult to understand for patients. It is information that Clinicians should be familiar with. What does the FDA or EMA approval processes actually entail? What does it mean?

To describe the FDA and EMA as well as their approval processes for new medications.

A review of the literature as published by the EMA, as well as the FDA Orange Book from 1995–2012 to compare the FDA and EMA central approval processes.

The public trust the FDA and EMA to determine what medications are safe and effective, making the FDA and EMA approval a meaningful title to patients. Review of the literature and medication approvals in EU and US shows two of the world's most rigorous drug review processes.

In an increasingly expanding environment of global healthcare, we attempt to stimulate discussion about the challenges of cross cultural medicine. Some of these challenges are elucidated by the drug approval process of the EMA that tries to incorporate all member nations of the E.U under one regulatory agency. This is a theme that will continue to emerge as we look at world in which information and medicine become intertwined.

OCD is a complex disorder with multiple aetiological theories. Recent research points to role of autoimmunity as well as hyperactivity of glutaminergic pathways in aetiopathogenesis of the disorder. It is possible that autoimmune mechanisms may modulate excitatory neurotransmission resulting in OCD.

This study aimed to study the association between serum anti-basal ganglia autoantibodies (ABGA) and Glx (glutamate + glutamine) levels in caudate nucleus and anterior cingulate cortex as demonstrated by 1H-MRS (proton magnetic resonance spectroscopy).

Thirty psychotropic-naive OCD patients and an equal number of age, gender matched healthy controls were studied using 1H-MRS and levels of Glx were obtained. ABGA was measured using ELISA (enzyme linked immunosorbent assay) technique and categorised as present or absent in the serum.

ABGA was present in significantly higher proportion of patients as compared to controls (P < 0.05). Glx level was significantly higher (as measured by 1H-MRS) in patients with ABGA as compared to those without ABGA (P = 0.02). The study results did not differ based on age, gender, disease severity and illness duration.

The study demonstrates presence of ABGA in at least a subset of OCD population. The significant correlation between brain Glx levels and presence of ABGA provides a putative neurobiological framework for OCD. The strengths of the study include psychotropic-naive patients, blinded investigators and use of standardized instruments. The limitations include small sample size, use of Glx as proxy measure of glutamate and lack of other disorder controls. Similar studies on a larger sample are warranted for a better understanding.

The authors have not supplied their declaration of competing interest.

The authors have not supplied their declaration of competing interest.

Most individuals diagnosed with schizophrenia must cope with some form of stigmatization. Different types of public stigma, self-stigma and label avoidance, may have negative consequences for these individuals.

The aim of the study was to search the degree of self-stigma in schizophrenia and its association with the clinical and demographic factors.

One hundred and ninety-seven stabilized outpatients diagnosed with schizophrenia spectrum disorders participated in the study. The mean age of the sample was 40 years. All individuals completed the Internalized Stigma of Mental Illness Scale (ISMI) and a demographic questionnaire. The disorder severity was assessed both by a psychiatrist (objCGI-S: the objective version of Clinical Global Impression – Severity scale) and by the patients (subjCGI-S: the subjective version of Clinical Global Impression – Severity scale).

The total score of the ISMI positively correlated with the severity of the disorder measured by the objCGI-S and the subjCGI-S. Additionally, the self-stigma positively correlated with the treatment duration, and the number of hospitalizations. The regression analysis identified these regressors as the most relevant to the self-stigma – the number of hospitalizations, the severity of the disorder rated by a psychiatrist, and the difference between the objective rating and the subjective rating of the severity of the disorder.

Outpatients with psychosis, who have undergone a higher number of hospitalizations, dispose of a higher severity of the disorder and show a bigger discrepancy between their rating of the severity and the psychiatric rating, display a greater degree of self-stigma.

The authors have not supplied their declaration of competing interest.

Alcohol use disorder is a pressing problem in our society. However, only a small percentage of patients with alcohol use disorder are ever treated. Nalmefene acts as an antagonist of mu opioid receptors preventing the pleasurable sensation that often accompanies alcohol consumption, while its modulation of kappa opioid receptors can decrease the dysphoria associated with alcohol withdrawal.

Studying the effect of nalmefene on patients with alcohol use disorder who are trying to reduce their daily alcohol consumption.

This is a descriptive study that pretends to assess the effect of nalmefene 18 mg/day on alcohol intake in a sample of five patients (3 men and 2 women) that came to our psychiatric consultation from March to September 2016. They all had tried in the past to stop or reduce their alcohol consumption but were unable to do so. We initiate follow-up with the patients in psychiatric consultation for the next three months with a monthly frequency.

Out of the 5 patients, 4 reported to have reduced their alcohol consumption over the observation time, going from 32 drinks per week to 18 drinks per week on average. The fifth patient abandoned prematurely the treatment due to the appearance of side effects (nausea). No other relevant side effects were detected.

Nalmefene appears to be effective and safe reducing abusive alcohol intake and avoiding alcohol withdrawal syndrome. Therefore, nalmefene can be considered a good therapeutic option helping reduce alcohol consumption in patients with alcohol use disorder.

The authors have not supplied their declaration of competing interest.

To study the place of electroconvulsive therapy (ECT) in the treatment of major depressive disorder in France and compare it with international recommendations and algorithms.

Multicenter, retrospective study in 12 French university hospitals. Diagnosis, delay between the onset of the episode and the first day of ECT, previous treatments have been identified. Only patients treated for major depressive disorder between 1 January 2009 and 1 January 2014 were included.

A total of 754 patients were included (middle age 61.07 years, sex ratio 0.53). The diagnoses listed were: first major depressive episode (14.95%), bipolar depression (38.85%) and unipolar recurrent depression (46.19%). The delay before ECT, was 11.01 months (13,98), and was significantly longer for first episodes (16.45 months, P < 0.001) and shorter in case of psychotic symptoms (8.76 months, P < 0.03) and catatonic symptoms (6.70, P < 0.01).

The delay before ECT appears on average, four times longer than recommended by treatment algorithms for the management of major depressive disorder. This long delay could be explained by a very heterogeneous access to this treatment in French territory.

The authors have not supplied their declaration of competing interest.

Pisa Syndrome or pleurothotonus is a form of dystonia and often can arise as a side effect of antipsychotic treatment conditioning high morbidity and limiting management options. Despite the fact that the precise mechanism remains unclear, a neurochemical imbalance in dopaminergic and cholinergic transmission but also in serotoninergic and noradrenergic transmission can be a possible pathophysiologic mechanism, which can lead to changes in the axial axis with abnormal posture and marked lateral trunk flexion and abnormal gait.

Regarding a clinical case, the authors intend to review the relevant and current literature on the relationship between psychotropic drugs and Pisa Syndrome.

Description of a clinical case by consulting databases of current and scientifically relevant articles.

The clinical case reports a 48-year-old woman with a history of HIV and Substance Use Disorder, hospitalized for unspecific behavioral changes, characterized by mood changes, self-referential, persecutory and somatic delusional ideas, and delusions of the control of thought. She was medicated with antipsychotics and mood stabilizers, with subsequent development of an acute-onset dystonic condition, characterizing the Pisa Syndrome. In this context, the dose of antipsychotics was lowered and anticholinergics were introduced, with progressive improvement of the clinical picture.

Pisa Syndrome, previously seen as a rare adverse effect, can occur as a dystonic reaction related to the use of psychotropic drugs, so its use should be judicious. Further studies are needed to understand the extent of this association and its pathophysiological mechanisms in order to guide more rigorous therapeutic lines.

No significant relationships.

Gynecomastia refers to the abnormal development of breast tissue in males, often posing a concerning symptom. Often, gynecomastia is associated with multiple factors, including the use of various drugs, notably certain atypical antipsychotics. Gynecomastia is a significant side effect that affects the quality of life of male patients taking antipsychotic medications. Among these, risperidone and paliperidone have been identified as the most prone to causing gynecomastia, although aripiprazole has garnered attention for its superior profile in controlling prolactin and gynecomastia. The relationship between these drugs and the development of gynecomastia lies in their ability to elevate prolactin levels, a hormone that regulates reproductive function and is involved in milk production. Several studies have shown that prolactin levels are more commonly elevated with risperidone and paliperidone prescription, thus triggering gynecomastia.

The study aims to investigate the management of gynecomastia in male patients receiving antipsychotic medications.

This research employs a retrospective analysis of patient records to examine the association between specific antipsychotic drugs, prolactin levels, and the development of gynecomastia, while also evaluating the effectiveness of aripiprazole as an alternative treatment.

We present the case of a 21-year-old male with no prior medical history who initiated treatment with oral paliperidone and later switched to 100 mg of long-acting injectable paliperidone once monthly during his initial admission for psychotic symptoms. After six months, he developed gynecomastia, which was ruled out as breast tissue and was determined to be an increase in adipose tissue. Since his hospital discharge, he has gained 25 kg (30%) in body weight, and his baseline prolactin level has decreased. This weight gain, a common side effect of several antipsychotics, was linked to gynecomastia. However, a promising approach for gynecomastia antipsychotic-associated treatment is aripiprazole, which has a milder impact on prolactin levels. In this case, during the next appointment, a switch to 400 mg of long-acting injectable aripiprazole once-monthly was made, which led to weight loss, a reduction in breast size and blood prolactin levels in the following weeks.

The detection and management of gynecomastia in these patients are crucial to improving their quality of life and treatment adherence. This management encompasses changes in medication, hormonal therapy, or surgery in severe cases. Physicians must be aware of this potential complication when prescribing antipsychotics and closely monitor at-risk patients. In summary, antipsychotic-associated gynecomastia in men represents a medical challenge that requires careful attention and an individualized treatment strategy for each affected patient.

None Declared

Hyperinsulinism is one of the most important causes of hypoglycemia. Rarely, drug toxicity can be a reason. In the context of Munchausen syndrome by proxy (MSBP), toxicity usually occurs in children due to drug administration by a parent or caregiver.

we report a case of a 2-year-old girl with hyperinsulinaemic hypoglycaemia due to insulin injections by her mother.

Mrs. W. is a 28-year-old mother of three children. In her medical history, she was diagnosed with gestational diabetes and treated briefly with insulin. She was hospitalized several times for hypoglycemia and she was diagnosed with factitious disorder. Lately, her youngest daughter aged 2 years old was hospitalized in the pediatric department for repeated unexplained loss of consciousness. The hospitalization lasted 2 months with recurrence of severe hypoglycemia. A full metabolic screen revealed no abnormalities. The mood of the mother appeared quite discordant with the situation. Strict monitoring of maternal behavior showed that the mother gives insulin injections to her daughter. She denied deliberately injecting insulin, and then she accused the health workers. She was referred to our psychiatric department and we diagnosed the MSBP.

MSBP should be considered particularly in patients who have been evaluated by more than one hospital and have discordant test results.

The authors have not supplied their declaration of competing interest.

Suicide is a global issue among the elderly, but few studies have explored the experiences of suicide ideation in older Asian psychiatric outpatients.

The purposes of this study were to explore triggers of suicide ideation among older first onset cases in psychiatric outpatients in Taiwan and their reasons for not executing suicide.

Older psychiatric outpatients (N=24) were recruited by convenience from one medical centre and one regional hospital in northern Taiwan. Data were collected in individual interviews using a semi-structured guide and analysed by content analysis.

Suicide ideation was triggered by illness and physical discomfort, conflicts with family members/friends, illness of family members, death of family members/friends, and loneliness. Participants’ reasons for not executing suicide were family members’ and friends’ support, receiving treatment, finding a way to shift their attention, fear of increasing pressure on one’s children, religious beliefs, and not knowing how to execute suicide.

Understanding these identified triggers of suicide ideation may help psychiatrists open a channel for conversation with their elderly clients and more readily make their diagnosis. Understanding these identified protective factors against executing suicide can help psychiatrists not only treat depression, but also enhance protective factors for their clients.

Hyperprolinemia is defined by high proline levels of blood and its primary type consists on a metabolic disorder that is the result of a number of different genetic defects affecting the degradation of proline. The complex relationship between this disease and different psychiatric phenotypes has been an important subject of study in recent years, suggesting a “common psychiatric phenotype” (Namavar et al. Am J Med Genet B Neuropsychiatr Genet 2021; 186(5), 289-317), though its exact characteristics are yet to be determined. A higher prevalence of psychotic disorders (Guo et al. Metab Brain dis 2018; 33 89-97) explained through altered glutamate metabolism, autism spectrum disorders, developmental delay and intellectual disability has been proposed.

To describe the case of a patient, recently diagnosed of hyperprolinemia type I, presenting a conduct disorder alongside with ADHD, oppositional defiant disorder and an unspecified pervasive developmental disorder.

We present the case of a 15-year-old male that has received follow-up care by our mental health services. The patient was born preterm (35+5 weeks) and required reanimation, oxygen therapy, antiretroviral therapy (biological mother was HIV positive) and pharmacological therapy with phenobarbital (in order to treat methadone withdrawal syndrome). It was adopted nationally when he was 18-month-old and experimented an adequate development during his first years, only highlighting slight psychomotor restlessness and distinctive facial features. During the next years, he receives diagnosis of ADHD (with little to no registered response to amphetamine derivatives), oppositional defiant disorder, social pragmatic communication disorder and fetal alcohol syndrome.

During his first hospital admission, a neuropediatrician was contacted to study the patient and recommended for a metabolic screening to be done, where high blood levels of proline were detected (940.1μmol/L). After this, a procedure of massive exome sequencing of genes that were known to be related to alterations in the metabolism of proline was conducted, finding the mutation c.[1357C>T] in the gen PRODH. This translates to an amino acid replacement in the protein proline dehydrogenase (p.[Arg453Cys]; [Arg453Cys]), which has been studied (Bender et al. Am J Hum Genet 2005; 76 409–420) that it reduced its activity in a 70%, making it a very probable cause of the hyperprolinemia.

There is still scarce evidence of the psychiatric phenotypes presented in patients with hyperprolinemia. Further research is needed in order to accurately define the complex relationship between this metabolic disorder and its effect on the central nervous system.

None Declared