Off–label long acting injectable antipsychotics in real–world clinical practice: a cross-sectional analysis of prescriptive patterns from the STAR Network DEPOT study

Introduction: Information on the off–label use of Long–Acting Injectable (LAI) antipsychotics in the real world is lacking. In this study, we aimed to identify the sociodemographic and clinical features of patients treated with on– vs off–label LAIs and predictors of off–label First– or Second–Generation Antipsychotic (FGA vs. SGA) LAI choice in everyday clinical practice. Method: In a naturalistic national cohort of 449 patients who initiated LAI treatment in the STAR Network Depot Study, two groups were identified based on off– or on–label prescriptions. A multivariate logistic regression analysis was used to test several clinically relevant variables and identify those associated with the choice of FGA vs SGA prescription in the off–label group. Results: SGA LAIs were more commonly prescribed in everyday practice, without significant differences in their on– and off–label use. Approximately 1 in 4 patients received an off–label prescription. In the off–label group, the most frequent diagnoses were bipolar disorder (67.5%) or any personality disorder (23.7%). FGA vs SGA LAI choice was significantly associated with BPRS thought disorder (OR = 1.22, CI95% 1.04 to 1.43, p = 0.015) and hostility/suspiciousness (OR = 0.83, CI95% 0.71 to 0.97, p = 0.017) dimensions. The likelihood of receiving an SGA LAI grew steadily with the increase of the BPRS thought disturbance score. Conversely, a preference towards prescribing an FGA was observed with higher scores at the BPRS hostility/suspiciousness subscale. Conclusion: Our study is the first to identify predictors of FGA vs SGA choice in patients treated with off–label LAI antipsychotics. Demographic characteristics, i.e. age, sex, and substance/alcohol use co–morbidities did not appear to influence the choice towards FGAs or SGAs. Despite a lack of evidence, clinicians tend to favour FGA over SGA LAIs in bipolar or personality disorder patients with relevant hostility. Further research is needed to evaluate treatment adherence and clinical effectiveness of these prescriptive patterns

Comparing Long-Acting Antipsychotic Discontinuation Rates Under Ordinary Clinical Circumstances: A Survival Analysis from an Observational, Pragmatic Study

Background: Recent guidelines suggested a wider use of long-acting injectable antipsychotics (LAI) than previously, but naturalistic data on the consequences of LAI use in terms of discontinuation rates and associated factors are still sparse, making it hard for clinicians to be informed on plausible treatment courses. Objective: Our objective was to assess, under real-world clinical circumstances, LAI discontinuation rates over a period of 12 months after a first prescription, reasons for discontinuation, and associated factors. Methods: The STAR Network ‘Depot Study’ was a naturalistic, multicentre, observational prospective study that enrolled subjects initiating a LAI without restrictions on diagnosis, clinical severity or setting. Participants from 32 Italian centres were assessed at baseline and at 6 and 12 months of follow-up. Psychopathology, drug attitude and treatment adherence were measured using the Brief Psychiatric Rating Scale, the Drug Attitude Inventory and the Kemp scale, respectively. Results: The study followed 394 participants for 12 months. The overall discontinuation rate at 12 months was 39.3% (95% confidence interval [CI] 34.4–44.3), with paliperidone LAI being the least discontinued LAI (33.9%; 95% CI 25.3–43.5) and olanzapine LAI the most discontinued (62.5%; 95% CI 35.4–84.8). The most frequent reason for discontinuation was onset of adverse events (32.9%; 95% CI 25.6–40.9) followed by participant refusal of the medication (20.6%; 95% CI 14.6–27.9). Medication adherence at baseline was negatively associated with discontinuation risk (hazard ratio [HR] 0.853; 95% CI 0.742–0.981; p = 0.026), whereas being prescribed olanzapine LAI was associated with increased discontinuation risk compared with being prescribed paliperidone LAI (HR 2.156; 95% CI 1.003–4.634; p = 0.049). Conclusions: Clinicians should be aware that LAI discontinuation is a frequent occurrence. LAI choice should be carefully discussed with the patient, taking into account individual characteristics and possible obstacles related to the practicalities of each formulation

The Role of Attitudes Toward Medication and Treatment Adherence in the Clinical Response to LAIs: Findings From the STAR Network Depot Study

Background: Long-acting injectable (LAI) antipsychotics are efficacious in managing psychotic symptoms in people affected by severe mental disorders, such as schizophrenia and bipolar disorder. The present study aimed to investigate whether attitude toward treatment and treatment adherence represent predictors of symptoms changes over time. Methods: The STAR Network \u201cDepot Study\u201d was a naturalistic, multicenter, observational, prospective study that enrolled people initiating a LAI without restrictions on diagnosis, clinical severity or setting. Participants from 32 Italian centers were assessed at three time points: baseline, 6-month, and 12-month follow-up. Psychopathological symptoms, attitude toward medication and treatment adherence were measured using the Brief Psychiatric Rating Scale (BPRS), the Drug Attitude Inventory (DAI-10) and the Kemp's 7-point scale, respectively. Linear mixed-effects models were used to evaluate whether attitude toward medication and treatment adherence independently predicted symptoms changes over time. Analyses were conducted on the overall sample and then stratified according to the baseline severity (BPRS < 41 or BPRS 65 41). Results: We included 461 participants of which 276 were males. The majority of participants had received a primary diagnosis of a schizophrenia spectrum disorder (71.80%) and initiated a treatment with a second-generation LAI (69.63%). BPRS, DAI-10, and Kemp's scale scores improved over time. Six linear regressions\u2014conducted considering the outcome and predictors at baseline, 6-month, and 12-month follow-up independently\u2014showed that both DAI-10 and Kemp's scale negatively associated with BPRS scores at the three considered time points. Linear mixed-effects models conducted on the overall sample did not show any significant association between attitude toward medication or treatment adherence and changes in psychiatric symptoms over time. However, after stratification according to baseline severity, we found that both DAI-10 and Kemp's scale negatively predicted changes in BPRS scores at 12-month follow-up regardless of baseline severity. The association at 6-month follow-up was confirmed only in the group with moderate or severe symptoms at baseline. Conclusion: Our findings corroborate the importance of improving the quality of relationship between clinicians and patients. Shared decision making and thorough discussions about benefits and side effects may improve the outcome in patients with severe mental disorders

The Rorschach Test and Perpetrators of Homicide

Learning Overview: —just as in any other human behavior—is a reflection of one’s Impact on the Forensic Science Community: Objective: The hypothesis of this study is that it is possible to identify correlations between certain aspects of mental functioning in addition to criminological and forensic variables that are closely related to a crime. Moreover, this study hypothesized that a trace of this correlation exists in the Rorschach test. The existence of a correlation between aspects of personality and crime has been theorized and that criminal activity reflects the personality traits of the perpetrator, his life, and the way he interacts with the world around him. Investigative psychology was born and developed on the assumption that behaviors expressed during an act of aggression, the choice of the victim, and the mode of action is, in some way, connected to the personal history of the aggressor and to his mental and behavioral functioning, in addition to the quality of his relationships. Methods: This study examined the Rorschach protocols administered to a sample of homicide perpetrators who underwent psychiatric examination as ordered by Judicial Authorities to ascertain the ability of the subjects to understand their intent and will at the time the crime was committed. These data were taken from the database of the Section of Criminology and Forensic Psychiatry of the University of Bari, Italy, from 1998 to 2014. The goal of this study was to identify psychometric and psychodiagnostic variables associated with characteristics of the crime committed and correlate them to the crime scene, describing them as either “organized” or “disorganized.” The sample consisted of 49 subjects—43 males (87.7%), and 6 females (12.2%), 24 unmarried (48.9%), 21 married (42.9%), and 4 separated (8.2%). Education levels ranged from 0 years (5 subjects, 10.2%) to 13 years (9 subjects, 18.4%), while the majority had an education level of five years (15 cases, 30.6%), and eight years (20 cases, 40.8 %). Twenty-four subjects were between 25 and 44 years old (48.9%), and 11 subjects were between 45 and 54 years old (22.4%). Eleven subjects were between 55 and 64 years old (22.4%); two of the subjects were minors, and one was older than 65 years of age. Eight of the subjects had no previous psychiatric diagnoses (16.3%). The following psychiatric diagnoses were formulated for the remaining 41 subjects (83.7%): 13 schizophrenia, 1 delusional disorder, 1 bipolar disorder, 5 depression, 4 psychoorganic syndrome, 13 personality disorder, and 4 limited intellectual functioning. The results of this psychiatric report indicated that 23 (46.9%) subjects were recognized as fully chargeable, 10 subjects (20.4%) were shown to have a partial defect of mind, and 16 subjects (32.6%) were shown to have a total defect of mind. The means used to carry out the offenses are as follows: 15 (30.6%) used a sharp object or cutting weapon, 12 (24.5%) used a firearm, 8 (16.3%) resorted to physical assault, 6 (12.2%) used asphyxiation, and 8 (16.3%) through other various means (3 stoning, 3 precipitation, 2 by means of an automobile). In 14 cases (28.6%), the murder was considered “premeditated.” In the remaining 35 (71.4%), the homicides were found to be “impromptu and not premeditated.” In 31 cases (63.3%), the crime scene was described as “organized.” In 16 cases (32.6%), the crime scene was described as “disorganized.” Results: The Rorschach test has been confirmed as a particularly effective and sensitive tool in the study of normal and pathological personalities, including within the field of forensic psychiatry, when it is rigorously applied to standardized, reliable, and validated methods of administration, labeling, and evaluation, in addition to the use of representative samples of normal subjects. It is particularly evident that some of the Rorschach indices may be significantly correlated with the crime scenes that are described as “organized” and “disorganized.” Conclusion: This study has confirmed how the Rorschach test, which is certainly useful in the clinical study of thought functioning, the examination of reality, affectivity, and of the ability to correctly represent oneself and others in relationships, can offer one psychic split that may also play another important role in the field of forensics

Naloxone-induced decrease of plasma prolactin in healthy women

Twenty-eight healthy volunteers (12 males and 16 females) received naloxone hydrochloride (2 mg i.v. as a bolus) and saline on two different days, according to a double-blind design. Blood samples were collected at time 0 and 30, 60, 120, 180, 240, and 320 minutes after the injection. Plasma PRL levels were estimated by the radioimmunoassay method. Statistical evaluation indicates significant variation of plasma PRL levels only in women. Possible reasons are discussed

A naturalistic study on the relationship among resilient factors, psychiatric symptoms, and psychosocial functioning in a sample of residential patients with psychosis

 Nicola Poloni, Daniele Zizolfi, Marta Ielmini, Roberto Pagani, Ivano Caselli, Marcello Diurni, Anna Milano, Camilla Callegari Department of Medicine and Surgery, Division of Psychiatry, University of Insubria, Varese, Italy Objective: Resilience is a multidimensional process of adaptation aimed to overcome stressful or traumatic life experiences; only in the last few years it has been considered as a personal resource in psychosis and schizophrenia. This study aimed to assess the relationship between intrapersonal and interpersonal resilience factors and schizophrenia, particularly whether and how resilience can improve the course of psychotic illness. Patients and methods: In this observational study, all patients recruited had to fulfill the following inclusion criteria: diagnosis of schizophrenia spectrum disorder (Diagnostic and Statistical Manual of Mental Disorders-5); aged between 18 and 65 years; provided written informed consent; to be clinically stable (Clinical Global Impression Scale <3); history of illness ≥5 years; to be compliant with antipsychotic therapy over the last year; and regular submission to periodic monthly psychiatric visits. Patients were evaluated through the following scales: Resilience Scale for Adults (RSA) for resilience; Brief Psychiatric Rating Scale-Anchored version (BPRS-A), Scale for the Assessment of Negative Symptoms (SANS), and Scale for the Assessment of Positive Symptoms (SAPS) for psychotic symptomatology; and Life Skills Profile (LSP) for psychosocial functioning. ­Statistical analysis was performed by SPSS. Partial correlations were evaluated to assess the relationship between RSA total scores and subscores and BPRS-A, SANS, SAPS, and LSP total scores, removing the common variance among variables. Then, a series of hierarchical multiple linear regression models were used to examine the association between resilience, psychopathology, and psychosocial functioning. Results: A statistically significant negative correlation among intrapersonal resilience factors and BPRS-A total score emerged, predicting psychiatric symptoms severity and explaining approximately 31% of the BPRS-A variance; otherwise, only the interpersonal resilience factors associated with social support were statistically and positively correlated with LSP total score, predicting psychosocial functioning and explaining the 11% of LSP variance. Conclusion: The specific contribution that resilience factors may have in predicting the severity of symptoms and the extent of psychosocial functioning emphasizes the importance of personalizing treatment for patients affected by schizophrenia, promoting personal resources, and translating them into better outcomes. Keywords: resilience, personal resources, psychosis, schizophrenia, residential patients, psychosocial functionin