Side Effects Scale Research Articles

Rituximab as an adjunctive treatment for schizophrenia spectrum disorder or obsessive-compulsive disorder: Two open-label pilot studies on treatment-resistant patients

In this explorative study, we investigated if an adjunctive treatment with one single dose of the monoclonal antibody rituximab would improve symptoms and function in treatment-resistant patients with schizophrenia spectrum disorder (SSD, n = 9) or obsessive-compulsive disorder (OCD, n = 10), based on the inflammatory hypothesis for mental disorders. Patients were followed for one year. Disability was measured with the Personal and Social Performance score (PSP). At baseline, the mean PANSS score in the SSD group was 99 ± 32 and the mean Y-BOCS score in the OCD group was 27.5 ± 7. Mean PSP scores were 32 ± 10.2 and 42.5 ± 9.9 in the SSD and OCD groups, respectively. Seven had Paediatric Acute-Onset Neuropsychiatric Syndrome (PANS) in retrospect, and 3 SSD patients had schizo-obsessive subtype. 4/8 SSD patients showed a ≥40% reduction in PANSS at endpoint I week 20, however, 7/9 were similarly improved already at week 12. Among the OCD patients, 2/10 showed a ≥35% reduction in Y-BOCS at week 20. Disability was significantly improved only in the SSD group. The percentual decrease of PANSS scores in SSD patients was associated with the increase in immunoglobulin levels week 20 (n = 8: IgG r = 0.85, p = .007; IgA r = 0.79, p = .019; IgM r = 0.73, p = .038).Rituximab was generally well tolerated in these patients. Self-rated improvements since baseline were reported for psychic (p = .021), neurological (p = .059), and autonomic (p < .001) side effects (UKU-SERS-Pat side-effect scale). Anxiety was commonly reported by OCD patients, while an initial increase in psychotic symptoms was seen in a few SSD patients. An RCT is underway to evaluate rituximab in SSD.

Relationship of serum homocysteine and vitamin D with positive, negative, and extrapyramidal symptoms in schizophrenia: a case–control study in Iran

BackgroundSchizophrenia is a devastating condition characterized by frequent recurrences, cognitive decline, and emotional and functional disabilities. This condition includes positive and negative symptoms and cognitive impairments resistant to drug treatment. According to studies, many biomarkers can affect this disorder. However, there is little information about vitamin D and homocysteine levels in patients with disease complications. We aimed to investigate this relationship in schizophrenia.MethodIn this case–control study, 33 patients with schizophrenia and 33 healthy individuals were enrolled from Golestan, the north of Iran, in 2021. Blood samples were taken from all participants to assess vitamin D and homocysteine serum levels. In addition, schizophrenic patients completed the Positive And Negative Syndrome Scale (PANSS) and Simpson-Angus Extrapyramidal Side Effects Scale (SAS). Data analysis was performed at a significance level of 0.05 using SPSS 16 software.ResultsOf the 66 participants, 66.7% had vitamin D deficiency, and 71.2% had normal homocysteine levels. However, the serum level of vitamin D was lower in schizophrenic patients than in controls (p = 0.035), and serum homocysteine levels were higher in the schizophrenic group than in controls (p < 0.001). Vitamin D levels in patients with schizophrenia were significantly correlated with the overall assessment of extrapyramidal symptoms (r = 0.35, p = 0.04). However, no significant relationship existed between vitamin D and homocysteine levels and PANSS results (p > 0.05).ConclusionSerum levels of vitamin D and homocysteine were significantly lower and higher in schizophrenic patients than in the control group. Improvement of extrapyramidal symptoms in schizophrenic patients had a direct and significant relationship with serum vitamin D.

Homoeopathic Add-On Treatment in Schizophrenia—A Case Report

Abstract Introduction Schizophrenia is a chronic disabling disease which requires lifelong treatment. Antipsychotics are the mainstay of treatment as of now, which are very expensive and known to cause many side effects. It would be favourable if alternative treatment options like homeopathy are brought into limelight in the treatment of schizophrenia. Very sparse literature is available evaluating the utility of individualised homoeopathic medicine in the this condition. Methods A 33-year-old woman presenting with symptoms of schizophrenia and under conventional medication was treated during a period of April 2019 to October 2020. Individualised homoeopathic medicine was prescribed as add-on therapy. Outcomes were assessed using Positive and Negative Syndrome Scale. Side effects of antipsychotics were assessed using Glasgow Antipsychotics Side-effects Scale. Modified Naranjo Criteria was used to assess whether the changes were likely to be associated with the homoeopathic intervention. Results A beneficial result was obtained from individualised homoeopathic treatment. The antipsychotic medication was stopped within 9 months of treatment. Conclusion More studies with large sample size are required to provide additional support to this study.

Interleukin-6 in schizophrenia is associated with negative symptoms, side effects of therapy and smoking: results of a pilot study

Interleukin-6 (IL-6) is one of the most important pro-inflammatory markers with immunomodulatory activity associated with schizophrenia. The possible involvement of interleukin-6 in the etiopathogenesis of schizophrenia and the development of different clusters of symptoms remains debatable; the relationship between an increase in interleukin-6 and a number of possible confounding factors, including smoking, has not yet been studied. The aim of this work was the pilot evaluation of the serum IL-6 level in patients with schizophrenia compared with healthy controls, as well as its association with clinical symptoms, socio-demographic factors and smoking. Materials and methods: 43 patients with schizophrenia and 24 healthy volunteers were examined. The determination of IL-6 was carried out by enzyme immunoassay. All patients were assessed using the Positive and Negative Schizophrenia Syndrome Scale (PANSS), The UKUSERS-Clin Therapeutic Side Effects Scale (UKU), Simpson-Angus Scale (SAS), the Abnormal Involuntary Movements Scale (AIMS), Barnes Akathisia Scale (BARS), Personal and Social Functioning Scale (PSP). Results: In patients with schizophrenia in a Russian sample, serum IL-6 levels were significantly associated with smoking status (p = 0.0017), the severity of negative symptoms and symptoms of the PANSS general psychopathology scale (p=0.014 and p=0.038, respectively), disorders of personal and social functioning (PSP, p=0.011), as well as side effects measured using the UKU scale (general, p=0.038, 0041 and extrapyramidal, p=0.018), as well as drug-induced parkinsonism (p=0.043), dyskinesia (p=0.0084) and akathisia (p=0.043). All scores are worse in patients with nicotine addiction. The occurrence of extrapyramidal symptoms (EPS) in response to standard doses of antipsychotics (AP) can serve as a clinical marker of possible immune-inflammatory disturbances in patients with schizophrenia, and the smoking status can act as a provocing factor for increasing of latent inflammation. Replication of the study is required to confirm the findings.

Validation of the Glasgow Antipsychotic Side-Effect Scale (GASS) in an Italian Sample of Patients with Stable Schizophrenia and Bipolar Spectrum Disorders.

Antipsychotics are a class of psychotropic drugs that improve psychotic symptoms and reduce relapse risk. However, they may cause side effects (SE) that impact patients’ quality of life and psychosocial functioning. Therefore, there is a need for practical tools to identify them and possibly intervene. The objective of the present study was to translate into Italian the Glasgow Antipsychotic Side Effect Scale (GASS), which is suggested as the questionnaire of choice to collect SE reported by patients treated with antipsychotics. We administered the GASS and the Udvalg for Kliniske Undersøgelser (UKU) SE scale—which is considered the gold standard—to 100 stable patients with schizophrenia and bipolar spectrum disorders. We measured the structural validity, internal consistency, concurrent criterion validity, construct validity, and clinical feasibility. GASS was characterized by modest structural validity and good internal consistency. The binary correlations concerning the presence of specific symptoms investigated with the GASS and the UKU were strong or relatively strong for only half of them. The GASS total scale score was inversely related to patients’ quality of life and psychosocial functioning. The GASS is useful to briefly assess the burden of antipsychotic SE (~5 min) but is not optimal in identifying them.

Homoeopathy as an add-on treatment for schizophrenia - A case series

Introduction: Schizophrenia is a complex, progressive and severe mental disorder characterised by distortions in thinking, perception, emotions, language, sense of self and behaviour. Conventional medication and cognitive behaviour therapy are used in the treatment of schizophrenia. Homoeopathy can also offer promising results in schizophrenia as evident from the previous studies. Case Summary: Five patients reported at the outpatient department of National Homoeopathy Research Institute in Mental Health, Kerala, India, with symptoms of schizophrenia were treated with individualised homoeopathic medicine as an add-on therapy to conventional medicines. Assessment of the patients was done using three scales: Positive and Negative Syndrome Scale, brief psychiatric rating scale and Glasgow Anti-psychotics Side-effects Scale. Possible causal attribution of changes was explicitly depicted by Modified Naranjo Criteria. All five patients showed improvement as evident from the assessment scales. These cases show the positive role of homoeopathic treatment in schizophrenia, reducing the psychotic symptoms and reinstating the insight of the patient and also tapering the conventional medication. To bring out further robust evidence of homoeopathy in schizophrenia, extensive research studies are required.

Results of a Randomized, Double-Blinded Trial of Micronutrients and Fish Oil among Patients Diagnosed with Bipolar Disorder

IntroductionIn a previous open-label study, we found that patients with bipolar disorder improved in symptom level when taking micronutrients and fish oil. We planned a randomized, double-blind, controlled trial to explore the feasibility and parameters needed for a larger clinical trial.ObjectivesWe aimed to determine the parameters necessary to conduct a large-scale clinical trial through completing a feasibility study.MethodsPatients were screened for having the diagnosis of bipolar disorder and being willing to take up to 16 micronutrient capsules and 3 fish oil capsules per day. Patients were randomized in a 3:2 ratio to micronutrients or placebo. Patients were seen monthly with assessment of the Clinical Global Impression Scale, the UKU Side Effects Scale, and a review of their medication doses. On a quarterly basis, patients completed the BASIS-24, the MYMOP-2, the Young Mania Scale, and the MADRS questionnaireResultsThe setting was a primary care clinic in Maine in the United States. The patient population was low-income and primarily rural. Disease severity was mild to moderate as only 2 patients were hospitalized during the study. All were symptomatic. One hundred twenty-five patients were screened and accepted randomization. The attrition rate was high and only 52 subjects completed 6 months of treatment. No differences were found between the two groups. We calculated that a minimum of 250 subjects would be needed to have 80% power to detect a difference. All patients improved dramatically in all measures.ConclusionsBipolar patients in primary care remain moderately symptomatic and will improve dramatically with monthly visits.DisclosureNo significant relationships.

Micronutrients as Adjunctive Treatment for Bipolar Disorder: A Randomized, Double-Blinded, Controlled Trial

ObjectivesAn open label trial had suggested that a comprehensive micronutrient supplement, Empower Plus Advanced, in combination with Fish Oil, would be helpful in reducing symptom burden in adults diagnosed with bipolar disorder.MethodsWe designed a double-blinded, randomized, controlled feasibility trial to explore the parameters necessary to mount a large-scale clinical trial. We aimed to enroll 97 participants and randomize in a 3:2 ratio to Vitamins or Placebo. We recruited patients from a family medicine residency clinic in Maine who were diagnosed in the electronic health record as having bipolar disorder. Diagnoses were confirmed via psychiatric interview or chart review (for obvious cases). The primary outcome measures were changes on the clinical global impressions scale (CGI), changes on the UKU Side Effects Scale, and changes in medications doses.ResultsA total of 69 patients were actually randomized and data were analyzed for 49 patients. The cost per participant was higher than expected due to increased regulatory requirements imposed by our Institutional Review Board (IRB) related to concerns about the hazards of micronutrient supplementation for psychiatric patients. In non-parametric chi-square analysis, significantly more patients in the Vitamin group improved on the CGI over the course of their participation in the study (p = 0.04). However, in parametric analysis the average improvement was not statistically significant between the two groups. All patients showed significant improvement over time in CGI (p = 0.0001) with statistically significant reductions in medication doses and side effects. The only adverse events occurring more among the Intervention group were nausea and loose stools but were not statistically significant.ConclusionsWe suspect the benefits of closer surveillance, medication adjustment (mostly reduction), and human contact overshadowed the potential benefits of micronutrients. Future studies would do well to use a four-month lead-in period during which medications can be adjusted and participants can decide if they are willing to take vitamins for an extended time. Our data suggest that primary care patients with bipolar disorder would fare better on lower medications doses and more frequent visits. Further clinical trials are warranted.Funding SourcesThe Foundation for Excellence in Mental Health.

Improving Medication Adherence in Convalscent Psychiatric Out-Patients Exposed to Psychotomimetic Medications in South-West, Nigeria: The Role of Medication Literacy and `Therapeutic Relationships.

Medication adherence is a growing concern to clinicians and healthcare providers in psychiatric communities, mounting evidence of the prevalence of non-adherence have been significantly associated with undesirable health outcomes and burdensome healthcare expenditure. This study examined medication adherence in psychiatric patients exposed to psychotomimetic medications and how therapeutic relationship predicts the level of medication adherence. This study was a cross-sectional survey design. Snowballing sampling technique was used to select psychiatric out-patients. The total number of participants for this study was thirty-six (36), males (65%) and females (35%). Majority of participants were between the ages of 31-50 years. Participants responded to Morinsky Medication Adherence Scale (α=0.91), Liverpool University Neuroleptic Side-Effect Scale (α= 0.89), and Therapeutic Relationship Scale (patient version) (α=0.71). Three hypotheses were formulated and tested using multiple regression analysis. Results of the multiple regression indicate that psychotomimetic side-effects inversely predicted medication adherence among psychiatric patients exposed to psychotomimetic drugs [β = .35, p &lt;0.01]. Also, the outcome of the results indicated that therapeutic relationship was a significant predictor of medication adherence among psychiatric patients exposed to psychotomimetic drugs [β = .40, p &lt;0.01]. Therefore, it was recommended that therapeutic relationship should be an integral part of the modalities in psychiatric treatment and to adopt best practices by effectively communicating with patients about the importance of adhering to treatment plans; and provide medication support services to patients and family caregivers. This helps to improve, build a sustainable therapeutic relationship (nurse-patient) through empathy and professional intimacy that facilitates diagnosis accuracy, and desired health outcome.

CYP2C19 slow metabolizer phenotype is associated with lower antidepressant efficacy and tolerability

The inter-individual variability in CYP2C19-mediated metabolism may affect the antidepressant treatment. The aim of this study is to evaluate differences in antidepressant efficacy and tolerability between different CYP2C19 metabolizer categories in inpatients suffering from major depressive disorder. The cohort was divided into experimental groups based on CYP2C19 genotype and it contained 24 slow (SMs), 41 normal (NMs), and 37 fast metabolizers (FMs). Efficacy and tolerability were assessed at baseline, and after two and four weeks as a follow-up. The primary efficacy measurement was the change from baseline in Hamilton's Depression Rating Scale (HAMD), while the primary tolerability measurement was the Toronto Side-Effects Scale (TSES) intensity scores at the last visit. The reduction in HAMD score was 36% less pronounced and response rate was exceedingly less prevalent (75% lower) in SMs, compared with NMs. The TSES intensity score was increased in SMs, compared with NMs, by 43% for central nervous system and by 22% for gastrointestinal adverse drug reactions. No significant differences in measured parameters were observed between NMs and FMs. Compared with NM and RM, lower antidepressant efficacy and tolerability was observed in SMs; this association is likely connected with the lower SM capacity to metabolize antidepressant drugs.

Pretreatment anxious depression as a predictor of side effect frequency and severity in escitalopram and aripiprazole adjunctive therapy.

ObjectiveTo report side effect frequency and severity in patients with major depressive disorder (MDD) receiving escitalopram and aripiprazole adjunctive therapy and to examine whether pretreatment anxious depression is associated with the number and presence of specific side effects.Methods188 of the 211 trial participants provided information on side effects during treatment with escitalopram (10–20 mg) for 8 weeks, and nonresponders received further augmentation on aripiprazole (2–10 mg) adjunctive therapy for another 8 weeks, whereas responders remained on escitalopram. Participants completed the Toronto Side Effects Scale at weeks 2, 4, 10, and 12. Covariate‐adjusted negative binomial regression and Wilcoxon tests examined the association between anxious depression (GAD‐7 ≥ 10) and number of side effects. Covariate‐adjusted logistic regression and chi‐square tests explored the association between anxious depression and specific side effects.ResultsFor both therapies, the most frequent side effects were also the most severe. They mostly related to the central nervous system (CNS) (i.e., drowsiness and nervousness). Between baseline and week 2, the number of side effects participants experienced (incidence rate ratio [IRR] = 1.38, p = .010) or had trouble with (IRR = 1.34, p = .026) was significantly higher among those with anxious depression for escitalopram but not adjunctive aripiprazole. Further, odds of experiencing and having trouble with nervousness and agitation were also significantly higher in anxious depression for escitalopram only (p < .05).ConclusionPatients on escitalopram and aripiprazole adjunctive therapy may experience and have trouble with CNS side effects. Pretreatment anxious depression may predispose escitalopram recipients with MDD to developing side effects, especially those related to anxiety.

Clinical validation of the Aarhus Side effect Assessment Questionnaire(ASAQ).

Psychotropic medications are essential in the treatment of mental illness. Unfortunately, these medications are associated with side effects that may reduce adherence to treatment and quality of life. Therefore, systematic screening for side effects is fundamental to optimize treatment with psychotropic medications. Self-report of side effects is a practical alternative to time-consuming clinical assessments. We developed the Aarhus Side effect Assessment Questionnaire (ASAQ) in an attempt to strike the balance between extensive coverage of side effects and reasonable application time. The aim of the study was to validate the ASAQ using the clinician-rated Udvalg for Kliniske Undersøgelser (UKU) Side Effect Scale as gold standard reference. A total of 122 inpatients and outpatients-mainly with psychotic (39%) and affective disorders (43%)-receiving treatment with psychotropic medication completed the ASAQ and the World Health Organization-Five Well-Being Index (WHO-5) and were subsequently rated on the UKU by trained raters. Using the UKU as the gold standard reference, the ASAQ demonstrated sensitivity values >75% for 77% of its 30 items (ranging from 37% for cutaneous disturbances to 98% for increased sweating) and specificity values >75% for 47% of its 30 items (ranging from 28% for reduced sleep to 98% for micturition disturbances). While 17% of the participants considered discontinuing their medication, 24% had recently refrained from taking their medication as prescribed. A negative correlation was found between the ASAQ and the WHO-5 and total scores (Pearson's correlation coefficient = -0.44). The self-reported ASAQ seems to be a sensitive tool for detecting side effects of psychotropic medications.

Clozapine Once-Daily Versus Divided Dosing Regimen: A Cross-sectional Study in Japan.

Clozapine is generally recommended to be prescribed in a divided dosing regimen based on its relatively short plasma half-life. However, there has been little evidence to support the superiority of divided dosing of clozapine over once-daily dosing. To our knowledge, there have been no studies examining differences in actual plasma concentrations or adverse effects between the 2 dosing strategies of clozapine. We aimed to compare actual plasma concentrations of clozapine between once-daily and divided dosing regimens, and to examine the relationships of these regimens with psychiatric symptoms and adverse effects of clozapine. We analyzed data from 108 participants of a previous study conducted in 2 hospitals in Japan. A population pharmacokinetic model was used to estimate the peak and trough plasma concentrations of clozapine based on actual plasma concentrations. We evaluated psychiatric symptoms with the Brief Evaluation of Psychosis Symptom Domains and adverse effects of clozapine with the Glasgow Antipsychotic Side-effects Scale for Clozapine. The estimated peak and trough plasma concentrations of clozapine did not differ significantly between once-daily and divided dosing regimens. There were no significant differences in psychiatric symptoms except for depression/anxiety or subjective adverse effects of clozapine between the 2 dosing strategies. Our findings tentatively support the feasibility and clinical utility of once-daily dosing of clozapine in clinical practice. Further studies are needed to replicate these findings and determine causality between dosing strategies and clinical outcomes.

Cultural Adaptation and Validation of the EORTC QLQ-BR45 to Assess Health-Related Quality of Life of Breast Cancer Patients

Abstract Background The European Organization for Research and Treatment of Cancer (EORTC) QLQ-BR23 is considered a premier module for breast cancer patients that is utilised synchronously with the core questionnaire. However, new and scalable treatments on breast cancer patients’ quality of life (QoL) need a more accurate and comprehensive tool to be assessed. Therefore, the EORTC introduced the newly updated module EORTC QLQ-BR45. Hence, the current study aims to perform cultural adaptation, pilot testing and assessment of the psychometric properties of the Egyptian Arabic translation of the EORTC QLQ-BR45 module on Egyptian breast cancer patients. Patients and Methods First, a review of the existing Arabic translation and the modified preliminary translation was sent to a professional proofreader. Then, comprehensibility of the Egyptian Arabic translation was pilot tested on a sample of 13 breast cancer patients. Afterwards, 74 patients with proven locally advanced breast cancer receiving neoadjuvant chemotherapy at Beni-Suef University Hospital, Beni-Suef, Egypt were interviewed. A second interview was conducted post-surgery for patients receiving target therapy, endocrine therapy or radiotherapy. The psychometric properties of the EORTC QLQ-BR45 were assessed in terms of reliability, convergent and divergent validity. Results Adequate internal consistency reliability (Cronbach’s α coefficients &gt;0.7) was demonstrated for the questionnaire, except for body image scale (α = 0.51) and systemic therapy side effects scale (α = 0.63). Multi-trait scaling analysis exhibited acceptable convergent and divergent validity, and scaling success was observed for all questionnaire items. Conclusion The Egyptian Arabic version of the EORTC QLQ-BR45 module is valid and adequately reliable. These results support using the EORTC QLQ-BR45 in future breast cancer clinical trials.

Curative effect of the combined therapy of warm acupuncture at back-shu points of five zang organs and western medicine on depression of yang deficiency pattern and its attenuating effect

To compare the therapeutic results and the occurrence of adverse reactions of medicine between the combined therapy of warm acupuncture at back-shu points of five zang organs and the western medicine and the simple wes-tern medication, and observe the therapeutic effect and attenuating effect of this combined therapy in treatment on depression of yang deficiency pattern. A total of 80 patients with depression of yang deficiency pattern were randomly divided into an observation group and a control group （39 cases/group）. In the control group, escitalopram oxalate tablets were administered orally every day. In the observation group, on the base of the medication as the control group, warm acupuncture therapy was exerted at back-shu points of five zang organs, for 30 min each time, 5 times a week. The duration of treatment was 6 weeks in two groups. Before and after treatment, the scores of Hamilton depression scale (HAMD) and the antidepressant side effect scale (SERS) were evaluated and electroencephalogram (EEG) was detected; and the curative effect was assessed according to HAMD reduction rate in patients of the two groups. After treatment, the HAMD and SERS scores were lower than those before treatment in both groups. Compared with the control group, the HAMD and SERS scores were lower (P<0.05, P<0.01), and the EEG result was improved (P<0.01) in the observation group. The clinical total effective rate of the observation group was 97.43% (38/39), higher than 92.30% (36/39) of the control group (P<0.05). The combined therapy of warm acupuncture at back-shu points of five zang organs and western medicine effectively relieves depression of yang deficiency pattern in the patients and its overall therapeutic effect is better than simple western medication, besides, the combined therapy alleviates the adverse reactions induced by simple western medication.

The Therapeutic Effect of Edible Horticultural Therapy on Extrapyramidal Symptoms in Patients with Schizophrenia

Extrapyramidal symptoms (EPSs) are common adverse reactions to antipsychotics in patients with schizophrenia. The purpose of this study was to investigate the effects of edible horticultural therapy (EHT) on EPSs in schizophrenic patients. This study assessed the changes in psychopathological symptoms and extrapyramidal symptoms in patients with schizophrenia before and after participating in a six-session EHT. Forty schizophrenic patients, recruited from Wuhan Wudong Hospital, were randomly assigned to the EHT group (average age: 45.40 ± 13.960 years) or the control group (average age: 49.30 ± 12.516 years). The EHT program held weekly sessions from May 2020 to June 2020. A psychiatrist assessed the psychopathological symptoms and extrapyramidal symptoms of schizophrenic patients in both groups with the Chinese version of the Positive and Negative Syndromes Scale (PANSS) and the Rating Scale for Extrapyramidal Side Effects (RSESE). After six courses of horticultural therapy, the terms of positive, negative, and general symptoms on the PANSS significantly improved in the EHT group. Moreover, the EPSs were also significantly improved in the EHT group. However, there was no change in the PANSS and RSESE scores in the control group. This study shows that EHT has the potential to improve not only psychopathological symptoms but also EPSs in psychiatric patients. This adds new evidence for EHT as an adjunct to treatment for schizophrenia.

Monitoring Adverse Effects of Antipsychotics and Antidepressants: A Population Based Study

Abstract: Aim: To monitor the nature and incidences adverse effects of both antipsychotics and antidepressants medicines in the psychiatry outpatient department. Objectives: Reporting the incidences of adverse effects and to establish the frequency of a specific class of drug. Identifying the system affected and the assessment of the management of the adverse effects by the physician. For the study, we have adopted Global Assessment Scale (GAS), Simpson-Angus Extra pyramidal Side Effects Scale (SAS) and The Antidepressant Side-Effect Checklist (ASEC). Materials and Methods: A prospective cohort study carried out in the psychiatry out-patient department. All the patients attending psychiatry outpatient department enrolled based on the pre-specified inclusion criteria and monitored for adverse effects. Causality also assessed by WHO-UMC causality assessment system and Naranjo Causality Assessment. Results: The incidence rate of adverse effects (46.07%) and 560 adverse effects documented. Weight gain (n=29, 9.2%) followed by drowsiness (n=27, 4.82%) are most commonly reported adverse effects. Atypical antipsychotics (n=279, 49.82%) were the most common class of psychotropic drugs implicated in adverse effects. Escitalopram (n=93, 37.80%) followed by olanzapine (n=53, 21.54%) associated with a maximum number of adverse effects. Central nervous system (n=225, 40.17%) was the most affected organ system followed by gastrointestinal system (n=130, 23.21%). Conclusion: Study revealed moderate incidences of adverse effects in patients attending the psychiatry outpatient department. Majority of the adverse effects reported during the study were mild in nature and not preventable. The role of a clinical pharmacist clearly elucidated regular intensive monitoring of adverse effects may improve the quality of patients’ care, reduction in the treatment cost and augmentation of the medication adherence among patients. Key words: Adverse effects, Pharmacovigilance, Antipsychotics, Antidepressants, Extra pyramidal side effects.

Clozapine Management in Schizophrenia Inpatients: A 5-Year Prospective Observational Study of Its Safety and Tolerability Profile.

BackgroundClozapine is well known for its efficacy and clinical superiority compared to other antipsychotics in treatment-resistant schizophrenia (TRS). However, it is frequently underutilized worldwide because of its acute adverse events, as well as for its long-term cardiometabolic and hematological consequences.ObjectiveThe aim of the study was to evaluate 5-year safety in chronic TRS inpatients with continuous clozapine use.MethodsPatients with TRS and clozapine treatment were evaluated for 5 years. All participants were assessed using the Brief Psychiatric Rating Scale (BPRS), Glasgow Antipsychotic Side-effect Scale for Clozapine (GASS-C), Social Performance Scale (PSP) and Short Portable Mental Status Questionnaire (SPMSQ). Clinical, cardiometabolic and hematological data were collected periodically. General linear models (GLM) repeated measures controlling for CLZ dose were utilized to determine differences in variables across the time.ResultsOverall, 189 inpatients were screened for study participation. The final sample included twenty-one TRS patients (16 males, 76%) with an average age of 57.6 years, all with 5-year continuous use of clozapine (mean dose 266 mg/day). There was not a significant effect of time on BPRS (p=0.774), PSP (p=0.855) and SPMSQ (p=0.066); differences remained not significant after controlling for CLZ dose (p=0.585, p=0.467 and p=0.105, respectively). No changes were found in blood and clinical parameters except for red blood cell count, which decreased over time (p=0.024; η2= 0.952). Patients reported a significant BMI decrease (−8.98 kg, p=0.008) between baseline and 5 years last observation.ConclusionThe findings show how the application of a structured dietary, clinical and therapeutic monitoring program in psychiatric care facilities could allow the safe and effective long-term cardiometabolic and hematological management of clozapine. The unique role that clozapine plays in the current treatment of patients with TRS requires greater clinical awareness. Although its acute and chronic side effects are notorious, its safety management is feasible and broadens its potential practical application.

GASS-tly side effects: antipsychotic monitoring for inpatients across NHS Lanarkshire

AimsBest practice in the prescribing of antipsychotic therapy includes monitoring for medication side effects. National guideline SIGN 131 advises the use of a validated side effect scale, for example the Glasgow Antipsychotic Side-effect Scale (GASS). Local recommendation in NHS Lanarkshire advises that patients prescribed antipsychotic therapy should be offered GASS at each contact and after initiation or titration. We aimed to improve compliance with antipsychotic side effect monitoring for inpatients in general adult psychiatry across two hospital sites in NHS Lanarkshire.MethodWe conducted a full-cycle audit. In October 2020, we took a cross-sectional sample of inpatients in general adult psychiatry in University Hospital Hairmyres and University Hospital Wishaw who were prescribed antipsychotic therapy for a functional psychotic disorder. For these inpatients, if applicable, we identified whether GASS had been completed on admission (OA), whether GASS had been completed after initiation or titration of antipsychotic therapy (I/T), and whether GASS had been acknowledged and discussed at consultant-led multi-disciplinary team meeting (MDT). Thereafter, we implemented several targeted interventions in order to improve compliance. In January 2021, we completed the cycle by taking a new cross-sectional sample of inpatients fulfilling identical parameters.ResultFirst cycle in October 2020 (n = 27) showed compliance OA of 4.2%, I/T of 9.5%, and MDT of 3.7%. Our interventions included a presentation at trust-wide clinical governance meeting; a presentation at one of the weekly departmental teaching sessions in psychiatry; an email summarising the audit to consultants in general adult psychiatry; meetings with senior charge nurses for each ward; and inclusion of GASS as part of routine admission paperwork. Re-audit in January 2021 (n = 23) showed compliance OA of 11.1%, I/T of 40.0%, and MDT of 21.7%.ConclusionOur full-cycle audit led to modest improvement in documented monitoring for antipsychotic side effects. There was relatively greater improvement in prescriber-led outcomes I/T and MDT, suggesting increased prescriber awareness. However, rather than reliance on individual prescribers to ensure compliance, consideration of GASS alongside monitoring of other physical health parameters would likely result in greater and more sustained improvement. In NHS Lanarkshire there is ongoing work to this end, ultimately with the intention to set up a defined antipsychotic physical health monitoring schedule, integrated across inpatient and community care.

Improving baseline and follow-up physical health monitoring when commencing oral antipsychotics

AimsNICE guidelines suggest baseline physical health monitoring be performed prior to commencing antipsychotics, in addition to follow-up monitoring for adverse effects for at least 12 months. ‘Shared Care Guidelines’ were adapted from NICE guidance for local use in North East Lincolnshire. Nevertheless, a local audit published in 2018 reported low compliance with baseline monitoring in community mental health teams (CMHTs) compared to inpatient teams. The parameter most infrequently performed overall was the Glasgow Antipsychotic Side Effect Scale (GASS) questionnaire.This study aimed to assess whether compliance with baseline physical health monitoring had improved in line with the previous audit's recommendations. Additionally, it aimed to expand on previous findings by adding compliance data for follow-up physical health checks and produce further recommendations to optimise performance.MethodA retrospective re-audit was performed in NAViGO Health and Social Care to assess compliance with the guidelines for physical health monitoring when commencing antipsychotics in previously antipsychotic-naïve patients. Patient records were examined for which recommended physical health checks were performed at baseline, and at 1-, 3- and 6- months from commencing antipsychotics.Result15 eligible patients were identified to have been commenced on antipsychotics, 8 patients under a CMHT and 7 under an inpatient team. The average overall compliance at baseline for checking 16 parameters was 50%. For the CMHT, compliance was 60%, compared to 38% for the inpatient team. Across both teams, baseline compliance was highest for renal function tests, liver function tests, and blood pressure and pulse (80%). For 1-, 3-, and 6- month checks, overall compliance for checking recommended parameters were 33%, 29% and 29% respectively. GASS monitoring compliance was 7% at baseline, 0% at 1- and 3-months, 7% at 6-months.ConclusionThe CMHT performed better than the inpatient team at baseline monitoring. This may reflect action on the previous audit's recommendations to increase provision of community ‘Wellbeing Health Improvement Service’ (WHISe) clinics. However, performance of the GASS questionnaire at baseline was consistent with the previous audit, with similar performance at follow-up extending these findings.In response, the first recommendation is for Quality Improvement Activities to help improve compliance with the ‘Shared Care Guidelines’. This may include CQUINs and further provision of community clinics to improve compliance with both baseline and follow-up checks. Secondly, it is proposed that GASS questionnaires be sent to patients prior to appointments to be completed in advance to avoid further risk of GASS being incomplete.