Positive And Negative Symptom Scale Total Score Research Articles

Correlation of Serum High-Sensitivity C-Reactive Protein, Homocysteine, and Macrophage Migration Inhibitory Factor Levels With Symptom Severity and Cognitive Function in Patients With Schizophrenia.

This trial analyzed high-sensitivity C-reactive protein (hs-CRP), homocysteine (Hcy), and macrophage migration inhibitory factor (MIF) level in serum and their correlation with symptom severity and cognitive function in patients with schizophrenia (SP). Sixty-eight SP patients were enrolled in the SP group, and 68 healthy volunteers were in the control (CN) group. Serum hs-CRP, Hcy, and MIF were measured, and symptom severity was assessed with the Positive and Negative Symptom Scale (PANSS). Cognitive function was determined with the MATRICS Consensus Cognitive Battery (MCCB). The SP group was divided into high PANSS score (PANSS ≥70 points) and low PANSS score (PANSS <70 points), or the mild cognitive dysfunction group and severe cognitive dysfunction group according to the median MCCB score. The correlation between serum hs-CRP, Hcy, and MIF levels and PANSS and MCCB scores in SP patients was examined by Pearson correlation analysis. SP patients had higher serum hs-CRP, Hcy, and MIF levels and showed higher PANSS scores and lower MCCB total score. Serum hs-CRP, Hcy, and MIF levels in the high PANSS group were higher than those in the low PANSS group and in the severe cognitive dysfunction group than in the mild cognitive dysfunction group. Serum hs-CRP, Hcy, and MIF levels in SP patients were positively correlated with PANSS total score and negatively correlated with MCCB total score. High serum hs-CRP, Hcy, and MIF levels in SP patients are correlated with symptom severity and cognitive dysfunction.

Multigenetic Pharmacogenomics–Guided Treatment vs Treatment As Usual Among Hospitalized Men With Schizophrenia

Limited evidence supports multigenetic pharmacogenomics-guided treatment (MPGT) in schizophrenia. To evaluate the clinical effectiveness of MPGT in schizophrenia in a randomized clinical trial (RCT). This RCT was conducted from March 2020 to March 2022. Male Chinese Han inpatients aged 18 to 60 years diagnosed with schizophrenia with a Positive and Negative Symptom Scale (PANSS) score of 60 or more from 2 selected study hospitals were included. Patients and raters were masked to MPGT or treatment as usual (TAU) randomization. Participants were randomly assigned in a 1:1 ratio to receive either MPGT or TAU for 12 weeks. The primary efficacy outcome was the percentage change in PANSS total scores (range, 30 to 210) from baseline to week 6 analyzed by a modified intention-to-treat mixed model for repeated measures. The secondary outcome included response and symptomatic remission rates. A total of 210 participants (mean [SD] age, 29.2 [8.8] years) were enrolled and analyzed, with 113 assigned to MPGT and 97 to TAU. Compared with those randomized to TAU, participants randomized to MPGT demonstrated a significantly higher percentage change in PANSS score (74.2% vs 64.9%; adjusted mean difference, 9.2 percentage points; 95% CI, 4.4-14.1 percentage points; P < .001) and a higher response rate (93 of 113 [82.3%] vs 63 of 97 [64.9%]; adjusted odds ratio, 2.48; 95% CI, 1.28-4.80; P = .01) at the end of week 6. In this RCT of MPGT, MPGT was more effective than TAU in treating patients with schizophrenia. These findings suggest that multigenetic pharmacogenomic testing could serve as an effective tool to guide the treatment of schizophrenia. Chinese Clinical Trial Registry Identifier: ChiCTR2000029671.

Association of serum brain-derived neurotrophic factor level and early response to antipsychotic drug in first-episode patients with schizophrenia.

To investigate the role of Brain derived neurotrophic factor (BDNF) in the psychotic symptoms in first-episode patients with schizophrenia and whether BDNF levels were associated with the improvement of psychotic symptoms after risperidone treatment. 89 schizophrenia patients and 90 healthy controls were recruited, the schizophrenia patients were assigned into early response or early non-response groups at 2weeks based on improvement in the positive and negative symptoms scale (PANSS) total score. All patients were treated with risperidone for 2weeks, their serum BDNF levels were compared at baseline and after 2weeks treatment. We found that patients had lower BDNF levels, compared to controls at baseline. After 2weeks of treatment of risperidone, BDNF levels were significantly increased and psychotic symptoms were decreased in early response group. Correlation analysis showed that the change of BDNF levels after treatment was correlated with the change of PANSS total score. Further regression analysis showed that the change in BDNF levels was an independent predictor for the improvement in psychotic symptoms. Our findings reveal that the level of BDNF was lower in first-episode schizophrenic patients, moreover, the changes in serum BDNF levels may have a predictive effect on the early improvement in psychotic symptoms in the first 2weeks.

Effect of transdermal drug delivery therapy on anxiety symptoms in schizophrenic patients.

To evaluate the efficacy and safety of transdermal drug delivery therapy for schizophrenia with anxiety symptoms. A total of 80 schizophrenic patients (34 males and 56 females) with comorbid anxiety disorders were randomly assigned to the treatment group (n = 40) and the control group (n = 40) with 6 weeks of follow-up. The patients in the treatment group received the standard antipsychotic drug treatment along with transdermal drug delivery therapy. The evaluation of the patients included the Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale (HAMD-17), and treatment emergent symptom scale (TESS) at baseline, 3 weeks, and 6 weeks after transdermal drug delivery therapy. The Positive and Negative Symptom Scale (PANSS) was assessed at baseline and after 6 weeks of treatment. After 3 and 6 weeks of treatment, the HAMA scale scores in the treatment group were lower than those in the control group (p < 0.001). However, there were no significant differences in the HAMD-17 scale scores, PANSS total scores, and subscale scores between the two groups (p > 0.05). Additionally, no significant differences in adverse effects were observed between the two groups during the intervention period (p > 0.05). After 6 weeks of penetration therapy, there was a low negative correlation between total disease duration and the change in HAMA scale score (pretreatment-posttreatment) in the treatment group. Combined traditional Chinese medicine directed penetration therapy can improve the anxiety symptoms of patients with schizophrenia and has a safe profile.

A study of post-traumatic stress disorder in schizophrenic patients 35 years after experiencing the Tangshan earthquake.

This study aimed to investigate the relationship between dissociative experiences, post-traumatic stress disorder (PTSD), and psychiatric symptoms exhibited byschizophrenic patients 35 years after the Tangshan earthquake. Seventy-one schizophrenic patients who had experienced the Tangshan earthquake were selected and evaluated by the Post-traumatic DissociativeExperience Questionnaire (PDEQ), thPTSD Checklist-Civilian Version (PCL-C), and the Positive and Negative Symptom Scale (PANSS). The score of Group B (re-experiencing symptoms) in PCL-C was significantly positively correlated with age and significantly negatively correlated with the course of schizophrenia. Both gender and marriage were significantly positively correlated with the score of PCL-C Group D (irritability symptoms caused by hyperarousal). The PDEQ score was negatively correlated with thecourse of schizophrenia and positively correlated with the presence of sleep difficulties. Significant differences were foundbetween the PCL-C scores of the positive and negative symptoms of the three core symptom groups; the positive rate of Group B was significantly higher than that of Group D, and the positive rate of Group C was significantly higher than that of Group D. The PCL-C total score was positively correlated with the negative symptom factor score of PANSS; Group C's symptoms were significantly negativelycorrelated with the positive factor score of PNASS; andGroup D's' symptoms were significantly negatively correlated with the PANSS total score and thepositive factor score. When consiering patients with schizophrenia post the Tangshan earthquake, age, gender, and marital status were all positively correlated with PTSD. The course of schizophrenia was negatively associated with PTSD and dissociative experiences. PTSD was positively correlated with the negative symptoms of schizophrenia and negatively correlated with the positive symptoms of schizophrenia. Thus, the conditions and symptoms of PTSD may interact with those of schizophrenia.

Leptin Methylation and mRNA Expression Associated With Psychopathology in Schizophrenia Inpatients

Leptin involved in the regulation of dopaminergic neurons of the central nervous system may confirm the hypothesis of neurodevelopment in schizophrenic patients. However, specific genetic mechanisms are undefined. Therefore, we aimed to explore the regulation of DNA methylation of leptin promoters and mRNA expression in patients with schizophrenia. A cross-sectional study enrolled 40 patients and 40 healthy controls from the Beijing Huilongguan Hospital in China. The leptin methylation levels and mRNA expression were examined by highly sensitive mass spectrometry based on the MassARRAY System and real-time quantitative polymerase chain reaction (qPCR). The Positive and Negative Symptoms Scale (PANSS) was applied to estimate the clinical symptoms of patients. The LEP-CpG7 and CpG15 methylation in patients were significantly higher than in healthy controls (P < 0.05). The LEP-CpG11, CpG33.34.35, CpG36 methylation, and mRNA expression decreased significantly in patients compared with healthy controls (P < 0.05). After controlling gender, age, BMI, dose of antipsychotic and duration of illness, LEP-CpG7 methylation was negatively associated with PANSS positive symptoms subscore (r = −0.485, P = 0.005). In addition, LEP-mRNA expression was negatively correlated with PANSS total score (r = −0.385, P = 0.03) and positive subscale (r = −0.392, P = 0.026). Nevertheless, only the LEP-CpG7 methylation level remained negatively correlated to the PANSS positive subscore following multiple stepwise regression (β = −17.071, P = 0.037). These results suggest that leptin methylation and mRNA expression might contribute to the pathogenesis of schizophrenia. LEP-CpG7 methylation may be negatively associated with positive symptoms in patients with schizophrenia.

Gender Differences of Schizophrenia Patients With and Without Depressive Symptoms in Clinical Characteristics.

Objectives: To investigate the differences in psychotic symptoms and cognitive function in schizophrenics with and without depression and to compare gender differences in the correlation between depressive symptoms and clinical characteristics in those patients.Methods: A total of 190 schizophrenia patients and 200 healthy controls were recruited in the study. We used the Positive and Negative Symptom Scale (PANSS), the Calgary Depression Scale for Schizophrenia (CDSS) and the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) to evaluate the psychiatric symptoms, depressive symptoms and cognitive function, respectively. Patients with CDSS score ≥7 were divided into depression group, and CDSS < 7 was viewed as without depression.Results: Patients with schizophrenia had lower total scores of RBANS and five subscale (immediate memory, visual span, verbal function, attention, and delayed memory) scores compared to healthy controls. In the case group, patients who concomitant with depression had higher PANSS scores (Ps < 0.001) and lower RBANS (Ps < 0.05) scores than those without depression. After gender stratification, PANSS total scores and subscale scores were significantly different between schizophrenics with and without depressive symptoms in both male and female groups (Ps < 0.001). For cognitive function, there were significant differences in RBANS total score and subscale scores except attention between female patients with and without schizophrenia but not in male schizophrenia patients. Furthermore, the correlation analysis showed that the total CDSS score was positively correlated with PANSS score (P < 0.001) and RBANS score in male and female groups (male: P = 0.010, female: P = 0.001).Conclusion: Our findings provided evidence supporting the gender differences in psychiatric symptoms and cognitive function between schizophrenia patients with and without depressive symptoms.

Short-term Efficacy and Safety of Lurasidone Versus Placebo in Antipsychotic-Naïve vs. Previously Treated Adolescents with an Acute Exacerbation of Schizophrenia.

AbstractBackgroundTo evaluate the efficacy of short-term lurasidone in antipsychotic treatment-naïve (TN) adolescents with schizophrenia versus those treated previously (TP) with antipsychotics.MethodsPatients aged 13–17 with schizophrenia, and a Positive and Negative Symptom Scale (PANSS) score ≥ 70 and &lt; 120, were randomized to 6 weeks of double-blind treatment with lurasidone (40 or 80 mg/day) or placebo. In a post-hoc, pooled-dose analysis, efficacy was evaluated for TN (criteria: never received antipsychotic treatment) versus TP at the time of the study. Treatment response criteria: ≥20% reduction in PANSS total score.ResultsAltogether, 57 TN and 269 TP patients enrolled in the 6-week DB study. Mean endpoint change in PANSS total score was significantly greater for lurasidone versus placebo in both the TN group (−25.0 vs. -14.4; p &lt; 0.02; effect size = 0.75), and in the TP group (−17.3 vs. -10.0; p &lt; 0.001; effect size = 0.45); and responder rates were higher for lurasidone versus placebo in both the TN group 84.6% versus 38.9%; number needed to treat [NNT] = 3 and in the TP group (60% vs. 42%; NNT = 6). Rates of treatment-emergent adverse events, and mean changes in body weight and metabolic parameters were similar for the TN and TP groups.ConclusionsIn a 6-week, placebo-controlled trial, lurasidone demonstrated significant efficacy in adolescents with schizophrenia regardless of previous antipsychotic therapy status; however, the effect size was notably larger in the TN patient group. In both the TN and TP groups, minimal effects were noted on weight, metabolic parameters, or prolactin.

Investigating Predictors of Clozapine Response in Adolescents with Schizophrenia and Schizoaffective Disorder.

Objectives: We aimed to determine the clinical predictors of clozapine response in patients with early-onset schizophrenia (EOS)/schizoaffective disorder and the effect of substance use disorder (SUD) on treatment outcomes. Methods: Medical records of patients with treatment-resistant EOS receiving clozapine were identified for data analysis dated between January 2015 and April 2020. Patients on clozapine were followed in an inpatient unit of a tertiary care mental health hospital. Using the Positive and Negative Symptom Scale (PANSS), ≥30% reduction was defined as the response criteria after clozapine treatment. Results: Of 50 subjects (age: 16.3 ± 1.3 years, 36.0% female), 22 subjects (44.0%) met the defined response criteria. Clozapine responder (CLZ-R) and clozapine nonresponder (CLZ-NR) groups were similar regarding age at illness onset, sex, and duration of untreated psychosis. The CLZ-R group had higher baseline positive PANSS scores (24.8 ± 8.1 vs. 17.1 ± 6.6, p = 0.001, d = 1.0) and total PANSS scores (94.8 ± 17.2 vs. 80.1 ± 19.8, p = 0.008, d = 0.8) compared with the CLZ-NR counterparts. The duration of hospital stay was longer in the CLZ-NR group (122.3 ± 48.2 vs. 87.3 ± 36.2 days, p = 0.007). Among 32 male patients, the presence of SUD (n = 9, 28.1%) was associated with a less reduction in total PANSS scores (F = 7.5, p = 0.010) and higher levels of positive symptoms at the end of the treatment (12.8 ± 4.1 vs. 18.8 ± 7.4, p = 0.006, d = 1.0). Synthetic cannabinoids were the most common substance type used among males with treatment-refractory EOS (25.0%). Conclusions: Our results did not support the role of sociodemographic variables in clozapine response. Positive symptoms and SUD yielded a prognostic value in patients receiving clozapine.

Gender Differences in the First-Year Antipsychotic Treatment for Chinese First-Episode Schizophrenia.

ObjectiveTo investigate the gender differences in the efficacy and side effects of three frequently used antipsychotic medicines (risperidone, olanzapine, aripiprazole) for patients with first-episode schizophrenia during the first year of treatment.MethodsA total of 569 patients with first-episode schizophrenia were randomly assigned to risperidone, olanzapine, and aripiprazole groups. All patients were treated according to their actual clinical needs. Clinical efficacies were assessed by the Positive and Negative Symptom Scale (PANSS) and side effects were assessed by the Udvalg for Kliniske Undersogelser Side-Effect scale (UKU). All assessments were completed at baseline and at 1, 2, 3, 6, 9, and 12 months.ResultsMales had higher baseline PANSS total scores and PANSS negative and general pathological scores. No significant interactions were found between treatment time and gender in psychopathology improvements in all three groups. In the end of the first year, female patients receiving risperidone reported more dermatological symptoms (rashes) than males, female patients receiving olanzapine reported more autonomic side effects and dermatological symptoms than males, and female patients receiving aripiprazole reported more psychotic side effects than males.ConclusionGender differences exhibited in response to antipsychotic treatments for Chinese patients with first-episode schizophrenia. After the first year of antipsychotic treatment, drug-related side effects were more likely presented in female patients than male patients.

Relationship Between Gonadal Hormone Levels and Symptom Severity in Female Patients With Schizophrenia.

It is thought that sex-specific differences in schizophrenia may be associated with gonadal hormones, especially estrogen. This study aimed to investigate the relationship between follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin, estradiol, and progesterone serum levels and symptom severity during the menstrual cycle in female patients with schizophrenia. Serum samples were taken in the follicular and periovulatory phases from 32 female patients with schizophrenia; and FSH, LH, prolactin, estradiol, and progesterone levels were performed. Simultaneously, the patients were administered positive and negative symptom scale (PANSS), Calgary depression scale for schizophrenia (CDSS), and Hamilton anxiety rating scale (HAM-A). PANSS (z = -2.52, P < .001), HAM-A (z = -3.60, P < .001), and CDSS (z = -2.52, P = .012) scores were lower in the periovulatory phase than in the follicular phase. Negative correlations between FSH and PANSS positive symptom subscale (r = -0.393, P = .035), and between prolactin and PANSS total score (r = -0.406, P = .029) were detected. Hypoestrogenism should be studied more in patients with schizophrenia. Studies with large samples evaluating FSH, LH, prolactin, and progesterone together with estrogen are needed to be able to safely use gonadal hormones, which may be related to schizophrenia symptom severity, especially in patients who do not respond adequately to treatment.

Efficacy and safety of blonanserin transdermal patch in patients with schizophrenia: A 6-week randomized, double-blind, placebo-controlled, multicenter study

BackgroundBlonanserin is a second-generation antipsychotic used for the treatment of schizophrenia. This study determined the efficacy, safety and pharmacokinetics of a blonanserin transdermal patch in patients with acutely exacerbated schizophrenia. MethodsThis double-blind, multicenter, phase 3 study consisted of a 1-week observation period during which patients were treated with two patches of placebo, followed by a 6-week double-blind period where patients were randomized (1:1:1) to receive once-daily blonanserin 40 mg, blonanserin 80 mg, or placebo patches. The primary endpoint was the change from baseline in the total Positive and Negative Symptom Scale (PANSS) score. Safety assessments included treatment-emergent adverse events (TEAEs). ResultsBetween December 2014 and October 2018, patients were recruited and randomly assigned to blonanserin 40 mg (n = 196), blonanserin 80 mg (n = 194), or placebo (n = 190); of these, 77.2% completed the study. Compared with placebo, blonanserin significantly improved PANSS total scores at 6 weeks (least square mean [LSM] difference vs placebo: −5.6 with blonanserin 40 mg; 95% confidence interval [CI] −9.6, −1.6; adjusted p = 0.007, and − 10.4 with blonanserin 80 mg; 95% CI −14.4, −6.4; adjusted p < 0.001). Blonanserin was well tolerated; the most common TEAEs reported were application-site erythema and pruritus, akathisia, tremor, and insomnia. ConclusionsBlonanserin transdermal patch improved the symptoms of acute schizophrenia with acceptable tolerability.

Impact of personal rehabilitation treatment on life quality and curative effect of schizophrenia patients

Objective To explore the impact of the personal rehabilitation treatment on life quality and curative offect of the schizophrenia patients. Methods A total of 84 patients with chronic schizophrenia in Shanxi Rongjun Corelle Hospital from December 2016 January 2018 were randomly divided into intervention group and control group on the basis of random number table, the two groups received psychiatric routine therapy nursing and general entertainment therapy, and the intervention group received 8 weeks of individualized rehabilitation therapy on this basis.The Schizophrenics Quality of Life Scale(SQLS) and Positive and Negative Symptoms Scale(PANSS) were respectively used to evaluate the effect of the two groups before and after intervention. Results After 8 weeks of systematic social skills training, the scores of negative symptoms, general psychopathology and total PANSS score in the intervention group were (14.65±3.68)points, (24.21±3.23)points, (52.83±7.12)points, respectively, which in the control group were (21.82±4.25)points, (28.08±4.56)points, (60.67±9.52)points, respectively, the differences between the two groups were statistically significant(t=5.18, 3.35, 3.92, all P 0.05). The PANSS scores and total score in the intervention group after intervention had statistically significant differences compared with those before intervention (t=2.17, 5.98, 3.86, 4.13, all P<0.05). After the intervention training, the psychosocial score, motivation and energy score, symptoms and adverse reactions score, and total score of SQLS in the intervention group were (32.64±7.32)points, (39.45±10.87)points, (18.16±10.48)points, (90.34±24.17)points, which in the control group were (35.32±10.64)points, (43.82±12.43)points, (21.05±11.52)points, (98.25±32.29)points, respectively, and the differences between the two groups were statistically significant (t=2.46, 3.51, 3.12, 3.96, all P<0.05). The SQLS scores and total score in the intervention group after intervention had statistically significant differences compared with those before intervention(t=3.94, 4.72, 3.87, 5.01, all P<0.01). Conclusion The personal rehabilitation treatment can greatly promote the curative offect of patients with chronic schizophrenia, improve their life qualities. Key words: Rehabilitation; Schizophrenia; Quality of life; Treatment outcome; Mentally disabled persons

Study on risk factors of extrapyramidal symptoms induced by antipsychotics and its correlation with symptoms of schizophrenia

BackgroundExtrapyramidal symptoms (EPS) are one of the most common and neglected side effects during the treatment of schizophrenia. The risk factors of EPS in Chinese patients with schizophrenia and its...

Prevalence and clinical correlations of obsessive-compulsive symptoms in schizophrenia.

Obsessive compulsive symptoms are often present in persons with schizophrenia. Adequately powered studies to evaluate the effect of such symptoms in the course of the disorder, are few. We aimed to estimate the prevalence and type of obsessive-compulsive symptoms in persons with schizophrenia. We evaluated 200 outpatients with schizophrenia (DSM-V) on the Positive and Negative Symptom Scale (PANSS) and the Yale Brown Obsessive Compulsive Scale (YBOCS). Participants with or without obsessive compulsive symptoms were matched on age, gender and age of onset of schizophrenia. Appropriate analysis by comparisons and correlations were performed. Prevalence of obsessive-compulsive symptoms was 18.5% (n = 37/200). Most common obsession was contamination and compulsion was cleaning/washing with a prevalence of 51.35% and 63.33% respectively. There were no significant differences between the two groups on age, gender, marital status, residence, age of onset or total duration of illness of schizophrenia. The OC symptoms group had significantly higher general psychopathology and PANSS total scores. There was significant positive correlation between YBOCS total obsession scores (To) and total PANSS scores (r = 0.358) (p = 0.030), as well as PANSS general psychopathology subscale scores (Gt) (r = 0.395) (p = 0.016) and finally between total YBOCS scores (To + Tc) and PANSS positive subscale scores (Pt)(r = 0.344) (p = 0.037). There was a significant subgroup of schizophrenia patients (almost one fifth) who complained of obsessive-compulsive symptoms. This group reported significantly higher general psychopathology and could thus be said to be more seriously ill, in an adequately powered cross sectional study.

O8.2. DURATION OF UNTREATED PSYCHOSIS (DUP) IS ASSOCIATED WITH WORSE RESPONSE TO TREATMENT IN ANTIPSYCHOTIC NAïVE FIRST EPISODE PSYCHOSIS

BackgroundLonger duration of untreated psychosis (DUP) predicts poor functional outcomes in patients with schizophrenia. The results are not so clear when addressing effects on specific dimensions of symptoms, which may be due to confounding effects of previous antipsychotic treatment. We investigated the association between DUP, specific dimensions and response to treatment in a 10-week follow up study of patients at First-Episode of Psychosis (FEP) with no previous antipsychotic use.MethodsWe assessed 158 antipsychotic naïve individuals with first-episode psychosis, admitted to a psychiatric emergency service. Diagnosis was established according to the Structured Clinical Interview for DSM-IV (SCID). Symptom severity was measured with the Positive And Negative Symptoms Scale (PANSS) and the Clinical Global Impressions Scale (CGI). Functionality was assessed with the Global Assessment of Functioning Scale (GAF). All patients were treated with risperidone and reassessed after 10 weeks of treatment. For analyses, we performed non-parametric correlation tests (Spearman’s correlation).ResultsAt baseline, we did not find a correlation between DUP and symptom severity and functionality. After the follow-up, DUP became significantly correlated to both symptomatic and functional outcomes. DUP showed significant association with PANSS positive score (r=0.282; p=0.008), PANSS negative score (r=0.295; p=0.005), PANSS total score (r=0.258; p=0.017), CGI total (r=0.305; p=0.003) and GAF (r=-0.294; p=0.004). We also found a negative correlation between DUP and response to treatment considering 30% of reduction of PANSS’ scores (r=-0.288; p=0.027).DiscussionOur findings support that DUP does not affect the severity of illness at baseline, but modifies the response to treatment and clinical severity after 10 weeks. This finding suggests that longer exposition to psychosis might be involved in biological abnormalities that modulate the response to antipsychotics, which could mediate poor response to treatment.

T47. IS THERE A DIURNAL VARIATION IN PSYCHIATRIC SYMPTOMS IN SCHIZOPHRENIA?

BackgroundAnecdotally we have observed subgroups of schizophrenic patients who experienced a diurnal variation in a wide range of psychiatric symptomology. Such a pattern could have substantial ramifications in both clinical care and clinical trials. For example, two commonly used measures of symptom severity in clinical trials, the Positive and Negative Symptom Scale (PANSS) and the Negative Symptom Assessment Scale (NSA-16) contain numerous items that are rated based entirely or in part on observations of the subject during the interview. We hypothesized that inconsistency in the time of day of assessment in subjects whose symptoms were influenced by circadian rhythms could introduce an erratic “noise” element in the longitudinal measure of their symptoms.To investigate this hypothesis we compared the change in PANSS total score and individual PANSS items across consecutive visits by whether the assessments had been conducted at consistent vs. inconsistent times of day.Methods2109 individual subject visits from multiple schizophrenia clinical trials for which PANSS interview start time was available were included in the analysis. 1,764 pairs of consecutive PANSS interviews within individual subjects were identified and the time difference between the start times of the interviews were calculated. The absolute time difference was divided into quartiles and the first quartile (assessments least disparate in time) and the fourth quartile (assessments most disparate in time) were compared in the analyses. The mean absolute change in PANSS total and PANSS individual items between the consecutive visits was compared between the 2 groups using a t-test. Given the exploratory and hypothesis driven nature of the analysis we did not correct for multiple comparisons.ResultsThe average absolute difference in interview start times was 79.5 minutes. The group with assessments closest in time (N = 446) had their interviews start no later than 30 minutes apart while the group with assessments most disparate in time (N = 445) had their interview start with at least 170 minutes difference. Of the 30 PANSS items, items P4 (Excitement 0.33 vs. 0.44, p =0.0077), P7 (Hostility 0.31 vs. 0.47, p < 0.001), N5 (Difficulty in abstract thinking 0.28 vs. 0.35, p = 0.043), N7 (Stereotyped thinking0.26 vs. 0.35, p = 0.021) G1 (Somatic concern 0.34. vs. 0.43, p = 0.041), G2 (Anxiety 0.42 vs. 0.53, p = 0.019), G6 (Depression 0.38 vs.0.52, p = 0.0044), G7 (Motor retardation 0.28 vs. 0.37, p = 0.025), and G8 (Uncooperativeness 0.29 vs. 0.39, p = 0.02) had an absolute difference significantly higher in the disparate group than in the close group. The mean absolute difference in the PANSS total was 5.1(+/-5.8) in the close group and 5.9(+/-5.4) in the disparate group, (p = 0.08).DiscussionThe results demonstrate a statistically significant effect of variation in time of day on symptom severity. These findings underscore the risk of potential noise (erratic changes) in longitudinal assessment of symptom severity when ratings are done at different times of day. Moreover, it suggests that symptom severity assessed in a standard PANSS interview may not generalize over the entire day, much less over the standard one week rating period. This is important because many PANSS items are rated partially or entirely on the interview which may not be a representative “biopsy” of the subject’s mental state or behavior during the one week rating period. This highlights the potential remedies of more frequent or ecological measurements.Hufford et al (2014) demonstrated a statistically significant effect of variation in the time of day on signal from the MCCB cognitive battery. Our results confirm our anecdotal observations that severity of non-cognitive schizophrenic symptoms are impacted by circadian rhythms as well.

Development of Social Functioning Assessment Scale for People with Schizophrenia: validity and reliability study

Objective: Assessment of the level of social functioning is important especially for people with schizophrenia that has a chronic course of illness. The purpose of this study was to develop a culturally sensitive, user-friendly scale that could assess the social functioning of the people with schizophrenia living in Turkey. Methods: After examining the studies that assessed social functioning in people with mental illnesses and social habits of people living in the community, a 28-item scale was formed. The items of the form were discussed with patients with schizophrenia and their family members. Items, which were difficult to comprehend, were reevaluated and the form was finalized as Social Functioning Assessment Scale (SFAS). One hundred and forty-eight outpatients with schizophrenia or schizoaffective disorder were given the SFAS, Positive and Negative Symptoms Scale (PANSS), Clinical Global Impression-Severity (CGI-S), and Global Assessment of Functioning (GAF). At the same time, Social Functioning Scale (SFS) and SFAS were filled out by the relatives of the patients living together. SFAS was also given to 161 healthy subjects living in the community. For reliability analyses; internal consistency coefficient, item-total correla-tion, and test-retest reliability were assessed. For validity analyses; explanatory factor analysis, convergent, diver-gent, and discriminant validity were examined. Results: The data from 120 patients with schizophrenia and 28 with schizoaffective disorder was examined. Cronbach’s alpha coefficient for SFAS total score was 0.842. Kaiser-Meyer-Olkin value was 0.813, and Bartlett test was significant for factor analysis. In explanatory factor analysis, SFAS comprised of three factors (interpersonal relations and recreation, self-care, independent living) and they can explain 47% of the total variance. Occupational life could not get in any of the factors; however, since it was impor-tant for social functioning, it was added to the scale as the fourth factor. Total score of the SFAS filled out by the patients was significantly correlated with PANSS, CGI-S, GAF and SFS total score. There was a satisfactory corre-lation between the total score of SFAS filled out by the patients and relatives. There was a statistically significant difference between the SFAS scores of the patients and SFAS scores of the controls. Test-retest reliability of the SFAS-P was 0.874. Conclusion: Regarding the findings of the study, SFAS was considered a culturally sensitive, easy-to-use, valid and reliable instrument that objectively assesses the social functioning of the patients with schizo-phrenia.

Positive impact of prescribed physical activity on symptoms of schizophrenia: randomized clinical trial.

The purpose of this study was to examine functional capacity of cardio-respiratory system in patients with schizophrenia, and to evaluate the effects of 12 weeks prescribed physical activity on aerobic capacity and symptoms of schizophrenia. Study involved 80 hospitalized patients with any of the subtypes of schizophrenia (42 men, 38 women). They were divided into two groups: exercise and control group, both with 40 patients. Maximal aerobic capacity (VO2 max) as an indicator of cardiovascular fitness has been obtained by cardiopulmonary stress test on a treadmill. Twelve weeks program of prescribed physical activity (45 minutes, four times per week) was made for every patient individually. Patients in exercise group practiced in training zone between 65 and 75% of their maximum heart rate (HR). Target HR was controlled by Polar F4 monitors. Symptoms of schizophrenia were measured by using Positive and Negative Symptoms Scale (PANSS). Before the exercise program was introduced, measured VO2 max was significantly lower in patients with schizophrenia, than the expected average value in matched healthy subjects (p<0.001). After twelve weeks, patients in exercise group showed a significant increase of VO2max (p=0.002), and significantly higher level of VO2max compared to the control group (p=0.000). Significant differences were also observed on PANSS general psychopathology subscale (p=0.007) and on PANSS total score (p=0.001). The pharmacotherapy and exercise had influence on PANSS general psychopathology (p=0.002) and PANSS total score (p=0.001). Individuals with schizophrenia have lower levels of aerobic capacity compared to general population. Prescribed physical activity significantly improves aerobic capacity in people with schizophrenia and it is effective in amelioration of some psychiatric symptoms. Prescribed physical activity could be an effective adjunctive treatment for patients with schizophrenia, not only for prevention and treatment of comorbidities, but also having an impact on symptoms of schizophrenia.

Efficacy and Safety of Lurasidone in Adolescents with Schizophrenia: A 6-Week, Randomized Placebo-Controlled Study.

Objective: To evaluate the efficacy and safety of lurasidone in acutely symptomatic adolescent patients with schizophrenia.Methods: Patients aged 13–17 years were randomly assigned to 6 weeks of double-blind, fixed-dose lurasidone (40 or 80 mg/day) or placebo. Primary and key secondary efficacy measures were change from baseline to week 6 in the Positive and Negative Symptom Scale (PANSS) total score and Clinical Global Impressions-Severity (CGI-S) score, respectively, using mixed model for repeated measurement (MMRM) analysis. The proportion of patients achieving treatment response at endpoint, based on ≥20% reduction in PANSS total score, was analyzed using a logistic regression model.Results: Least-squares (LS) mean change in PANSS total score from baseline to week 6 was −18.6 with lurasidone 40 mg/day (N = 108; p < 0.001 vs. placebo; effect size = 0.51), −18.3 with lurasidone 80 mg/day (N = 106; p < 0.001 vs. placebo; effect size = 0.48), and −10.5 with placebo (N = 112). Similarly, LS mean change in CGI-S score from baseline to week 6 was significantly greater with lurasidone 40 mg/day (−1.0; p < 0.001; effect size = 0.49) and 80 mg/day (−0.9; p = 0.0015; effect size = 0.45) compared with placebo (−0.5). A significantly higher proportion of patients met responder criteria on lurasidone 40 and 80 mg/day versus placebo (63.9% and 65.1% vs. 42.0%; p < 0.001 for both comparisons). The rate of study discontinuation was 10.3% in lurasidone-treated and 17.7% in placebo-treated patients. The most common adverse events (incidence ≥5% in either lurasidone dose group and at least twice the rate of placebo) for lurasidone 40 mg/day, 80 mg/day, and placebo, respectively, were nausea (12.7%, 14.4%, and 2.7%), somnolence (9.1%, 11.5%, and 5.4%), akathisia (9.1%, 8.7%, and 1.8%), vomiting (8.2%, 6.7%, and 1.8%), and sedation (5.5%, 1.9%, and 1.8%). Treatment with lurasidone was not associated with clinically meaningful effects on body weight, lipids, measures of glycemic control, or prolactin.Conclusions: In this 6-week study, lurasidone at doses of 40 and 80 mg/day demonstrated statistically significant and clinically meaningful symptom improvement in adolescent patients with schizophrenia. Lurasidone was generally well tolerated with few effects on weight and metabolic parameters, consistent with findings in adult patients with schizophrenia.