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Trial protocols and manuals are critical documents outlining core elements of a clinical trial, such as theoretical background, recruitment strategies, intervention structure and components, and control comparators. Availability of these documents is essential as it prevents trial duplication, helps detect or avoid research misconduct, and facilitates tracking of trial results. Moreover, a detailed description of intervention components is crucial for the methodological rigor of advanced meta-research approaches, such as component network meta-analysis (cNMA). However, clinical trials often fail to make these documents publicly accessible, either before or after the trial ends, for instance as supplementary materials to publications. Attempts to obtain these documents by contacting researchers directly are frequently unsuccessful. Therefore, alternative avenues for retrieving these materials must be explored.
Objectives
This study aims to assess the feasibility of retrieving trial protocols and manuals through alternative sources, such as ethics committees/IRBs, funding bodies, and sponsors.
Methods
In the context of a cNMA on psychotherapeutic interventions for eating disorders, we identified 34 published studies (12 on anorexia nervosa and 22 on bulimia nervosa); for each, we reviewed the full-text publications to identify potential sources to retrieve trial protocols and manuals. To this end, we adopted a systematic, stepped approach, investigating: 1) explicit mentions of published trial protocols; 2) trial registration details, including ethics committees/IRBs; 3) institutions or clinics whose ethics committees approved the protocol; 4) specific trial sites or study sponsors/funders; 5) first author’s affiliation.
Results
Of the 34 publications analyzed: 1) 2 studies had published trial protocols; 2) 11 studies were registered in trial databases and reported ethics committee or IRB details; 3)16 studies identified the ethics committee or IRB that approved the protocol; 4) 26 studies reported one or more specific trial sites or funding bodies/sponsors; 5) 31 studies provided the first author’s institutional affiliation.
Overall, 26 studies had at least one contact associated with organizations that would have reviewed the trial documents, and 31 studies had at least one institutional contact potentially connected to the trial’s documentation. For 3 studies no information on ethics committees, trial site, or author affiliation was available.
Conclusions
Despite the recognized importance of making trial protocols publicly available, spontaneous dissemination remains rare in clinical trials on psychotherapeutic interventions. In the absence of published protocols or trial registration details, our feasibility study highlights that full-text publications of trial results can offer multiple potential points of contact that may provide access to such documentation.
ESCAPE-LTE was a phase 4, long-term, open-label extension (OLE) study for patients (pts) with treatment resistant depression (TRD) who were continuing esketamine nasal spray (ESK-NS) treatment following ESCAPE-TRD. ESCAPE-TRD was a randomised, phase IIIb trial comparing the efficacy and safety of ESK-NS versus quetiapine extended release (Q-XR), when both were flexibly dosed alongside an ongoing selective serotonin/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI), in pts with TRD. The study demonstrated that ESK‑NS significantly increased the probability of achieving remission at Week 8, and of being relapse‑free through Week 32 after remission at Week 8, versus Q-XR (Reif et al. NEJM 2023; 389 1298–309).
Objectives
To assess the long-term safety, tolerability and efficacy of ESK-NS alongside an SSRI/SNRI in pts with TRD. Here, the study design of ESCAPE-LTE is described; top-line results will be reported in the poster.
Methods
ESCAPE-LTE was a single-arm, 2-year OLE to ESCAPE-TRD in 14 countries. Pts eligible for ESCAPE-LTE were those who completed ESK-NS treatment in combination with an SSRI/SNRI in ESCAPE-TRD through to the end of the study (Week 32), continued to benefit from the ESK-NS treatment regimen and for whom commercial ESK-NS was not accessible in their country. The starting dose of ESK-NS was based on the pts’ dose (28 mg [≥65 years and adults of Japanese ancestry], 56 mg or 84 mg) and frequency (weekly or biweekly) at completion of the maintenance phase (Week 32) of ESCAPE-TRD. Investigators were able to change the dose and frequency within label recommendations during the OLE based on clinical judgment.
The primary objective was to assess the long-term safety and tolerability of ESK-NS. The secondary objective was to assess the long-term efficacy of ESK-NS based on the proportion of pts being relapse-free at Week 104 (or end-of-study).
The primary endpoints were the number of pts who developed treatment-emergent adverse events, and suicidal ideation and behaviour, assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS). Safety assessments also included body weight and vital sign measurements and clinical laboratory tests. The secondary endpoint was no relapse until the end of the prospective observation at Week 104 (or end-of-study); relapse was defined as a worsening of depressive symptoms as indicated by a total Montgomery-Åsberg Depression Rating Scale (MADRS) score of ≥22 at two consecutive assessments; hospitalisation for worsening depression, suicide prevention or attempt; or any other event assessed by the investigator to be indicative of relapse.
Results
183 pts were enrolled in the ESCAPE-LTE. Top-line study results will be reported in the poster.
Conclusions
Results from the ESCAPE-LTE will provide evidence for the long-term safety, tolerability and efficacy of ESK-NS as a treatment for pts with TRD.
Breast cancer is the leading cancer among women, and its early diagnosis is vital for improving survival rates. However, many women delay seeking medical attention after noticing symptoms. Factors such as lack of awareness, fear of diagnosis, financial constraints, and family responsibilities often contribute to these delays. In addition to the physical burden of cancer, psychological distress is a common but often overlooked aspect of the patient experience.
Objectives
To identify the prevalence and causes of delayed consultation as well as the different types of psychological distress (practical, familial, emotional, spiritual, and physical) among patients with breast cancer.
Methods
We conducted a descriptive and analytical study over a one-year period (June 2021 - May 2022) in the oncology department of the Maternity and Neonatology Center of Monastir. Data were collected using information sheets, interviews, and medical records. Psychological impact was assessed using the Distress Thermometer (DT), a visual scale from 0 to 10, accompanied by a questionnaire on practical, familial, emotional, spiritual, and physical issues. The median consultation delay and reasons for the delay were also examined.
Results
Among the 150 patients diagnosed with breast cancer who received treatment and follow-up at the Maternity and Neonatology Center of Monastir, the median consultation delay was 28 days, with delays ranging from 1 to 912 days. Thirty-five patients (23.3%) experienced late consultations, defined as a delay of more than 90 days. The main reasons for the delay included 62.2% of patients not suspecting cancer after the first functional signs, 11.1% fearing the diagnosis, and 8.9% facing financial issues or family and professional responsibilities. Among the 104 patients who completed the Distress Thermometer questionnaire, 31.7% had a distress level below 4, while 68.3% had a distress level of 4 or above. The most frequently reported practical problems were child care (26.92%) and meal preparation (18.26%). Familial problems mainly concerned relationships with children (26.92%). Emotional issues included fear (50%), nervousness (50.96%), and sadness (50%). Regarding spiritual concerns, 32.6% of patients had spiritual or religious concerns, and 67 patients reported physical problems.
Conclusions
The results show that the majority of patients experience high psychological distress, particularly in emotional and practical domains. The median consultation delay is 28 days, with a significant delay in 23.3% of patients. It is therefore crucial to improve awareness and psychological support to reduce consultation delays and optimize breast cancer management and patient well-being.
Eating disorders (EDs) are an important and highly prevalent class of disorders worldwide, with the global lifetime prevalence reaching more than 8% in females and 2% in males. Also, EDs associate high rates of mortality, comorbidity, organic and psychiatric complications, and years lived with disability (YLD), low quality of life and increased healthcare costs. Yet, the pharmacological armamentarium available to treat EDs is quite reduced, a phenomenon that creates difficult challenges for the case management of these patients.
Objectives
To review the existing literature in order to find new targets explored for the treatment of EDs.
Methods
A literature review was conducted in four electronic databases (PubMed, EMBASE, Cochrane, and Clarivate/Web of Science) and the US National Library of Medicine database for clinical trials (www.clinicaltrials.gov) to find clinical studies published between January 2000 and September 2024. The keywords used were “eating disorders”, “feeding disorders”, “anorexia nervosa”, “bulimia nervosa”, “binge eating disorder”, “drugs in pipeline”, and “pharmacological treatment”. Only adult participants were included, and only sources published in English were selected.
Results
The following data are based on 33 sources found during the literature search. Lisdexampheatmine and vortioxetine are explored for in BED, with the first agent receiving FDA approval for moderate and severe binge eating disorder (BED) in adults. Olanzapine is explored in patients with anorexia nervosa (AN), chromium picolinate for BED, methylphenidate + CBT also for BED, and antibiotics for bulimia nervosa (BN). Psychedelics, e.g., psilocybin and MDMA, are explored for AN and BED, but there is a limited number of trials dedicated to these agents that reach only phase 2a. Therapeutic guidelines dedicated to EDs have very few level A recommendations, i.e., fluoxetine and topiramate for BED, lisdexamphetamine for BED, and olanzapine for AN, with several cautionary notes regarding adverse events and restricted availability for some of these drugs.
Conclusions
There is a dearth of good-quality data regarding the efficacy and tolerability of newer pharmacological agents for treating EDs. Therapeutic guidelines dedicated to this type of disorders have only scarce recommendations regarding pharmacotherapy, and there is an urgent need to find more agents that could improve the prognosis of patients with ED.
Antipsychotic medications, particularly atypical antipsychotics, are commonly associated with metabolic side effects such as weight gain, dyslipidemia, and insulin resistance. These disturbances significantly increase the risk of cardiovascular disease and mortality, especially in patients treated with clozapine and olanzapine. It is not always feasible to discontinue these treatments, as the decision largely depends on the clinical context. Therefore, addressing these metabolic side effects requires specific pharmacological interventions to mitigate their impact.
Objectives
This non-systematic review aims to assess the evidence supporting pharmacological interventions in managing antipsychotic-induced metabolic disturbances.
Methods
Relevant and recent studies or reviews were selected from the PubMed electronic database using search terms related to antipsychotic-induced metabolic disturbances and pharmacological interventions to manage them.
Results
Current evidence suggests the need for early and aggressive pharmacological intervention in patients experiencing antipsychotic-induced weight gain. Non-pharmacological interventions, such as physical activity and dietary changes, are often insufficient to mitigate these iatrogenic effects. Pharmacological interventions to reduce metabolic risk in individuals with severe mental illness may include the introduction of an antipsychotic with a more favourable metabolic profile, modification of antipsychotic therapy (dose adjustment, augmentation with another antipsychotic with a lower metabolic risk or switching to another antipsychotic with a lower metabolic risk) and treatment of medical conditions (through the use of drugs such as metformin, statins, among others). Based on updated scientific evidence, the most effective pharmacological treatments for reducing weight gain associated with second-generation antipsychotics are metformin, GLP-1 receptor agonists, topiramate, zonisamide, and nizatidine. The adjunctive use of aripiprazole also reduces lipid levels and weight and attenuates negative symptoms in patients with schizophrenia and metabolic syndrome. Metformin is considered the best-tolerated intervention, while topiramate is the least tolerated.
Conclusions
Pharmacological interventions, particularly the use of metformin and GLP-1 analogues, offer promising results in managing antipsychotic-induced metabolic disturbances. These interventions improve weight management, glucose levels, and lipid profiles. More large-scale randomized trials are needed to further validate these interventions and assess long-term safety and efficacy.
The U.S. National Institute of Mental Health (NIMH) Research Domain Criteria (RDoC) offers a framework to facilitate clinical research for psychopathology. Unique features include an emphasis on transdiagnostic dimensions spanning normal and abnormal ranges of function, novel independent variables (mechanisms, not diagnoses), and the integration of different kinds of observations (neural, psychological, self-report). In this talk, principles and pragmatics of RDoC approach are illustrated with examples from RDoC-framed clinical research, and the clinical significance is discussed.
Bipolar disorder is a complex psychiatric condition marked by severe mood swings, including prolonged depressive episodes that constitute approximately 50% of the illness duration. While there is substantial evidence supporting interventions for manic and hypomanic episodes, therapeutic options for bipolar depression remain insufficient and often ineffective. Accelerated repetitive transcranial magnetic stimulation (arTMS) has emerged as a promising treatment modality with the potential to address these gaps. arTMS offers rapid antidepressant effects comparable to traditional repetitive transcranial magnetic stimulation (rTMS) protocols while maintaining a favorable safety and tolerability profile.
Objectives
This prospective, open-label, multicenter study investigates the efficacy and safety of arTMS in treating bipolar II disorder during depressive phases.
Methods
The study enrolled 20 patients who underwent a five-day, four-times-daily arTMS protocol targeting the left dorsolateral prefrontal cortex (DLPFC). The primary outcome measure was the Montgomery–Åsberg Depression Rating Scale (MADRS), assessed at baseline, immediately post-treatment, and at one- and three-month follow-ups. Secondary outcomes included safety and tolerability, with a focus on the risk of manic or hypomanic switches as measured by the Young Mania Rating Scale (YMRS).
Results
Results indicated a significant reduction in MADRS scores from baseline to immediately post-treatment, with a mean difference of -9.80 (Cohen’s d=1.065, p<0.001). Continued improvements were observed at one month (-15.60, d=1.695, p<0.001) and three months (-19.70, d=2.140, p<0.001), with response rates increasing from 15% immediately after treatment to 60% at three months, and remission rates rising from 5% to 55% over the same period. Importantly, arTMS did not result in any significant increase in YMRS scores, indicating no emergence of manic symptoms, and no hypomanic switches were reported.
Conclusions
The findings underscore the rapid onset and sustained effectiveness of arTMS for bipolar depression, with improvements observed immediately after treatment and continuing over the subsequent months. The progressive rise in response and remission rates suggests that therapeutic benefits may become more pronounced over time, highlighting the importance of considering delayed treatment responses. Moreover, the lack of adverse effects on mood polarity supports arTMS as a safer alternative compared to traditional pharmacological treatments, which are often associated with a risk of manic episodes. Future research should include larger, randomized, sham-controlled trials to validate these findings and further explore the neurobiological mechanisms underlying arTMS’s rapid antidepressant effects.
Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infection (PANDAS) is an autoimmune disease caused by Group A Streptococcus bacteria. It usually affects children 3 to 12 years of age, however, have also been reported among adolescents. PANDAS presents with neuropsychiatric symptoms which can overlap or coincide with existing psychiatric disorders that often emerge further as children get older. Identifying the causation of events may be challenging making such cases difficult to manage.
Objectives
To understand the presentation of PANDAS with concurrent mood disorder and its management.
Methods
Clinical case report
Results
A 16-year-old female was initially admitted due to blank stares, disorganized behavior, paranoia, aggression, and depressive symptoms. Her EEG and MRI were normal. She did not tolerate Fluoxetine but improved with Olanzapine (12.5mg). At 17 years old, she had throat discomfort, colds, and headache with supportive management done. She felt depressed and suicidal due to school stress prompting her second admission. She was started on Escitalopram and Olanzapine was shifted to Quetiapine. Subsequently, she developed manic symptoms with hallucinations and worsened paranoia. Escitalopram was discontinued and Quetiapine was increased (300mg). Bipolar I Disorder with Psychotic Features was considered. Shortly after, she developed explosive motor and vocal tics, involuntary screeching with head gagging and jerking and urges to choke herself or hit her head on the wall. Quetiapine was discontinued and was placed on Clonazepam (0.25mg/8h). Work ups revealed normal EEG, positive ASO and ESR, and findings of Mild Rheumatic Heart Disease on 2D Echo, hence, the assessment of PANDAS. Treatment is multidisciplinary involving antimicrobial, immunomodulatory, and psychotherapeutic interventions. Medications were then adjusted to: Co-amoxiclav (625mg/10days) followed by Penicillin V (250mg/12h), Aripiprazole (15mg), and Divalproex Sodium (1000mg). Intravenous immunoglobulin was suggested due to her moderate to severe presentation. Henceforth, improvement of symptoms were noted and she was reintegrated back home.
Conclusions
Diagnosing PANDAS can be complex among adolescent due to concurrent issues with similar symptom presentation. PANDAS is episodic in nature but may also have sawtooth-like presentation which may indicate first admission as an episode and the second, a flare up. The case could have also been a combination of PANDAS and Bipolar Disorder thus the severity. Regardless, the interplay of biological and psychological facets have evidently magnified her predispositions leading to an intense manifestation of symptoms.
According to the American Academy of Child and Adolescent Psychiatry (AACAP), 50% of all lifetime cases of mental illness begin by age 14, and 75% by age 24 (1). Development is a life-long process, but adult development is generally more gradual and less critical than that of children and adolescents. That is why the role of development in child psychiatry is particularly important, contrary to the adult psychiatry, more focused on the categorical definition of the observed clinical situation.
Autism Spectrum Disorders (ASD) in particular, characterized by heterogeneity, may evolve to adulthood with an atypical presentation. Approximately a quarter of autistic adults reported being misdiagnosed with at least one psychiatric condition before receiving an autism diagnosis. Personality disorders, mood disorders, and anxiety disorders were most frequently perceived as misdiagnoses, according to Fusar-Poli et al (2).
The contact between adult psychiatry and child and adolescent psychiatry, may be organized in transition care settings (outpatient care, clinical discussions, …). These practices may have a major impact in adult psychiatry practice, emphasizing the importance of a developmental approach, at any given time and with each patient, going beyond the classical inquiry about clinical and personal backgrounds. It also helps adult’s psychiatrists to keep in mind diagnostic hypotheses of neurodevelopmental disorders, which are usually more focused on child and adolescent psychiatry.
A clinical case will be presented to illustrate our thesis.
Diagnosing psychiatric disorders in individuals raised in orphanages is challenging due to symptom overlap. Trauma from institutional life can mimic symptoms of both Post-Traumatic Stress Disorder (PTSD) and paranoid schizophrenia (Hermenau et al. J Trauma Stress 2011; 24: 513-516). For example, PTSD symptoms like intrusive memories may resemble schizophrenia’s delusions when trauma affects threat perception. Additionally, PTSD-related attachment issues can exacerbate paranoia (Patel et al. J Trauma Dissociation 2016; 17: 123-136). Accurate diagnosis requires careful assessment of trauma history and symptom differentiation (Robinaugh et al. Depress Anxiety 2011; 28: 305-311).
Objectives
Challenges of symptoms overlapping in schizophrenia, borderline personality disorder, and PTSD.
Effects of orphanage background and early trauma on psychiatric symptoms.
Diagnostic methods and evolving treatment plans.
Methods
Patient ZN, a 37-year-old female with paranoid schizophrenia and borderline personality disorder (BPD), has had 11 admissions over six years at our clinic. Despite treatment with DSM-5 criteria, PANSS, and BEST scales, using antipsychotics, mood stabilizers, and benzodiazepines, there was no significant improvement. This year, her hospitalizations increased, particularly after developing a strong attachment and maternal feelings toward a doctor who treated her three times consecutively. PTSD, relevant due to her orphanage background and initially unassessed, was later identified through screening. Data were recorded through clinical notes, informed consent was obtained, and the case study’s single-case design limits generalizability.
Results
Conclusions
In conclusion, diagnosing PTSD, paranoid schizophrenia and BPD in orphanage-raised adults is challenging due to trauma, overlapping symptoms, and disrupted attachment. This case highlights the complexities of diagnosis and treatment, emphasizing the need for a comprehensive and adaptable approach.
In recent years, the appealing aspect of strength training has grown beyond its physical benefits, promoting interest in its potential impact on mental health. Despite the curiosity, the association between it and depression remains unexplored.
Objectives
The purpose of this study is to examine at the link between strength training intensity and depression levels among active gym-goers in Tunisia.
Methods
This is a cross-sectional study, conducted from February to March 2024. Participants were recruited online through social media platforms (Tunisian facebook groups and fitness forums) using a posted survey link. We’ve included respondents who are 18 years of age or older who have been active in strength training with a gym membership for 1 month or more. The respondents were required to answer a questionnaire that included questions related to socio-demographic data and to provide strength training intensity related details (sessions frequency, duration, perceived overall intensity using likert scale)
Depression levels were measured using the Patient Health Questionnaire-9 (PHQ-9).
Results
The overall number of participants was 72, with 86% being male. The majority of responders (n=65, 90.2%) indicated that they performed strength training exercises at least three times per week, with an average session length of 45 minutes. In terms of strength training intensity, 38.8% (n= 28) of participants reported high-intensity sessions, 48.6%(n=35) moderate-intensity sessions, and the remaining participants reported low-intensity sessions.
The mean depression score on the PHQ-9 scale was 4.3 (SD = 2.1). Implying a prevalence of minimal to mild depressive symptoms among the research population.
Strength training intensity was found to have a negative correlation with depression scores (r = -0.36, p = 0.03), suggesting that higher intensity sessions were linked with fewer symptoms of depression.
Conclusions
This study serves to shed light upon the association between strength training intensity and depression levels among Tunisian gym-goers. The findings emphasise the positive impact of strength training with higher intensity, on depressive symptoms
Cluster headache (CH) and bipolar disorder (BD) are cyclic disorders with shared clinical aspects, e.g. disturbed sleep patterns, response to lithium and a tendency to use illicit drugs.
Objectives
We investigated comorbidity of BD in patients with CH, prevalence of BD amongst CH family members, circadian aspects and use of illicit drugs.
Methods
Patients from the Leiden University Cluster headache neuro-Analysis program (LUCA) were screened cross-sectionally for BD online, using the Mood Disturbance Questionnaire (MDQ-NL) and Altman Self Rating Scale (ASRM-NL) and, if indicated, further evaluated with the Mini international neuropsychiatric interview (MINI). Circadian aspects were analyzed using the Circadian Type Inventory (CTI) and the Munich Chronotype Questionnaire (MCTQ).
Results
The life-time prevalence of BD in patients suffering from CH was 6.5%. Patients with comorbid BD (CH+BD) were more likely to have family members with BD (standardized OR= 1.50, 95% CI=1.15;1.95, p=0.003) and were more likely to suffer from chronic CH (OR=3.05 95% CI=1.18;7.87, p=0.02) after adjustment for age and sex. They also more often used illicit drugs, compared to patients with only CH. Circadian type and chronotype did not differ between the two groups after adjustment for confounders.
Conclusions
There is a high prevalence of BD in CH patients. CH+BD patients are more likely to have a positive family history for BD. CH+BD patients are more likely to suffer from chronic CH and more often use illicit drugs. In clinical practice it is important to screen for BD when treating patients with CH.
Depressive disorder is one of the health problems that carries the greatest burden of morbidity, with high prevalence and impact on people’s quality of life. It also affects the family environment and contributes to the social and economic burden on health systems (World Health Organization, depression, 2023). Currently, the treatment of depression has limitations and there is a high frequency of patients who do not respond despite multiple trials of antidepressants. Up to two-thirds of patients diagnosed with depression do not achieve remission despite treatment, and 30% of patients are considered treatment-resistant, defined as a minimum of two failures to previous treatments, in adequate doses and duration (Gaynes et al., 2019). Recent innovations in the management provide promising opportunities to improve the symptomatology of these patients. New drugs such as ketamine and esketamine, which have glutamatergic neuromodulatory properties, are used under supervision for the treatment of patients with treatment-resistant depression (Vasiliu, 2023).
Objectives
The aim is to describe a sample of real-world patients with a diagnosis of resistant depression referred to esketamine/ketamine treatment. The individuals were being followed by psychiatrists of a public hospital in the city of Barcelona and were selected to start treatment indicated by the refractoriness and severity of the episode.
Methods
We used a database that collected multiple sociodemographic, clinical and treatment variables of 32 patients with refractory depression who were referred to treatment with esketamine/ketamine. SPSS software was used for data processing. All the patients in the group were followed up by psychiatry in a public hospital in the city of Barcelona during the period from July 2015 to September 2024.
Results
Of the 32 patients evaluated, 11 were male (34.4%) and 21 were female (65.6%). The mean age at the time of receiving ketamine/ketamine treatment was 53 years with a standard deviation of 10.7. Nearly 60% had a comorbid psychiatric diagnosis. Twenty-eight percent had undergone electroconvulsive therapy. The mean number of previous episodes was 3.72 with a median of 2.5. Regarding the response to treatment we found that it was partial in 15 patients (46.9%) and complete remission could be obtained in 7 patients (21.9%), with no response to treatment in 10 of them (31.2%). In 5 patients the response was considered a late response.
Conclusions
In most of the patients a partial improvement was assessed as evidenced by a reduction in the Montgomery-Asberg Depression Rating Scale (MADRS). Few cases obtained a complete remission with treatment.
As limitations to the results, we can refer to the small sample size. However, we consider that the severity and chronicity of the episodes make the description of the response in a real world group seem of interest for future studies.
Although still somewhat reluctantly used (and thus underutilized) by many clinicians, it is the well-evidenced fact that clozapine is an effective drug for treatment-resistant schizophrenia. In order to optimize its therapeutic potential and to minimize side effects, therapeutic drug monitoring (TDM) of plasma clozapine and N-desmethylclozapine is an essential clinical tool. TDM can also help to reveal insufficient adherence or individual differences in the rates of metabolism. Moreover, clozapine plasma levels can be affected by other factor, such as smoking or concomitant medication (fluvoxamine). In our study sample, we were able to demonstrate the relationship between the dosage and clozapine plasma levels and their impact on clinical efficacy and safety.
Cognitive difficulties in people with psychosis are present at the time of the first episode, even from periods of high risk to early stages of psychosis, their nature and severity seem similar to those observed in patients with a more chronic evolution, since it seems to be an impairment that in most people remains stable, although there is a group of people that worsens. Therefore, these deficits cannot be fully explained by treatments, hospitalizations, or chronicity, and appear more as an intrinsic characteristic of the disease. The course of their trajectory through the progression of the disease remains uncertain.
Objectives
This study aimed to evaluate changes in cold, hot, and social cognition during acute psychotic episodes in hospitalized patients, to better understand their relationship with psychotic symptomatology.
Methods
A prospective longitudinal study was conducted with 10 patients (age range: 18-65) admitted to the psychiatric acute unit at Jerez de la Frontera Hospital, diagnosed with schizophrenia, schizoaffective disorder, or other psychotic disorders. Cognitive assessments included SCIP (cold cognition), Hinting Task (social cognition), and OSCARS (hot cognition), alongside psychiatric evaluations using PANSS, BPRS, and GAF scales. Statistical analysis was performed to identify correlations between cognitive domains and psychotic symptoms.
Results
Analysis of the 10 selected patients reveals that the levels of impairment in cold, warm, and social cognitive functions vary significantly. The mean obtained for the SCIP-S scale total (64.60) suggests a moderate impairment in cold cognition, which aligns with previous research indicating that this type of impairment is an intrinsic feature of psychotic disorders, regardless of the time course of the illness.The mean on the Hinting task (14.00) and OSCAR total score (52.60) reflect impairment in social and warm cognition, respectively. Regarding the PANSS scale, scores indicate a predominance of positive psychotic symptoms, with a mean of 31.50 on PANSS-P, suggesting a high degree of active symptomatology.
These results are congruent with the hypothesis that alterations in warm cognition could precede and perhaps influence the exacerbation of these psychotic symptoms, as has been suggested in previous studies.
Conclusions
This study provides preliminary evidence of the complex relationship between cold, warm, and social cognitive functions in patients with acute-phase psychotic disorder. The findings suggest that although these functions are impaired in psychosis, their interrelationship is not as strong as might be expected, underscoring the need for differentiated interventions that address each cognitive domain specifically.
Decision paralysis, defined as the inability to make decisions due to overwhelming options or uncertainty, is an often overlooked symptom of Attention-Deficit/Hyperactivity Disorder (ADHD). Individuals with ADHD frequently struggle with executive dysfunction, making it difficult to prioritize tasks, evaluate choices, and make timely decisions. Despite its significance, decision paralysis remains under-researched, particularly in terms of its impact on daily functioning and quality of life.
Objectives
This study aims to assess the prevalence and severity of decision paralysis in adults with ADHD, explore its relationship with executive dysfunction, and analyze its impact on various life outcomes such as career performance, interpersonal relationships, and overall well-being.
Methods
A total of 50 adults diagnosed with ADHD participated in this study. Self-report measures, including the Decision-Making Competence (DMC) scale and the ADHD Executive Dysfunction Questionnaire (AEDQ), were administered to assess participants’ decision-making difficulties, indecision, and executive functioning. Additional data were collected on life satisfaction, perceived stress levels, and the degree of daily functional impairment due to decision paralysis.
Results
The results indicate that 82% of participants reported frequent difficulties with decision-making, with 68% indicating that decision paralysis significantly affected their work performance. Decision paralysis was strongly correlated with executive dysfunction scores and was a significant predictor of reduced life satisfaction and increased perceived stress. Additionally, 74% of participants reported that indecision contributed to delays or avoidance in making important life choices, such as career changes or financial decisions, leading to long-term dissatisfaction. Notably, 58% of participants experienced decision paralysis at least once a week, with 35% reporting daily occurrences. Furthermore, 61% of participants indicated that decision paralysis led to missed opportunities in both personal and professional contexts, contributing to feelings of regret and frustration.
Conclusions
This study highlights the widespread impact of decision paralysis in adults with ADHD, significantly affecting both personal and professional domains. The strong correlation between decision paralysis and executive dysfunction suggests that addressing this symptom could be critical in improving quality of life for individuals with ADHD. Further research is needed to explore the development of specific interventions targeting decision paralysis.
Risperidone In Situ Microimplants (ISM®), a novel long-acting injectable (LAI) antipsychotic, rapidly achieves therapeutic plasma levels, with a significant first plasma peak occurring at 48 hours. This rapid onset of action, without the need for oral supplementation or loading doses, offers a promising new approach for effective management of acute symptoms (Walling et al. Drug Des Dev Ther 2021;15 4371-4382).
Objectives
To evaluate the efficacy and safety of risperidone ISM (R-ISM) in the treatment of acute manic episodes with psychotic symptoms, focusing on symptom change over time.
Methods
This preliminary and retrospective study included 15 inpatients with schizoaffective disorder who were started on R-ISM during a manic episode. RISM was administered after 6 days of oral risperidone. We retrospectively examined the Young Mania Rating Scale (YMRS) scores obtained in routine clinical practice at baseline (Dx), on the day of inpatient admission, on the day of injection (D0) and then 24 hours (D1), 48 hours (D2), 7 days (D8) and 28 days (D28) after the injection.
Results
A statistically significant improvement in the total YMRS score was observed as early as the day of injection, with the median score decreasing from 37 [IQR: 4.5] at baseline to 27 [IQR: 2.5] at D0 and further to 20 [IQR: 4] at 24 hours after the injection 1 (D1) (p < 0.01). The improvement remained statistically significant at all assessment time points, reaching 11 [IQR: 1.5] at day 28 (D28) (see Image 1).
Single-item analysis showed rapid and significant improvement across all YMRS items, in particular the following symptoms (see Image 2):
-Irritability: Significantly decreased from a score of 6 [IQR: 0] at baseline to 3 [IQR: 0.5] at D1 and to 1 [IQR: 0.5] at D28 (p < 0.01).
-Disruptive-Aggressive Behavior: Significantly decreased from a score of 3 [IQR: 2] at baseline to 1 [IQR: 1] at D1 and to 0 [IQR: 1] at D28 (p < 0.01).
-Sleep Disturbances: Significantly decreased from a score of 3 [IQR: 1] at baseline to 0 [IQR: 0.5] at D28 (p < 0.01).
-Speech (Rate and Amount): Significantly decreased from a score of 4 [IQR: 1] at baseline to 1 [IQR: 0] at D28 (p < 0.01).
-Content (Delusions; Hallucinations): Significantly decreased from a score of 6 [IQR: 0.5] at baseline to 3 [IQR: 1] at D28 (p < 0.01).
-Insight: Significantly decreased from a score of 3 [IQR: 2] at baseline to 2 [IQR: 1] at D28 (p<0.01).
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Conclusions
This preliminary and retrospective study suggests the possible efficacy of risperidone ISM (approved for schizophrenia) for acute manic episodes. However, due to the retrospective design of the study, the small sample size, and the presence of concomitant treatments, the results are primarily exploratory and no conclusions can be drawn until prospective, randomized, placebo-controlled trials are conducted.
Artificial intelligence (AI) language models are increasingly accessible tools that offer potential support in mental health care. Despite their promise in revolutionizing mental health care through symptom assessment and treatment suggestions, concerns about their validity, accuracy, ethical considerations, and risk management persist. This study evaluates the clinical reasoning capabilities of two leading AI language models in assessing a clinical case vignette of Major Depressive Disorder (MDD).
Objectives
To evaluate the diagnostic accuracy, risk assessment proficiency, and quality of treatment recommendations provided by ChatGPT and Claude when applied to a standardised clinical vignette of a case of MDD.
Methods
A clinical vignette describing a 50-year-old male patient exhibiting symptoms consistent with MDD was presented to both ChatGPT 4o and Claude 3.5 Sonnet. The patient had significant cardiac disease, leading to unemployment, social withdrawal, and passive suicidal ideation. Both AI models were asked five identical questions regarding: (1) diagnosis, (2) severity assessment, (3) first-line treatment recommendations, (4) optimal antidepressant selection, and (5) suicide risk evaluation. Two psychiatrists independently reviewed the responses for accuracy, comprehensiveness, and alignment with established guidelines and evidence-based treatment for depression with comorbid cardiac disease.
Results
Both AI models correctly diagnosed MDD and accurately recognized the severity of the case due to the presence of suicidal ideation and significant functional impairment. Both offered comprehensive treatment recommendations, including pharmacotherapy and psychotherapy, and specifically suggested Sertraline as the antidepressant of choice due to its favourable cardiac safety profile. Both models assessed the patient as having a moderate to high suicide risk and provided a reasonably thorough analysis of risk and protective factors. However, limitations were noted in their ability to incorporate individualized patient nuances and psychosocial factors fully.
Conclusions
ChatGPT 4o and Claude 3.5 Sonnet demonstrated significant capabilities in clinical reasoning, providing diagnoses and treatment recommendations that align with best clinical practices. Their responses were largely accurate and comprehensive, indicating potential utility as supportive tools for healthcare professionals. AI models may assist non-specialists in preliminary assessment and management but are not substitutes for professional psychiatric evaluation. Caution is advised in relying on AI for clinical decision making, and further refinement is necessary to enhance their ability to integrate patients-centered care and adherence to ethical guidelines, to mitigate risks associated with self-diagnosis and inappropriate treatment.
Eating disorders (ED) can sometimes present with psychotic symptoms, including delusions and cenesthetic or auditory hallucinations. In a minority of patients, these symptoms may stem from an underlying psychotic disorder, such as schizophrenia, which is more common in males (Bou Khalil R, Hachem D, Richa S. (2011). Eating disorders and schizophrenia in male patients: a review. Eat Weight Disord, 16(3), 150-6). Therefore, early detection and intervention are critical in cases where EDs are accompanied by prodromal or attenuated psychotic symptoms.
Objectives
To present the clinical case of a 14-year-old male with an unspecified eating disorder and high-risk mental state for psychosish
To highlight the importance of early identification and intervention in eating disorders with psychotic features.
Methods
A Pubmed database was used to collect information about psycothic symptoms in EDs, using the terms ‘eating disorder’, ‘pyscosis’ and ‘high risk mental state’.
We present the following clinical case:
A 14-year-old spanish male of Bolivian descent. The patient exhibited a two-year history of food restriction, vigorous exercise, social isolation, and absenteeism from school. Detailed clinical evaluations were performed, documenting his physical, psychological, and behavioral symptoms. The patient’s diagnosis was reevaluated based on emerging psychotic symptoms during hospitalization.
Results
The patient reported intense distress about perceived fat accumulation in his face and trunk, which he believed diminished immediately after exercise. He engaged in excessive physical activity, including jumping rope for at least two hours multiple times a day, and swimming against currents. He also experienced episodes of binge eating followed by purging and compensatory exercise. Social withdrawal, emotional blunting, disorganized biological rhythms, and soliloquies were observed during his admission. Based on these findings, his diagnosis was revised to an unspecified ED with a high-risk mental state for psychosis.
Conclusions
Psychotic symptoms, particularly in restrictive anorexia, can arise during the course of an ED, with malnutrition acting as both a cause and sustaining factor by exacerbating serotonin-dopamine dysregulation (Sarró, S (2018). Those courageous boys: 73 years after the Minnesota starvation experiment. A psychiatrist’s view. Neurosciences and History, 6(1), 28-37). While these symptoms may result from malnutrition, they could also signal the onset of a primary psychotic disorder, with males at higher risk (3.6%). Early detection of attenuated or prodromal psychotic symptoms is essential, and regular reevaluation is recommended, especially during the first months of follow-up, to prevent short-, medium-, and long-term complications.
The detection of electrophysiological markers to differentiate patients with suicide attempts could support the efforts of clinicians to provide proper diagnosis and treatment for them, and finally reduce the suicide mortality rate.
Objectives
The objective of the current study was to investigate and compare cortical functional networks from resting-state electroencephalogram in patients with suicide attempts and suicidal ideation using source-level weighted network analysis. We also examined the possibility of network features serving as biomarkers by differentiation between suicide attempts and suicidal ideation using machine learning techniques.
Methods
This study investigated source-level cortical functional networks using resting-state electroencephalography in drug-naïve depressed patients with suicide attempt and suicidal ideation. Electroencephalogram was recorded in 55 patients with suicide attempts and in 54 patients with suicidal ideation. Graph-theory-based source-level weighted functional networks were assessed using strength, clustering coefficient (CC), and path length (PL) in seven frequency bands. Finally, we applied machine learning to differentiate between the two groups using source-level network features.
Results
There were significant differences in the three global level indices of the high alpha band. The strength and CC of the high alpha band were significantly lower in patients with suicide attempts than in those with suicide attempts ideation. In contrast, the PL of the high alpha band was significantly higher in patients with suicide attempts than in those with suicide ideation. No significant differences in the other frequency bands were between the two groups.
The nodal CCs of patients with suicide attempts were significantly lower than those of patients with suicide ideation in most regions, except for three of the 68 regions.
The best classification performance between suicide attempts and suicide ideation was an accuracy of 73.39%, a sensitivity of 76.36%, and a specificity of 70.37% with 17 features. Three of these features were global-level network indices (strength, CC, and PL) in the high alpha band; the other 14 features were high alpha band nodal level CCs in limbic, frontal, temporal, parietal,and occipital area.
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Conclusions
This is the first study to use electroencephalogram source level network measures, revealing that network indices for high alpha band could be potential biomarkers to distinguish betweensuicide attempts and suicide ideation in patients with depression. Moreover, our study evaluated the electroencephalogram signals immediately after fatal suicide attempts in a relatively large number of un-medicated patients.