A. Ballerini

Plasma Levels and Clinical Response during Treatment with Clomipramine

The plasma levels of clomipramine (CI) and its major metabolite desmethylclomipramine (DMCI) may be related to clinical response during treatment of depression. Not all workers have been able to demonstrate such a relationship. The many factors which may affect clinical response include sample selection, assessment and its quantification and kinetic factors. A further investigation into the relationship between plasma levels and response was, therefore, carried out taking these into account and attempting to control them. Sixty-two patients with depressive illness were included. The plasma levels of CI + DMCI as measured on the 28th day of treatment were correlated against clinical response at the time. Patients with the highest combined plasma levels showed the best response. Patients with intermediate plasma levels showed more modest response, whilst lowest plasma levels tended to be shown by patients who exhibited an inadequate response or who relapsed during subsequent outpatient follow-up. The threshold value for satisfactory antidepressant effect appeared to be a combined CI + DMCI plasma level of 160-200 mg/ml.

Model of Management (Mo.Ma) for the patient with schizophrenia: crisis control, maintenance, relapse prevention, and recovery with long-acting injectable antipsychotics (LAIs)

INTRODUCTION Schizophrenia is a severe mental disease that affects approximately 1% of the population with a relevant chronic impact on social and occupational functioning and daily activities. People with schizophrenia are 2-2.5 times more likely to die early than the general population. Non-adherence to antipsychotic medications, both in chronic and first episode schizophrenia, is one of the most important risk factors for relapse and hospitalization, that consequently contributes to increased costs due to psychiatric hospitalization. Atypical long-acting injectable (LAI) antipsychotics can improve treatment adherence and decrease re-hospitalization rates in patients with schizophrenia since its onset. The primary goals in the management of schizophrenia are directed not only at symptom reduction in the short and long term, but also at maintaining physical and mental functioning, improving quality of life, and promoting patient recovery. AIM To propose a scientific evidence-based integrated model that provides an algorithm for recovery of patients with schizophrenia and to investigate the effectiveness and safety of antipsychotics LAI in the treatment, maintenance, relapse prevention, and recovery of schizophrenia. METHODS After an accurate literature review we identified, collected and analyzed the crucial points in taking care schizophrenia patients, through which we defined the steps described in the model of management and the choice of the better treatment option. Results. In the management model we propose, the choice of a second generation long acting antipsychotic, could allow from the earliest stages of illness better patient management, especially for young individuals with schizophrenia onset, a better recovery and significant reductions of relapse and health care costs. LAI formulations of antipsychotics are valuable, because they help patients to remain adherent to their medication through regular contact with healthcare professionals and to prevent covert non-adherence. CONCLUSIONS The proposed schizophrenia model of management could allow better patient management and recovery, in which the treatment with LAI formulation is a safe and effective therapeutic option. This new therapeutic approach could change the cost structure of schizophrenia by decreasing costs with efficient economic resource allocation guaranteed from efficient diagnostic and therapeutic pathways.

The effects of switching from oral to LAI antipsychotic treatment on subjective experience of schizophrenic and schizoaffective patients: Preliminary results

Abstract Objective. To present real-world preliminary evidence on the specific effects of switching from oral to long-acting injectable (LAI) antipsychotic treatment on patients subjective experience and quality of life (QoL) in a sample of clinically stable psychotic subjects. Methods. Twenty-six clinically stable adult schizophrenic and schizoaffective outpatients were recruited. All patients were under a stabilized therapy with a single oral second-generation antipsychotic and were switched to the equivalent maintenance regimen with the long-acting formulation of the same antipsychotic. Two subgroups of patients were created on the basis of the presence/absence of a complete clinical remission at enrollment. Anthropometric (body mass index), psychometric (Montgomery–Asberg Depression Rating Scale, Young Mania Rating Scale, and Positive And Negative Syndrome Scale), and patients reported outcome (Subjective Well-Being Under Neuroleptics scale short form, Drug Attitude Inventory short version, and Short Form-36 health survey) data were collected at enrollment (T0) and after 6 months from the treatment switch (T1). Results. Significant improvements in psychometric indexes, and patients’ subjective experience of treatment and attitudes toward drug (reflecting in an enrichment of patients’ health-related QoL) were found both in initial remitters and non-remitters. Conclusions. Our preliminary results suggest that the switch from oral to LAI antipsychotic treatment may help to address the subjective core of an optimal and satisfying recovery of psychotic patients. Size and duration of this study need to be expanded in order to produce more solid and generalizable results.

Optic neuropathy due to nutritional deficiency in a male adolescent with Avoidant/Restrictive Food Intake Disorder: a case report

The DSM-5 diagnostic criteria for Avoidant/Restrictive Food Intake Disorder (ARFID) describes a cohort of patients who exhibit restrictive or avoidant eating behaviors. These behaviors often result in significant weight loss, growth compromise, a reliance on nutritional supplements to meet daily energy requirements, nutritional deficiency (e.g., iron deficiency anemia) and/or marked interference with the patient’s psychosocial functioning. Patients with ARFID do not fear weight gain, are not dissatisfied with their body weight, shape, or size, and lack any cognitions typically associated with Anorexia Nervosa (AN). The aim of the present case report is to expand awareness on ARFID, discussing a patient with multiple comorbidities and a particular clinical presentation.

Predictive factors of overall functioning improvement in patients with chronic schizophrenia and schizoaffective disorder treated with paliperidone palmitate and aripiprazole monohydrate

Long‐acting injectable (LAI) antipsychotics can improve medication adherence and reduce hospitalisation rates compared with oral treatments. Paliperidone palmitate (PAL) and aripiprazole monohydrate (ARI) LAI treatments were associated with improvements in global functioning in patients with schizophrenia.

Relationship Between Aberrant Salience, Psychotic Symptoms and Pharmacological Treatment in a Follow-up Study: is the Salience a Lifetime Trait?

Introduction Aberrant salience is the incorrect assignment of salience, significance or value to different innocuous stimuli. It seems closely related with dysregulation of the dopamine system that in turn relates with proneness to develop psychosis. Objectives To evaluate aberrant salience processing in a clinical trans-diagnostic sample, its relationship with anamnestic psychotic symptoms and current psychopathology, and possible variations of aberrant salience after three months of clinical-based treatment. Methods Twenty inpatient subjects attending the Psychiatric Unit (Florence University) were recruited: 3 with Major Depression Disease, 6 with Schizophrenia, 3 with Bipolar Disorder, 4 with Obsessive-Compulsive Disorder, 4 with Eating Disorders. Patients were assessed by means of a clinical interview (SCID-I/P) and several questionnaires (AMDP, MADRS, HAM-A, MRS, PANSS and Aberrant Salience Inventory-ASI) at enrolment (T0) and after an individual and clinical-based treatment lasting 3 months (T1). Results At T0 subjects with positive ASI (cut-off>14) reported more frequently past and lifetime psychotic symptoms (p Conclusion Aberrant salience is significatively associated to lifetime psychotic symptoms. It represents a relevant psychopathologic dimension that, unlike other symptoms, seems not to significatively modify after pharmacological treatment and could represent a stable lifetime.

Coping with Neuropsychiatric Side Effects of Pegylated Interferon Alpha Therapy in Hepatitis C Virus Positive (HCV+) Patients: an Observational Study.

Background HCV is the most frequent cause of chronic hepatitis and a risk factor for liver cirrhosis and hepatocellular carcinoma. Despite recent advances in HCV therapy, Pegylated Interferon Alpha (PegIFNα) remains the treatment backbone, even if it can cause serious neuropsychiatric symptoms (from irritability to psychosis) that could reduce treatment compliance to the point of failure. Aims To describe the neuropsychiatric symptoms during PegIFNα treatment in a group of HCV patients without any psychiatric morbidity at enrolment, and drop-out rate. Methods Eleven HCV+ outpatients, scheduled for PegIFNα treatment, were assessed at enrolment (T0), and after one (T1) and two months (T2) to investigate psychiatric symptoms by means of SCID-I, HAM-D, HAM-A, PHQ-9, MDRS and MRS. A pharmacological therapy, based on clinical evidence, were provided at their onset. Results Comparing T0, T1 and T2 mean scores, we found a increasing trend in all psychometric scales, statistically significant for HAM-D and HAM-A. An item-by-item analysis showed a significative increase in the mean scores of HAM-D somatic items (#11 to 14), and HAM-A Anxious mood(#1), Tension(#2) and somatic items (#8 to 10, 12, 13). Drop-up occurred in two outpatients (18%), both after T1 assessment, due to HCV relapse (one patient), and serious somatic side effects (one patient). Conclusions Patients at early stages of PegIFNα treatment may develop a psychiatric comorbidity, particularly tension, anxiety and somatic symptoms, even without a psychiatric hystory. This confirmes a need for psychiatric assessment in patients scheduled for antiviral therapy, to identify early symptoms and reduce drop-out rates.

EPA-1128 – Long-acting second-generation antipsychotics: Improving subjective experience of pharmacological treatment and quality of life

Introduction Long-acting injectable (LAI) antipsychotics have been used as an alternative to oral antipsychotic formulations. Aims to evaluate the impact of switching to a LAI second-generation antipsychotic (SGA) in terms of changes in patients psychopathology, subjective experience of drug and quality of life. Methods 18 adult outpatients diagnosed with Schizoaffective disorder (by means of the SCID-I/P) and attending the Psychiatric Unit of the University of Florence were recruited. All patients were under a stabilized therapy with a single oral SGA (either olanzapine or paliperidone) and were switched to its corresponding LAI formulation (olanzapine pamoate or paliperidone palmitate). Patients were assessed by means of the following questionnaires: MADRS, YMRS, PANSS, DAI-10, SWN and SF-36 at enrolment (T0) and after 6 months (T1). Results A significant reduction was found between T0 and T1 (p Conclusions Treatment with LAI SGAs seems to be a valid alternative in patients with Schizoaffective disorder. Our preliminary data suggest an improvement in patients subjective experience of pharmacological therapy and health-related quality of life, together with a similar efficacy on psychopathology.

1360 – Long acting second generation antipsychotic therapy, from compliance to improving quality of life: the florence depot clinic preliminary report

Introduction Long acting injectable “depot” preparations of antipsychotic medications have been used as an alternative to oral medication therapy for patients with low adherence to therapy. Nowadays the use of long acting second generation antipsychotic therapy is focused on improving quality of life and patients’ subjective experience of drug therapy. Objectives and aims To evaluate the impact of long acting second generation antipsychotic therapy on patients’ psychopathology, quality of life, subjective experience of drug and cognitive performance. Methods 20 adult male and female outpatients aged 21-53 attending the Psychiatric Unit of the University of Florence under therapy with oral second generation antipsychotics were recruited and were switched to long acting second generation antipsychotics (Zypadhera, Risperdal depot and Xeplion). Patients were assessed by means of Psychometric Tests, Neurocognitive Tests and blood tests at recruitment, after 6 months and after 12 months. Results A first clinical evaluation is indicating an improvement in quality of life especially regarding patients’ subjective experience of drug and a decrease of side effects like sedation and blunted affect. Furthermore, preliminary data show a reduction of bodyweight in patients who initially gained weight during oral antipsychotic therapy. Conclusions Long acting second generation antipsychotic therapy seems to be a valid alternative in patients who have been stabilized on oral antipsychotics, since it has a similar efficacy and furthermore it offers a better quality of life by reducing side effects of oral antipsycotics.

1029 – Relationship between aberrant salience processing and psychotic symptoms in a clinical trans-diagnostic sample: preliminary data

Introduction Aberrant salience consists of the unusual or incorrect assignment of salience, significance or value to different innocuous stimuli. It has been hypothesized that subjects with an aberrant salience could be proneness to develop psychosis. Despite the importance of this concept in psychosis, only few instruments assess aberrant salience. Objectives and aims To evaluate aberrant salience processing in a clinical trans-diagnostic sample and its relationship with psychotic symptoms. Methods Thirty-six outpatient subjects attending the Psychiatric Unit of the University of Florence were recruited: 9 with Major Depression Disease (MDD), 8 with Schizophrenia (SC), 19 with Bipolar Disorder (BD). Patients were assessed by means of a clinical interview (SCID-I/P) and several questionnaires, including the Aberrant Salience Inventory (ASI). Results The three groups showed significant differences in the lifetime presence of psychotic symptoms, with higher frequency in BD and SC patients (p 14) reported more frequently past and lifetime psychotic symptoms (p Conclusion Aberrant salience is significantly associated to lifetime psychotic symptoms. Thus it represents a relevant psychopathologic dimension that requires a careful investigation in patients with an history of psychotic events. The ASI could represent an useful instrument to evaluate the proneness of clinical and pre-clinical samples to develop psychotic symptoms.