COGNITIVE REMEDIATION AND PHYSICAL EXERCISE EFFECTS ON NEGATIVE SYMPTOMS AND FUNCTIONALITY IN PATIENTS WITH SCHIZOPHRENIA: A RANDOMIZED CONTROLLED TRIAL

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SIRS 2020 Abstracts

S150 Poster Session II

to the Strong response group, while olanzapine strongly predicted the belonging to the Slight response group. There was no signifi- cant difference among the antipsychotic drugs regarding the Good response group. Discussion: Most patients (74%) with a schizophrenia spectrum diagnosis showed a good response during the one year follow-up and another 13% showed a remarkable strong improvement. That means that a total of 87% of patients had a satisfactory course of illness during the first year. Use of amisulpride predicts a better course compared to aripiprazole and olanzapine. This finding can be useful for clinicians when selecting antipsy- chotic drugs for their patients.

M42. INDEPENDENT REVIEW & MONITORING IMPROVES QUALITY OF PANSS DATA IN GLOBAL CLINICAL TRIALS

Barbara Echevarria*1, Cong Liu1, Selam Negash1, Mark Opler1, Patricio Molero2, Gianna Capodilupo1 1WCG MedAvante-ProPhase; 2Clinica Universidad de Navarra, Spain

Background: The Positive and Negative Syndrome Scale (PANSS) (1) is the most widely used endpoint for measuring change in schizophrenia clin- ical trials. A set of flags have been developed by ISCTM expert working group to identify potential scoring errors in PANSS assessments (2). Measures have been taken by sponsors (pharmaceutical industry) with the goal of increasing scoring reliability and data quality, such as the use of Independent Review (IRev). We evaluated changes in data quality when site raters stop being recorded and monitored via IRev by comparing two studies with the same cohort of raters, one with independent review and one without. Methods: Data from PANSS assessments in two global multisite schiz- ophrenia clinical trials were analyzed. We selected data from raters participating in both studies (which run concurrently for a signifi- cant period of time). Raters were rigorously trained on administra- tion and scoring conventions and certified prior to the study through demonstration of adequate interrater reliability. In addition to these steps, raters in study A were required to audio record all PANSS assessments with a selected subset of visits being subject to IRev. PANSS assessments in study B were neither recorded nor monitored via IRev. Data quality after study completion was examined by calcu- lating the frequency of anomalous data patterns identified as “high” (very probable or definite error) by the ISCTM Working Group in both studies. Additionally, we examined the percentage of assessments with lower than expected PANSS interview duration as captured via an eCOA platform. Results: There were 9441 eCOA PANSS assessments in study A and 6178 in study B included in this analysis. The proportions of flags that represented highly probable/definite error differed significantly between the studies (9% vs 18% for Study A and B, respectively, p<.01). The most significant differences in ISCTM flags were related to overly con- sistent scoring patterns (27 or more items scored identically to the prior visit) occurring with higher frequency in study B. Additionally, study B also had a significantly higher frequency of assessments flagged for low interview duration (< 15 minutes) (1% vs 4% for Study A and B, respec- tively, p<.01). Discussion: Initial rater training is necessary but not sufficient to en- sure adequate data quality in schizophrenia trials. Implementation of additional in-study oversight through Independent Review or similar methods reduces the probability of data error in PANSS assessments, including the appearance of improbable rating patterns and decreased time spent interviewing study subjects. One potential limitation is that study A is a double-blind study whereas study B is an open label exten- sion of study A.

M43. MODEL-BASED ANALYSIS OF EFFECTS OF LURASIDONE ON PROLACTIN IN SCHIZOPHRENIA PATIENTS Abstract not included.

M44. COGNITIVE REMEDIATION AND PHYSICAL EXERCISE EFFECTS ON NEGATIVE SYMPTOMS AND FUNCTIONALITY IN PATIENTS WITH SCHIZOPHRENIA: A RANDOMIZED CONTROLLED TRIAL

Anna Mane*1, Romina Cortizo2, Adelina Abellanas3, Elena Belmonte3, Alba Toll4, Jacobo Chamorro3, Devi Treen5, Lourdes Ayllon3, Javier Polo3, Teresa Salvador3, Daniel Moreno3, Ferran Catala3, Patricia Casado3, Dolors Navas3, Nuria Pujol6 1Institut de Neuropsiquiatria i Addiccions, Parc de Salut Mar, Barcelona, Hospital del Mar Medical Research Institute (IMIM), Centro de Investigación en Red de Salud Mental (CIBERSAM); 2Parc Sanitari Sant Joan de Deu; 3Institut de Neuropsiquiatria i Addiccions, Parc de Salut Mar, Barcelona; 4Hospital del Mar Medical Research Insitute (IMIM); 5Germanes Hospitalaries Sagrat Cor; 6Institut de Neuropsiquiatria i Addiccions, Parc de Salut Mar, Barcelona, Hospital del Mar Medical Research Insitute (IMIM)

Background: Cognitive and negative symptoms are key determinants in schizophrenia functionality. Cognitive remediation (CR) has shown to improve cognition in patients with schizophrenia but the impact on func- tionality is still unsatisfactory. On the other hand, an improvement in neg- ative symptoms has also been described with CR and some studies have shown physical exercise (PE) may also improve negative symptoms. The present study sets out to investigate the effects of CR+PE in overall nega- tive symptoms, and more specifically, in the avolition and expression factor, as well as in functionality, in a sample of patients diagnosed with multi- episode schizophrenia. Furthermore, it sets out to investigate determinants of functionality at follow-up. Methods: Randomized controlled trial with two groups: CR+PE and CR plus lifestyle promotion (LP) (control group) (www.clinicaltrials.gov, NCT 02864576). Participants: Subjects fulfilling DSM-IV-TR criteria for schiz- ophrenia or schizo-affective disorder diagnosis, aged between 25–60 years, with an illness duration >o = 10 years, clinically stable and with low physical activity were included. Each randomly assigned intervention consists of 36 sessions carried out 3-times/week in groups of 4–6 participants of CR+PE or CR+LP. Analyses: Baseline sociodemographic and clinical characteris- tics were assessed at baseline in both groups. Repeated measures of multiple analysis of variance (MANOVA) was performed for negative symptoms (BNSS total scale and avolition and expression factors) and functionality (GAF score) with group (CR+PE vs CR+LP) as the between-subject factor and time (pre-treatment and post-treatment) as the within-group factor. The main effects of time, group, and time × group were examined. Multiple regression analysis (whole sample) with GAF at follow-up as the dependent variable and avolition, expression and PANSS-P subscale at follow-up, and gender and age as independent variables was also carried out. Results: 43 patients were included and randomized. 38 patients completed the study, 19 in each group. There were not statistically significant differences between both groups at baseline. There was a time x grup effect on GAF at follow-up (F=4.25 p= 0.047) and on the avolition factor (F=2.99 p= 0.09), with improvements in favour of the CR+ PE group. Furthermore, GAF at follow-up was only related with the avolition factor in the multiple regres- sion analysis (B= -0.63, t -2.84, p=0.009 (CI -1.09-0.17)). Discussion: CR+PE is associated with an improvement in negative symptoms, and more specifically, in the avolition factor, as well as in func- tionality. This specific improvement in the avolition factor is important, as

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SIRS 2020 Abstracts

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functionality at follow-up is specifically associated with the avolition factor in our study, in accordance with previous studies. This work is funded by the Instituto de Salud Carlos III-Subdirección General de Evaluación y Fomento de la Investigación, with the Research Project PI15/00453.

M45. EFFICACY AND SAFETY OF THE ASENAPINE TRANSDERMAL PATCH, HP-3070 (SECUADO©), FOR SCHIZOPHRENIA: A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, INPATIENT STUDY Abstract not included.

M46. THE STUDY OF HEART RATE VARIABILITY AND EMOTIONAL RESPONSE TO POSITIVE AND NEGATIVE AUDIOVISUAL STIMULATION IN PATIENTS WITH SCHIZOPHRENIA

Seung-Ho Jang*1, Won-Myong Bahk2, Young-Joon Kwon3, Bo-Hyun Yoon4, Kwanghun Lee5, Moon-Doo Kim6, Beomwoo Nam7, Sang-Yeol Lee8 1Wonkwang University Hospital; 2Yeouido St. Mary’s Hospital, The Catholic University of Korea; 3Soonchunhyang University Cheonan Hospital; 4National Hospital; 5College of Medicine, Dongguk University; 6Jeju National University; 7School of Medicine, Konkuk University; 8Wonkwang University Hospital

Background: This study was to investigate the Heart Rate Variability (HRV) and emotional response to positive and negative audiovisual stimulation in patients with chronic schizophrenia and healthy control group. Methods: Among 253 chronic schizophrenic patients, 104 patients were in- formed about this research and consented. 35 healthy control consisted of peoples that did not have past and present history of mental and physical ill- ness. Positive and negative affect and HRV were compared between chronic schizophrenia and healthy control groups, and positive and negative affect and HRV to positive and negative audiovisual stimulation were measured. Positive and negative audiovisual stimulation was defined by an art therapy professionalist and a psychiatrist as 10 positive and negative pictures. 3 positive and negative musics were shown to two groups for 4 minutes simulta¬neously. Positive and negative audiovisual stimulation were shown to two groups during 1-week intermission. HRV was measured with Ubpulse H3, an equipment for autonomic nervous system test made by Laxtha com- pany and also analyzed by frequency domain analysis. Emotional Empathy Scale(EES) and Positive Affect and Negative Affect Schedule (PANAS) of two groups were measured at baseline and after positive and negative au- diovisual stimulation. Global Assessment of Functioning Scale(GAF) and Positive and Negative Syndrome Scale(PANSS) of chronic schizophrenia group were measured by a psychiatrist. Results: Positive affect of patients group were significantly lower than con- trol group, negative affect of patients group were significantly higher than control group. Low Frequency (LF), High Frequency (HF), and Total Power (TP) of HRV in patients group were significantly lowered than con- trol group at baseline. 7 subscales of emotional empathy scale were lowered in patients group compared to control group. Positive affect of patients group was significantly less increased compared to the control group after positive audiovisual stimulation, negative affect of patients group was significantly less decreased to the control group after positive audi- ovisual stimulation. Positive affect of patients group was increased after negative audiovisual stimulation, but positive affect of control group was significantly decreased compared to the patients group after negative audi- ovisual stimulation. There was no significant difference in negative affect between two groups after audiovisual stimulation. LF of patients group

was significantly higher than control group after positive audiovisual stimu- lation, HF and TP of patients group were significantly lowered than control group after positive audiovisual stimulation. LF of patients group was sig- nificantly higher than control group after negative audiovisual stimulation, HF and PT of patients were significantly lowered than control group after negative audiovisual stimulation. Discussion: Audiovisual stimulation in integrative arts therapy program for schizophrenia might have avoid overactive sympathetic stimulation and rec- ommend activate parasympathetic stimulation. Integrative art therapy for schizophrenia must be sufficiently relaxed, empathetic, and promote posi- tive affect during therapeutic process.

M47. AKATHISIA AND ATYPICAL ANTIPSYCHOTICS: EXPLORING ASSOCIATIONS TO SUICIDALITY AND AGITATION

Jill Bjarke*1, Helga Nødland Gjerde2, Else-Marie Løberg3, Hugo A Jørgensen4, Rune A. Kroken5, Erik Johnsen6 1Haukeland University Hospital; NORMENT Center of Excellence, University of Oslo; 2University of Bergen; 3Haukeland University Hospital; NORMENT Center of Excellence, University of Oslo;; 4Faculty of Medicine and Dentistry, University of Bergen; 5Haukeland University Hospital; NORMENT Center of Excellence, University of Oslo; University of Bergen; 6Haukeland University Hospital; NORMENT Center of Excellence, University of Oslo; University of Bergen

Background: Antipsychotic associated akathisia is a highly relevant clinical phenomenon. The common side effect can be stigmatizing, cause subjective distress and depression, lead to medication noncompliance and be poten- tially disabling for patients with psychosis. Associations between akathisia and both suicide, depression and agitation has been suggested in research literature, but inconsistently. This study investigates the level of akathisia at hospital discharge/first follow-up for consecutively admitted patients with acute phase psychosis, comparing four atypical antipsychotics (AAPs) re- garding the presence of akathisia, and explores possible associations be- tween akathisia and both suicidality, depression and agitation. Methods: This study is a sub-study of the Bergen Psychosis Project (BPP), a pragmatic, rater-blind, randomized trial comparing head-to-head ziprasidone, olanzapine, risperidone and quetiapine. The present study reports cross-sectional data at discharge/first follow-up after acute admis- sion to hospital for patients with psychosis. Patients were assessed with The Positive And Negative Syndrome Scale (PANSS). We applied the validated PANSS Excited Component (PANSS-EC) factor to assess agitation. The PANSS-EC consists of the five PANSS items: P4 Excitement, P7 Hostility, G4 Tension, G8 Uncooperativeness and G14 Poor impulse control. To assess de- pression in general and suicidality specifically we used the validated Calgary Depression Scale for Schizophrenia (CDSS).Furthermore the Clinical Global Impression – Severity Scale (CGI-S), and the patient-administered version of the UKU Side Effect Self-Rating Scale (UKU SERS Pat). Results: A total of 109 patients were included of which 35 (32.1 %) were females, mean age was 34.0 (12.4). The mean total PANSS score was 54.9 (14.4), the mean CGI-S was 3.7 (1.1) and the mean total CDSS score was 3.9 (4.0). Our preliminary results show that a total of 58 (53.3%) patients had used antipsychotics before entering the study. Some level of akathisia was reported by ¼ of the patients, meaning a score of 1 or more on the UKU SERS Pat. There was a statistically significant difference between ziprasidone and olanzapine, with higher akathisia level in the ziprasidone group. Furthermore, there were statistically significant correlations between akathisia and suicidality and between akathisia and depression. We found no significant correlation between akathisia and the PANSS-EC factor or between akathisia and the PANSS general item G14 Poor impulse control. Statistical details will be presented on the poster.