Efficacy of Oxcarbazepine for Sleep-Related Leg Cramps: A Retrospective Study

Objectives: Sleep-related leg cramps (SRLC) are common among older people. Severe clinical symptoms of SRLC usually cause great discomfort to patients. To date, many treatment drugs have been tried; however, there are currently no drugs approved for treating this condition. We aimed to assess the efficacy of a new drug, oxcarbazepine (OXC), in the treatment of SRLC.Methods: We retrospectively analyzed clinical outcomes following OXC administration. A daily dose of 150 mg OXC was prescribed to control nocturnal leg cramps. Clinical outcomes were measured using the Clinical Global Impression Scale to confirm the effectiveness of OXC.Results: A total of 88.9% (16/18) of patients clinically improved four weeks after OXC prescription, and 94% (15/16) of patients continued to improve at the last follow-up (3–6 months). None of the patients complained of side effects related to 150 mg OXC.Conclusions: OXC may be a new medical option for treatment of SRLC.

Vortioxetine for depression treatment in hospital setting: experience from a single psychiatric hospital

The study was conducted to assess the possibility of using vortioxetine for the treatment of depressive disorders in a hospital setting. Material and methods: 32 patients with depressive disorders of various etiologies were included. Patients were assessed using Clinical Global Impression scale and Hamilton Depression Rating Scale HDRS-17 at the beginning of the study and in dynamics. Mean HDRS-17 value at the beginning was 20.1±6.6. According to the etiology of depressive disorders patients were divided into three groups: endogenous disorders—17, organic depressions—11, reactive states—4. Patients were followed-up for 60 days. Results. Vortioxetine was used both as first line treatment and after previous therapy, 10 to 20 mg a day. In 7 patients (21,9%) therapy was discontinued due to adverse events or worsening of condition. The remaining 25 patients (78,1%) showed positive dynamics. Patients with depression with psychotic features (n = 18) were assessed separately: in 5 patients therapy was discontinued, in the remaining 13 people positive dynamics were noted. Conclusion. The study has demonstrated high efficacy of vortioxetine when prescribed for the treatment of depressive disorders, including psychotic depression, in a hospital setting. The drug was well tolerated in the majority of patients.

S246. THE EFFECT OF INCORRECT SCALE ADMINISTRATION ON DATA QUALITY IN SCHIZOPHRENIA CLINICAL TRIALS

Background The availability of date and time stamps of interview start times on eCOA systems permits monitoring and documentation of the order of administration of scales and instruments at each visit. The Clinical Global Impression Scale (CGI) is a holistic instrument that synthesizes all information available from the subject, caregivers, medical notes, etc. and is therefore typically required to be rated last at a particular visit. In the current retrospective analysis of double blind eCOA collected schizophrenia data pooled from multiple clinical trials we assessed the percent of visits where CGI was not administered last among other efficacy assessments. Additionally we assessed whether the inappropriate administration order of Clinical Global Impression Scale was associated with discrepancies in the data and change from baseline between the CGI and the primary efficacy outcome. Methods Available eCOA data were pooled from schizophrenia double blind, placebo controlled clinical trials. Within the data, we identified those visits where the CGI was not administered last among other efficacy assessments (inappropriate administration order). Within each trial we identified as discordant those data where the actual primary efficacy score or its change from baseline differed by at least two standard deviations from the expected score after linear regression. For this procedure the CGI- S score used as a predictor and the primary efficacy outcome as dependent variable. Logistic regression was then used on pooled data to explore whether the incorrect order of CGI administration increased the odds of discordant ratings between the CGI and primary outcome measure. Results The dataset consisted of 5,784 paired ratings of the CGI and the primary efficacy outcome. Among these, a total of 4,628 visits allowed to calculate change from baseline. Inappropriate order of CGI administration was identified in a total of 443 visits (7.7% of all visits). Discrepancies between CGI-S and the primary efficacy outcome were identified in 292 visits (5.1% of data) and discrepancies between change from baseline in CGI-S and in the primary efficacy outcome were observed in 249 cases (5.3% of data). The presence of incorrectly administered CGI increased the odds of raw score discrepancy 1.6x (95%CI 1.1–2.4), and the odds of discrepancy in change from baseline 1.8x (95%CI 1.2–2.7), both significant with p <0.01. Discussion Our data indicate a relatively large percent of visits suffer from an incorrect scale administration order. We have previously explored a number of sources of possible noise in schizophrenia clinical trials. Current analyses identified a significant effect of incorrect scale administration on the presence of between scale discordances. Such findings indicate that order of CGI administration should be mandated in schizophrenia clinical trials and enforced by eCOA platforms. Additionally, violations to correct scale administration should be monitored through analytic programs and acted upon in case of repeated occurrences at the rater or site level.

Tolerability and side effects of an extended-release injectable suspension of aripripazole in a series of inpatients in a dual diagnosis unit

IntroductionThe integrated care in dual diagnosis units involves selecting pharmacological treatment strategies for both substance use disorder and the non-addictive psychiatric disorder. It is recommended to choose drugs with a favorable balance between efficacy/tolerability, an adequate side effects profile and the minimal drug interactions.Objectives and aimsTo evaluate the tolerability and side effects after first administration-first dose of an extended-release injectable suspension of aripiprazole in a group of patients admitted to an acute dual diagnosis unit.MethodsThe study included a series of patients admitted in our unit from May to August 2015 that received the first dose of the aripiprazole preparation (400 mg). Evaluations included different scales for side effects (SAS, ESRS, UKU) and the clinical global impression scale (CGI).ResultsA total of 9 patients were included and evaluated (all men, mean age: 39-years-old). Diagnoses were: bipolar disorder (5/9), schizophrenia (2/9), schizoaffective disorder (1/9) and delusional disorder (1/9) with concomitant substance use disorder (6 cannabis, 2 alcohol, 1 cocaine). All of them without outpatient control and treatment at admission. The results of the clinical scales conclude that none of them had significant side effects, including extrapyramidal, with an improvement in the ICG scale.ConclusionTolerability of extended-release injectable suspension of aripiprazole was good in all cases. In the future, new cases should be included to extend the sample and to evaluate other aspects such as the craving for substances.Disclosure of interestThe authors have not supplied their declaration of competing interest.

High Familial Correlation in Methylphenidate Response and Side Effect Profile

Objective: To examine whether a familial tendency exists in clinical response to methylphenidate. Method: Nineteen pairs of siblings or parent–child stimulant-naive individuals with ADHD were prescribed methylphenidate–immediate release, and were comprehensively evaluated at baseline, Week 2, and Week 4, using the ADHD Rating Scale IV, Clinical Global Impression Scale, and the Barkley Side Effects Rating Scale. Results: We found significant intraclass correlations in family member response to methylphenidate–immediate release and side effect profile, including emotional symptoms and loss of appetite and weight. Conclusion: Family history of response to methylphenidate should be taken into account when treating ADHD.