Cannabis use and familial vulnerability to psychosis have been associated with social cognition deficits. This study examined the potential relationship between cannabis use and cognitive biases underlying social cognition and functioning in patients with first episode psychosis (FEP), their siblings, and controls.

We analyzed a sample of 543 participants with FEP, 203 siblings, and 1168 controls from the EU-GEI study using a correlational design. We used logistic regression analyses to examine the influence of clinical group, lifetime cannabis use frequency, and potency of cannabis use on cognitive biases, accounting for demographic and cognitive variables.

FEP patients showed increased odds of facial recognition processing (FRP) deficits (OR = 1.642, CI 1.123–2.402) relative to controls but not of speech illusions (SI) or jumping to conclusions (JTC) bias, with no statistically significant differences relative to siblings. Daily and occasional lifetime cannabis use were associated with decreased odds of SI (OR = 0.605, CI 0.368–0.997 and OR = 0.646, CI 0.457–0.913 respectively) and JTC bias (OR = 0.625, CI 0.422–0.925 and OR = 0.602, CI 0.460–0.787 respectively) compared with lifetime abstinence, but not with FRP deficits, in the whole sample. Within the cannabis user group, low-potency cannabis use was associated with increased odds of SI (OR = 1.829, CI 1.297–2.578, FRP deficits (OR = 1.393, CI 1.031–1.882, and JTC (OR = 1.661, CI 1.271–2.171) relative to high-potency cannabis use, with comparable effects in the three clinical groups.

Our findings suggest increased odds of cognitive biases in FEP patients who have never used cannabis and in low-potency users. Future studies should elucidate this association and its potential implications.

Risky sexual relationships, reckless driving or initiating drug use are examples of health-related risk behaviours that are often related to poor emotional abilities (emotional identification, emotional understanding, facilitating thought and emotional regulation). However, the mechanisms by which this relationship operates have been relatively little studied. It is well known that certain personality traits such as impulsivity and sensitivity to reward are strongly related to risk-taking behaviour.

The aim of this work was to explore the role of these two traits in the relationship between each of the different abilities/ branches of emotional intelligence and health risk behaviour, as well as to identify the emotional ability that best predicts this relationship.

A community sample of 250 participants (Mage = 23.60; 72% women) was used to measure levels of emotional intelligence in each of its branches (through the performance-based ability test MSCEIT), and levels of health risk behaviour, impulsivity and sensitivity to reward.

The results supported the existence of a negative relationship between the four emotional abilities and health risk-taking. Mediation analyses that included all four MSCEIT branches as predictors revealed an indirect effect of the “managing” branch on risk-taking, being the most important branch in predicting health-related risk-taking, due to its effects through impulsivity and sensitivity to reward.

Our results suggest that a strong negative relationship exists between emotional management ability and health risk-taking, highlighting that the emotional components of impulsivity and levels of sensitivity to reward have been shown to be among the mediating factors underlying this relationship. Further experimental research is needed to confirm the role of emotional intelligence, and in particular emotional management, as a protective factor for risk-taking behaviour.

None Declared

Pre-service teachers must confront emotionally demanding situations associated with the profession, and they must be prepared for it. Previous literature has shown that two variables are important for managing mental health in this population: emotional intelligence (EI) and mindset. EI is the ability to perceive, facilitate, understand, and manage emotions, while mindset refers to beliefs about the malleability of various life domains. According to their mindsets, those who believe that attributes are malleable are called incremental theorists, and those who believe attributes are fixed are entity theorists.

This study aimed to explore the influence of intelligence and EI mindset on self-report and ability EI in a sample of 224 female pre-school pre-service teachers (M= 21.27, SD = 4.72).

Participants completed a questionnaire battery, including intelligence mindset, EI mindset, the Mayer–Salovey–Caruso Emotional Intelligence Test, the Trait Meta-Mood scale, and paternal and maternal educational status.

The results showed that incremental EI theories — but not intelligence — were related to higher scores on self-report and ability EI. Specifically, being an incremental theorist of EI predicted 11% and 20% of the variance in global EI and the managing branch of ability EI, respectively

These results suggest that EI mindset training programs could be implemented and evaluated to explore their impact on the EI of female pre-service teachers

None Declared

Tobacco is a highly prevalent substance of abuse in patients with psychosis. Previous studies have reported an association between tobacco use and schizophrenia. The aim of this study was to analyze the relationship between tobacco use and first-episode psychosis (FEP), age at onset of psychosis, and specific diagnosis of psychosis.

The sample consisted of 1105 FEP patients and 1355 controls from the European Network of National Schizophrenia Networks Studying Gene–Environment Interactions (EU-GEI) study. We assessed substance use with the Tobacco and Alcohol Questionnaire and performed a series of regression analyses using case-control status, age of onset of psychosis, and diagnosis as outcomes and tobacco use and frequency of tobacco use as predictors. Analyses were adjusted for sociodemographic characteristics, alcohol, and cannabis use.

After controlling for cannabis use, FEP patients were 2.6 times more likely to use tobacco [p ⩽ 0.001; adjusted odds ratio (AOR) 2.6; 95% confidence interval (CI) [2.1–3.2]] and 1.7 times more likely to smoke 20 or more cigarettes a day (p = 0.003; AOR 1.7; 95% CI [1.2–2.4]) than controls. Tobacco use was associated with an earlier age at psychosis onset (β = −2.3; p ⩽ 0.001; 95% CI [−3.7 to −0.9]) and was 1.3 times more frequent in FEP patients with a diagnosis of schizophrenia than in other diagnoses of psychosis (AOR 1.3; 95% CI [1.0–1.8]); however, these results were no longer significant after controlling for cannabis use.

Tobacco and heavy-tobacco use are associated with increased odds of FEP. These findings further support the relevance of tobacco prevention in young populations.

Attention-deficit/hyperactivity disorder (ADHD) is a psychiatric condition in which children suffer from inattentiveness, hyperactivity, and or impulsivity. ADHD patients frequently present comorbid psychiatric disorders: in adults, the most common are depression, substance-related disorders, anxiety, and eating disorders. Children and adolescents present conduct disorders, learning disorders, anxiety and depression. Since ADHD and its psychiatric comorbidities share similarities, a partial overlap of their pathophysiological mechanisms has been suggested. ADHD, can be treated with lisdexamfetamine (LDX), a prodrug indicated by the FDA as treatment for binge eating disorder (BED) and ADHD.

To evaluate, through a systems biology-based in silico method, the efficacy of LDX as first-line ADHD treatment to improve ADHD psychiatric comorbidities. Furthermore, we explored the molecular mechanisms behind LDX’s action.

We used the systems biology- and artificial intelligence-based Therapeutic Performance Mapping System (TPMS) technology to characterise and model ADHD comorbidities. Artificial neural networks (ANNs) algorithms were used to identify specific relationships between protein sets. Finally, we modelled the mechanisms of LDX for the most relevant comorbidities by using sampling methods and comorbidity-specific virtual patients in each case.

This study predicts a strong relationship between LDX’s targets and proteins involved in BED and depression (Fig 1). Our results could be explained not only by LDX role in neurotransmitter regulation, but also by modulation of neuroplasticity (BDNF/NTRK2, GSK3), neuroinflammation (interleukins, inflammasome), oxidative stress (NOS2, SOD), and the hypothalamic-pituitary-adrenal (HPA) axis (CRH, CRHR1).

These findings could be used in pre-clinical and clinical future investigations to assess optimal treatment for ADHD patients with psychiatric comorbidities.

JRGC: speaker for Takeda and Shire, research funding from Shire and Lumbeck, collaborations with Laboratoires Servier JQ: speaker or scientific advisor for Takeda, Janssen, Rubio. Investigation funding: Instituto de Salud Carlos III. PR, CM, TPR: full-ti

Health services research (HSR) is affected by a widespread problem related to service terminology including non-commensurability (using different units of analysis for comparisons) and terminological unclarity due to ambiguity and vagueness of terms. The aim of this study was to identify the magnitude of the terminological bias in health and social services research and health economics by applying an international classification system.

This study, that was part of the PECUNIA project, followed an ontoterminology approach (disambiguation of technical and scientific terms using a taxonomy and a glossary of terms). A listing of 56 types of health and social services relevant for mental health was compiled from a systematic review of the literature and feedback provided by 29 experts in six European countries. The disambiguation of terms was performed using an ontology-based classification of services (Description and Evaluation of Services and DirectoriEs – DESDE), and its glossary of terms. The analysis focused on the commensurability and the clarity of definitions according to the reference classification system. Interrater reliability was analysed using κ.

The disambiguation revealed that only 13 terms (23%) of the 56 services selected were accurate. Six terms (11%) were confusing as they did not correspond to services as defined in the reference classification system (non-commensurability bias), 27 (48%) did not include a clear definition of the target population for which the service was intended, and the definition of types of services was unclear in 59% of the terms: 15 were ambiguous and 11 vague. The κ analyses were significant for agreements in unit of analysis and assignment of DESDE codes and very high in definition of target population.

Service terminology is a source of systematic bias in health service research, and certainly in mental healthcare. The magnitude of the problem is substantial. This finding has major implications for the international comparability of resource use in health economics, quality and equality research. The approach presented in this paper contributes to minimise differentiation between services by taking into account key features such as target population, care setting, main activities and type and number of professionals among others. This approach also contributes to support financial incentives for effective health promotion and disease prevention. A detailed analysis of services in terms of cost measurement for economic evaluations reveals the necessity and usefulness of defining services using a coding system and taxonomical criteria rather than by ‘text-based descriptions’.

This study investigates associations of several dimensions of childhood adversities (CAs) with lifetime mental disorders, 12-month disorder persistence, and impairment among incoming college students.

Data come from the World Mental Health International College Student Initiative (WMH-ICS). Web-based surveys conducted in nine countries (n = 20 427) assessed lifetime and 12-month mental disorders, 12-month role impairment, and seven types of CAs occurring before the age of 18: parental psychopathology, emotional, physical, and sexual abuse, neglect, bullying victimization, and dating violence. Poisson regressions estimated associations using three dimensions of CA exposure: type, number, and frequency.

Overall, 75.8% of students reported exposure to at least one CA. In multivariate regression models, lifetime onset and 12-month mood, anxiety, and substance use disorders were all associated with either the type, number, or frequency of CAs. In contrast, none of these associations was significant when predicting disorder persistence. Of the three CA dimensions examined, only frequency was associated with severe role impairment among students with 12-month disorders. Population-attributable risk simulations suggest that 18.7–57.5% of 12-month disorders and 16.3% of severe role impairment among those with disorders were associated with these CAs.

CAs are associated with an elevated risk of onset and impairment among 12-month cases of diverse mental disorders but are not involved in disorder persistence. Future research on the associations of CAs with psychopathology should include fine-grained assessments of CA exposure and attempt to trace out modifiable intervention targets linked to mechanisms of associations with lifetime psychopathology and burden of 12-month mental disorders.

Course and outcome in schizophrenia are heterogeneous. Numerous studies have shown an association between the presence of negative symptoms and psychosocial and occupational functioning of patients.

To analyse the prevalence of negative symptoms in the course of illness in first episode psychosis and chronic schizophrenia and to establish its relation with the functional outcome.

43 patients with a first-episode psychosis (FEP) from our area were compared with 43 chronic schizophrenic patients and 43 normal controls from a parallel area. They were matched one on one for age, gender and years of education. All subjects were compared regarding psychopathology and functional outcome terms. Patients were examined with Positive and Negative Syndrome Scale (PANSS) for clinical symptom. Longitudinal functionality was prospectively assessed with the Clinical Global Impression (CGI) and Global Assessment of Functioning (GAF) rating scales.

We found significant differences between FEP and chronic patients in negative symptom severity (t = -4.97, p< 0.001) and global assessment of functioning (t = 7.58, p< 0.001). There was no statistically significant difference between the two groups in PANSS positive and general components or Clinical Global Impression. Negative symptom severity was associated with poorer GAF ratings in first episode psychosis and chronic schizophrenia.

Negative symptoms appear to be persistent. In our study negative symptom severity was associated with social and functional impairment, defined as Global Assessment of Functioning Scale score of less than or equal to 60.

We aimed to identify best predictors of cognitive and functional disability in chronic schizophrenia over time.

We examined 95 hospitalised patients with schizophrenia (DSM-IV criteria) in a long stage unit and 53 healthy controls (matched for age, gender, and years of education). Neuropsychological assessment included tests for Verbal Memory, Working Memory, Executive Functioning and Processing Speed. Functional Disability was assessed with the Disability Assessment Schedule (DAS-WHO) both at baseline and 6 months after.

As expected, patients" performance was significantly lower than healthy comparison subjects on all neurocognitive variables at baseline. Most, but not all, neurocognitive measures were positively correlated with the Functional Disability domains at follow up, including Self Care Management, Vocational Outcome, Family Contact and Social Competence. Results of mediation analyses suggest that all significant relationships identified between cognitive measures and functional outcome were significantly mediated by the Index Processing Speed (PS) with various effects ((between p < 0.05 for PS (z = -2.06) and p < 0.01 for PS (z = -3.01)).

Our data show that Processing Speed plays a determinant role in the relationship among neurocognitive symptoms and Self Care, Vocational Outcome and Social Competence. the model emphasizes the role of PS as the best longitudinal predictor of the level of autonomy in chronic patients with schizophrenia. PS acts as a pathway through which VM, EF and WM predict the course of patients’ functional ability over time.

Although it is well know that the substance use during pregnancy has a negative impact on mother and child health, there are few data on pregnancy - related substance use as a risk factor for postpartum depression and child outcomes.

Aims: To determine maternal and child outcomes at 8 and 32 weeks postpartum of women who reported substance use during pregnancy.

This is a cohort study of 1804 Caucasian women in postpartum. Exclusion criteria: psychiatric disorders during pregnancy. Women were evaluated at 2-3 days, 8 and 32 weeks postpartum. Socio-demographic, obstetric, personal and family psychiatric history and substance use during pregnancy; the Edimburgh Postpartum Depression Scale (EPDS) were assessed. All women with EPDS>9 at 8 and 32 weeks were evaluated by a structured interview (DIGS) for DSM-III major depression.

The mean (SD) age was 31.7 (4.6). Forty-six percent of them were primiparous. Thirty-one percent has a family and 16% a psychiatry history. Fifty percent of women reported substance use during pregnancy: 42% caffeine, 21.6% nicotine, 8% alcohol and 0.6% cannabis. Incidence of major postpartum depression was: 12.7%. Incidence of: Apgar scores < 7 at 5 min after birth:0.4%, gestational age at delivery < 37 weeks:7.3%, birth weigt < 2.5 Kg:7.3%, and congenital malformations:1.4%.

In the presentation, the maternal and child perinatal outcomes of women exposed to licit and ilicit drugs will be summarize and will include a discussion of the future clinical and research implications. This work has been done in part with Grants: GO3/184;FIS:PI04178;PI041635,PI041783,PI041779,PI041758,PI041761,PI041791,PI041766,PI041782,RD06/0001/1009; CIBER-SAM.

To examine the relative contributions of psychiatric symptoms, functional disability, neuropsychological functioning and sociodemographic variables to quality of life (QOL) in patients with chronic schizophrenia.

We examined 165 hospitalised patients with long term schizophrenia (DSM-IV). Measures of psychiatric symptoms included depression (Calgary depression Scale), insight (David Insight Scale), symptom severity (BPRS) and PANSS (Positive and Negative Symptom Scale). Neuropsychological battery included tests for verbal memory, executive functioning, verbal fluency, working memory, motor speed and processing speed. Functional disability was assessed with the Disability Assessment Schedule (DAS-WHO) and Quality of life was assessed with the Quality of Life Scale.

Age, years of evolution, negative symptoms, insight and neuropsychological variables (except motor speed) all were significantly related to level of quality of life. in a multiple regression analysis, entering the neuropsychological functioning, functional disability and negative symptoms generated a model which accounted for a 74.9% of the variance in QOL. Functional disability, as expected, accounted for 56% of the variance, whereas Processing Speed explained an additional 6.2%. Symptom Severity and Verbal Fluency predicted 3.7% and 3.5% of the variance, respectively. Negative symptoms, Verbal Memory and Vocabulary, were also significant predictors in the model, but had less predictive value. However, Positive Symptoms and Sociodemographic Variables did not significantly contribute to predict quality of life.

Our findings support the predictive value of neuropsychological functioning, functional disability and severity of negative symptoms in long term quality of life in schizophrenia.

Chronic hepatitis C infection (CHC) represents a public health problem that affects around 3% of population worldwide. Pegylated Interferon-alpha (PegIFN-α) and Ribavirin (RBV) is the recommended treatment reaching about 40–80% of sustained virological response. However, a common treatment side-effect is induced-depression that impairs patient's quality of life and treatment adherence (1,2). This paper showed polymorphisms in HTR1A, NCR1, TPH2 genes as predictive variables of IFN-induced depression.

396 consecutive, euthymic, CHC outpatients treated with PegIFN-α/RBV were included. Patients were assessed at baseline, 4, 12, 24 and 48 weeks of treatment using PHQ and MINI-DSM-IV-R interview to diagnose depression. Survival analysis was performed. in the univariated analysis functions were compared using logrank test. Significative variables (0.1 level) were extracted for the multivariated model, using a Weibull regression model.

The incidence of induced-depression along the treatment was 39.4%. Polimorphisms on HTR1A (P = 0.0104), TPH2 (P = 0.0231) and NRC1 (P = 0.0702) genes predicted IFN-induced depression.

Genes related with serotonine and inflamation system may play an important role in the pathogenesis of IFN-induced depression. Knowledge of predictive variables for IFN-induced depression may help to better manage patients at risk.

The death rate due to suicide in elderly people is particularly high. As part of suicide selective prevention measures for at-risk populations, the WHO recommends training “gatekeepers”.

In order to assess the impact of gatekeeper training for members of staff, we carried out a controlled quasi-experimental study over the course of one year, comparing 12 nursing homes where at least 30% of the staff had undergone gatekeeper training with 12 nursing homes without trained staff. We collected data about the residents considered to be suicidal, their management further to being identified, as well as measures taken at nursing home level to prevent suicide.

The two nursing home groups did not present significantly different characteristics. In the nursing homes with trained staff, the staff were deemed to be better prepared to approach suicidal individuals. The detection of suicidal residents relied more on the whole staff and less on the psychologist alone when compared to nursing homes without trained staff. A significantly larger number of measures were taken to manage suicidal residents in the trained nursing homes. Suicidal residents were more frequently referred to the psychologist. Trained nursing homes put in place significantly more suicide prevention measures at an institutional level.

Having trained gatekeepers has an impact not only for the trained individuals but also for the whole institution where they work, both in terms of managing suicidal residents and routine suicide prevention measures.

Neuroleptic malignant syndrome (NMS) is an uncommon but potentially fatal adverse effect of neuroleptic, both classic and atypical drugs.

To review the incidence, clinical characteristics, diagnosis and treatment of NMS.

We have described the case of a man of 32 years of age diagnosed with bipolar disorder treated with lithium. He precised high-dose corticosteroids after having tonsillitis. Then, he presented manic decompensation requiring neuroleptic treatment (oral risperidone). After 72 hours, he presented an episode characterized by muscular rigidity, fever, altered mental status and autonomic dysfunction. Life support measures and suspension of neuroleptic treatment were required.

A literature review of the NMS was performed using the PubMed database.

The frequency of NMS ranges from 0.02 to 2.4%. The pathophysiology is not clearly understood but the blockade of dopamine receptors seems to be the central mechanism. Some of the main risk factors described are: being a young adult, the concomitant use of lithium and metabolic causes, among others. NMS occurs most often during the first week of treatment or after increasing the dosage of the neuroleptic medication. Some issues of NMS are those related with diagnosis, treatment and reintroduction of antipsychotic treatment or not.

NMS can be difficult to diagnose due to the variability in the clinical symptoms and presentation. Because of it diagnosis is of exclusion, clinicians should always take it into consideration when a patient is treating with neuroleptic, especially when the dosage has been recently increased. NMS is a clinical emergency.

The authors have not supplied their declaration of competing interest.

Glucocorticoids are widely prescribed for a variety of diseases and are known to cause neuropsychiatric as well as somatic side effects.

To review the incidence, clinical characteristics, course and treatment of neuropsychiatric effects of glucocorticoids.

We have described the case of a 86-year-old woman. She had no personal and no psychiatric medical history in her family. She presented wrist arthritis requiring high doses of an oral corticoid treatment (prednisona 20 mg/d). After a week, she started with symptoms characterised by persecutory and surveillance delusions. Organicity was ruled out. The patient got a progressive recovery after starting anti-psychotic medication and progressive reduction of the steroid drugs.

We have performed a literature review of the neuropsychiatric complications of glucocorticoids using the PubMed database.

Neuropsychiatric effects of glucocorticoids involve affective, behavioural, and cognitive manifestations. The incidence is variable, between 2 and 60% of patients who receive steroids. Although the effects of glucocorticoids are unpredictable, the administered dose is the most significant risk factor for the development of neuropsychiatric symptoms. Dosage reduction typically results in clinical recovery. Although the limited data on this subject, it is a problem that clinicians face on their regular basis. The administration of anti-psychotics or mood stabilizers may be beneficial in the prevention and treatment of this syndrome.

The neuropsychiatric effects of glucocorticoids are unpredictable and non-specific. More controlled trials are needed in order to perform evidence-based clinical guidelines for the treatment with glucocorticoids and for the prevention of neuropsychiatric manifestations.

The authors have not supplied their declaration of competing interest.

Intensive treatment in partial hospitalization unit may represent an efficient alternative to traditional inward hospitalization. However, there is evidence suggesting that this clinical resource may not be equally effective for every psychiatric disorder.

We aimed to study possible differences in the effectiveness of treatment in a partial hospitalization regime for different psychiatric disorders.

Three hundred and thirty-one patients were admitted to the Valdecilla acute psychiatric day hospital between January 2013 and January 2015. Clinical severity was assessed using BPRS-E and HoNOS scales at admission and discharge. Other relevant clinical and socio-demographic variables were recorded. For statistical comparisons, patients were clustered into 4 wide diagnostic groups (non-affective psychosis; bipolar disorder; depressive disorder; personality disorder).

We observed a significant difference in the status of discharge (χ2 = 12.227; P = 0.007). Thus, depressive patients were more frequently discharged because of clinical improvement, while patients with a main diagnose of personality disorder abandoned the treatment more frequently (23% vs. 4,0%)

When analysing the clinical outcome at discharge, we found that patients with a diagnosis of bipolar disorder showed greater improvement in BPRS (F = 5.305; P = 0.001) than those diagnosed of psychosis or depressive disorder. Interestingly, we found no significant differences between diagnoses in hospital re-admission in the following 6 months after being discharged.

Our results suggest that acute treatment in partial hospitalization regime may be more effective for bipolar and depressive disorder, and particularly less effective for those patients with a personality disorder.

The authors have not supplied their declaration of competing interest.

There is substantial evidence suggesting that individual variability in antipsychotic treatment response could be genetically determined. Disrupted-in-Schizophrenia 1 (DISC1) gene has been previously associated to the illness and to treatment response in a sample of patients suffering from psychosis. However, there is a lack of studies on the effect of DISC1 on treatment response in samples of first episode psychosis.

The aim of this study was to explore the relation between variations in DISC1 gene and treatment response to antipsychotics in a sample of drug-naïve patients with a first episode of psychosis.

Two hundred and twenty Caucasian drug-naive patients experiencing a first episode of non-affective psychosis were genotyped for rs821616 (Ser704Cys), rs6675281 (Leu607Phe) and rs1000731. Early (6 weeks) response to antipsychotic treatment was assessed with the Brief Psychiatric Rating Scale, the Scale for the Assessment of Positive Symptoms, and the Scale for the Assessment of Negative Symptoms. Other clinical and socio-demographic variables were recorded to eliminate potential confounding effects.

We found a significant association between rs1000731 and treatment response. Thus, those patients homozygous for the G allele of rs1000731 were more frequently non-responders, measured with SANS, after 6 weeks of treatment, than those carrying the A allele (X2 = 4.019; P = 0.032). Moreover, when analysing the clinical improvement longitudinally, we observed that those patients carrying the A allele for the rs1000731 presented a greater improvement in positive symptoms dimension (F = 8.905; P = 0.003).

Our results suggest a minor contribution to antipsychotic drug response of genetic alterations in the DISC1 gene.

The authors have not supplied their declaration of competing interest.

Tuberous sclerosis complex is a rare genetic disorder leading to the growth of hamartomas in multiple organs, including cardiac rhabdomyomas. Children with symptomatic cardiac rhabdomyoma require frequent admissions to intensive care units, have major complications, namely, arrhythmias, cardiac outflow tract obstruction and heart failure, affecting the quality of life and taking on high healthcare cost. Currently, there is no standard pharmacological treatment for this condition, and the management includes a conservative approach and supportive care. Everolimus has shown positive effects on subependymal giant cell astrocytomas, renal angiomyolipoma and refractory seizures associated with tuberous sclerosis complex. However, evidence supporting efficacy in symptomatic cardiac rhabdomyoma is limited to case reports. The ORACLE trial is the first randomised clinical trial assessing the efficacy of everolimus as a specific therapy for symptomatic cardiac rhabdomyoma.

ORACLE is a phase II, prospective, randomised, placebo-controlled, double-blind, multicentre protocol trial. A total of 40 children with symptomatic cardiac rhabdomyoma secondary to tuberous sclerosis complex will be randomised to receive oral everolimus or placebo for 3 months. The primary outcome is 50% or more reduction in the tumour size related to baseline. As secondary outcomes we include the presence of arrhythmias, pericardial effusion, intracardiac obstruction, adverse events, progression of tumour reduction and effect on heart failure.

ORACLE protocol addresses a relevant unmet need in children with tuberous sclerosis complex and cardiac rhabdomyoma. The results of the trial will potentially support the first evidence-based therapy for this condition.