scholarly journals Clinical efficacy and safety of lurasidone in schizophrenia: 8 week randomized double blind active controlled trial

2020 ◽  
Vol 7 (5) ◽  
pp. 817
Author(s):  
Unnati Saxena ◽  
Anuradha Nischal ◽  
Anil Nischal ◽  
Abbas Ali Mahdi ◽  
Manu Agarwal ◽  
...  
Keyword(s):  
Clinical Efficacy ◽  
Side Effect ◽  
Rating Scale ◽  
Controlled Trial ◽  
Treatment Modalities ◽  
First Episode ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Syndrome Scale ◽  
Negative Syndrome

Background: Schizophrenia comprises a group of disorders with heterogeneous etiologies, it includes patients whose clinical presentations, treatment response, and courses of illness vary. This study was carried to study the clinical efficacy and safety of Lurasidone versus Risperidone on psychopathology and cognition in patients with first episode of schizophrenia.Methods: Patients diagnosed with first episode of schizophrenia were enrolled in the study. Patients were randomized to 80 mg/d (n = 27) of Lurasidone or 6mg/d (n = 27) of Risperidone. Efficacy assessments included Positive and Negative Syndrome Scale (PANSS) scores, Schizophrenia cognition rating scale (SCoRS). IL-6 estimation was done and safety assessment was done using UKU side effect rating scale.Results: During the eight weeks of study; significant improvement was observed in PANSS total and all its subscale scores with both Lurasidone and Risperidone. Mean change in PANSS scores were not significant between the groups (-32.93 vs -35.33 p>0.05). Mean change in SCoRS scores were significantly higher in Lurasidone group as compared to risperidone group (-8.43 vs -2.34, p<0.001). Significant reduction in the IL-6 levels with both the groups but mean change in IL-6 levels were not significant between the group (-10.47 vs -8.31, p>0.05). UKU side effect rating scores were significantly higher with Risperidone as compared to Lurasidone (p<0.001).Conclusions: Lurasidone is as effective as Risperidone in improving psychopathology in patient of schizophrenia. Lurasidone proved more efficacious in improving cognition as compared to Risperidone. Both the treatment modalities are efficacious in lowering IL-6 levels. Lurasidone causes less adverse effects as compared to Risperidone.

scholarly journals Resveratrol Adjunct Therapy for Negative Symptoms in Patients With Stable Schizophrenia: A Double-Blind, Randomized Placebo-Controlled Trial

2020 ◽  
Vol 23 (12) ◽  
pp. 775-782
Author(s):  
Areoo Samaei ◽  
Kamyar Moradi ◽  
Sayna Bagheri ◽  
Amir Ashraf-Ganjouei ◽  
Rosa Alikhani ◽  
...  
Keyword(s):  
Negative Symptoms ◽  
Rating Scale ◽  
Controlled Trial ◽  
Subscale Score ◽  
Double Blind ◽  
General Psychopathology ◽  
Syndrome Scale ◽  
Broad Variety ◽  
Negative Syndrome ◽  
To Receive

Abstract Background Patients with schizophrenia can generally manifest a broad variety of primary negative symptoms. The current study aimed to assess the efficacy and tolerability of resveratrol add-on therapy in the treatment of negative symptoms in patients with stable schizophrenia. Methods In a randomized, double-blind, and placebo-controlled setting, schizophrenia patients were assigned to receive either 200 mg/d resveratrol or matched placebo in addition to a stable dose of risperidone for 8 weeks. Patients were assessed using the positive and negative syndrome scale, the extrapyramidal symptom rating scale, and Hamilton Depression Rating Scale over the trial period. The primary outcome was considered as the change in positive and negative subscale score from baseline to week 8 between the treatment arms. Results A total 52 patients completed the trial (26 in each arm). Baseline characteristics of both groups were statistically similar (P  &gt; .05). Despite the statistically similar behavior of positive symptoms between the groups across time (Greenhouse-Geisser corrected: F = 1.76, df = 1.88, P = .180), the resveratrol group demonstrated greater improvement in negative, general psychopathology, and total scores (Greenhouse-Geisser corrected: F = 12.25, df = 2.04, P &lt; .001; F = 5.42, df = 1.56, P = .011; F = 7.64, df = 1.48, P = .003). HDRS scores and its changes, ESRS score, and frequency of other complications were not significantly different between resveratrol and placebo groups. Conclusion Adding resveratrol to risperidone can exhibit remarkable efficacy and safety in terms of management of schizophrenia-related negative symptoms.

scholarly journals Duration of untreated psychosis of first-episode psychotic disorders in Yogyakarta, Indonesia

2019 ◽  
Vol 7 (2) ◽  
pp. 61-64
Author(s):  
Carla R. Marchira ◽  
Irwan Supriyanto
Keyword(s):  
Psychotic Disorders ◽  
Rating Scale ◽  
First Episode ◽  
Medical Facility ◽  
Duration Of Untreated Psychosis ◽  
Global Assessment Of Functioning ◽  
Global Functioning ◽  
Syndrome Scale ◽  
Negative Syndrome ◽  
Gaf Scores

Introduction: Duration of untreated psychosis (DUP) is an important predictor for prognosis in first episode of psychotic disorders. Caregivers often seek help from alternative healers first and health professional later. These would delay proper treatments for the patients, resulting in more severe symptoms and lower functioning on their visit to medical facility. The present study aims to find the association between DUP, symptoms severity, and global functioning in patients with first-episode psychotic disorders. Methods: We identified 100 patients with first episode of psychotic disorders and their caregivers. The instruments used were Brief Psychotic Rating Scale (BPRS), Positive and Negative Syndrome Scale (PANSS), Premorbid Schizoid-Schizotypal Traits (PSST), and Global Assessment of Functioning (GAF). Results: There were no significant association between BPRS, PANSS, PSST, and GAF scores and DUP in our subjects. Nevertheless, we found that men had significantly longer DUP compared to women. Conclusion: We found significant association between sex and DUP in this study. Longer DUP leads to delayed treatments and poorer prognosis. Further study is required to confirm our finding.

scholarly journals Sodium Nitroprusside Infusion for the Treatment of Schizophrenia

2020 ◽  
Vol 1 (1) ◽  
Author(s):  
Mark Weiser ◽  
Daisy Zamora ◽  
Linda Levi ◽  
Valentin Matei ◽  
Ilan Gonen ◽  
...  
Keyword(s):  
Sodium Nitroprusside ◽  
Wide Spectrum ◽  
Controlled Trial ◽  
Study Groups ◽  
Current Evidence ◽  
Double Blind ◽  
Syndrome Scale ◽  
Meta Analyses ◽  
A Site ◽  
Negative Syndrome

Abstract One previous small single-center clinical trial showed that a single intravenous administration of sodium nitroprusside added-on to antipsychotics improved a wide spectrum of schizophrenia (SCZ) symptoms more than placebo, and the improvement persisted for 4 weeks after infusion even though no additional drug was given. Our study attempted to replicate these data in a 4-week, add-on, double-blind, randomized, placebo-controlled trial on 20 patients performed in a site in Romania and a site in Moldova. This study’s sample size and protocol were identical to the previous trial, including patients with a diagnosis of SCZ, within the first 5 years after diagnosis. Patients recruited needed to have a baseline total positive and negative syndrome scale (PANSS) score of 60 or above. Ten participants received a single dose of 0.5 µg/kg/min intravenous sodium nitroprusside over 4 hours, and 10 participants received matching placebo infusion, added-on to antipsychotics. The primary outcomes were the PANSS total score and the PANSS negative subscale. There were no significant between-group differences in PANSS total scores or negative subscale scores during the infusion on daily evaluations for the next 7 days nor on weekly evaluations at weeks 2, 3, and 4. No significant differences were found between the 2 study groups in adverse events. Meta-analyses including all 5 published randomized controlled trials on the topic, representing 155 subjects, do not show a statistically significant benefit of sodium nitroprusside. We conclude that the current evidence does not support the efficacy of sodium nitroprusside in the treatment of SCZ.

scholarly journals Efficacy and safety of Jie-du-qing-nao granules for first-episode schizophrenics: study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
Ziyan Li ◽  
Yanzhe Ning ◽  
Pei Chen ◽  
Yi Zhang ◽  
Dongqing Yin ◽  
...  
Keyword(s):  
Negative Symptoms ◽  
Complete Blood Count ◽  
Controlled Trial ◽  
First Episode ◽  
Control Group ◽  
Study Group ◽  
Efficacy And Safety ◽  
Clinical Trial Registry ◽  
Symptom Scale ◽  
Double Blind

Abstract BackgroundAt present, the focus and difficulty of schizophrenia (SCZ) treatment is to improve cognitive function and negative symptoms. Jie-du-qing-nao granules(JQG) , a traditional Chinese medicine(TCM) prescription , has a good clinical effectiveness in enhancing the cognition and negative symptoms of patients with SCZ. However, its clear effectiveness and safety have not been adequately supported by clinical studies. The main objective of this study is to explore the efficacy and safety of JQG for first-episode schizophrenics.Methods/designThis trial is a prospective, randomized, single-centered, parallel-controlled clinical study with double-blind design. A total of 96 eligible participants will be randomly assigned to either the study group or the control group in a ratio of 1:1. Participants allocated to the study group will receive JQG and aripiprazole, control group will receive placebo and aripiprazole. The treatment course will last 12 weeks, with follow-up every 4 weeks. Outcome measurements include Positive and Negative Syndrome Scale (PANSS), self face test , MATRICS Consensus Cognitive Battery (MCCB), TNFα, IL-6, IL-1β, BDNF, vital signs, complete blood count, liver and kidney function tests, urinalysis, and electrocardiograph. Adverse reactions will be evaluated using the Treatment Emergent Symptom Scale (TESS).DiscussionThis study will provide evidence for the efficacy and safety of JQG as a complementary approach, which can be initiated following with antipsychotics therapy. Trial registration Chinese Clinical Trial Registry, ID: ChiCTR1900028250 . Registered on December 16, 2019, http://www.chictr.org.cn/edit.aspx?pid=41880&htm=4 .

scholarly journals Efficacy and safety of once-monthly Risperidone ISM® in schizophrenic patients with an acute exacerbation

2020 ◽  
Vol 6 (1) ◽  
Author(s):  
Christoph U. Correll ◽  
Robert E. Litman ◽  
Yuriy Filts ◽  
Jordi Llaudó ◽  
Dieter Naber ◽  
...  
Keyword(s):  
Acute Exacerbation ◽  
Safety Information ◽  
Severity Of Illness ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Efficacy Outcome ◽  
Syndrome Scale ◽  
Schizophrenic Patients ◽  
Negative Syndrome

AbstractTo evaluate the efficacy and safety of Risperidone ISM® against placebo in patients with acute exacerbation of schizophrenia. A multicenter, randomized, double-blind, placebo-controlled study was conducted between June 2017 and December 2018 (NCT03160521). Eligible patients received once-monthly intramuscular injections of Risperidone ISM® (75 or 100 mg) or placebo for 12 weeks. The primary efficacy outcome was change in Positive and Negative Syndrome Scale (PANSS) total score from baseline to week 12. The key secondary efficacy outcome was change from baseline in Clinical Global Impressions-Severity of Illness scale (CGI-S) score. Altogether, 438 patients were randomized (1:1:1) and 390 included in the modified ITT efficacy set. The PANSS total score (mean difference, 95% CI) improved significantly from baseline to day 85 with Risperidone ISM® 75 and 100 mg, with placebo-adjusted differences of −13.0 (95% CI, −17.3 to −8.8); (p < 0.0001), and −13.3 (−17.6 to −8.9); (p < 0.0001), respectively. Significantly improved mean changes were also obtained for CGI-S score from baseline to day 85 for both doses of Risperidone ISM® compared with placebo −0.7 (−1.0 to −0.5); p < 0.0001, for both doses. The statistically significant improvement for both efficacy outcomes were observed as early as 8 days after first injection. The most frequently reported treatment-emergent adverse events were increased blood prolactin (7.8%), headache (7.3%), hyperprolactinemia (5%), and weight increase (4.8%). Neither new nor unexpected relevant safety information was recorded. Risperidone ISM® provided rapid and progressive reduction of symptoms in patients with acutely exacerbated schizophrenia without need of oral risperidone supplementation or loading doses. Both doses were safe and well tolerated.

The Efficacy and Safety of Lower Doses of Aripiprazole for the Treatment of Patients with Acute Exacerbation of Schizophrenia

CNS Spectrums ◽  
2006 ◽  
Vol 11 (9) ◽  
pp. 691-702 ◽  
Author(s):  
Andrew J. Cutler ◽  
Ronald N. Marcus ◽  
Sterling A. Hardy ◽  
Amy O'Donnell ◽  
William H. Carson ◽  
...  
Keyword(s):  
Acute Exacerbation ◽  
Primary Outcome ◽  
Primary Outcome Measure ◽  
Efficacy And Safety ◽  
Inpatient Hospitalization ◽  
Double Blind ◽  
Acute Relapse ◽  
Syndrome Scale ◽  
Safety Parameters ◽  
Negative Syndrome

ABSTRACTIntroductionEfficacy and safety of aripiprazole administered at doses lower than those previously studied systematically were investigated in patients with acute exacerbation of schizophrenia.MethodsIn this double-blind, multicenter study, 367 patients requiring inpatient hospitalization for acute relapse of schizophrenia were randomized to one of three fixed doses of aripiprazole (2, 5, or 10 mg/day) or placebo for 6 weeks. Efficacy and safety parameters were assessed weekly. Primary outcome measure was mean change from baseline in Positive and Negative Syndrome Scale (PANSS)Total score at endpoint.ResultsAripiprazole 10 mg/day produced statistically significantly greater improvements from baseline compared with placebo for PANSS Total at endpoint (−11.3 vs −5.3; P=.03) and at weeks 2–5. Aripiprazole 5 mg/day did not produce significantly greater improvement in PANSS Total compared with placebo at endpoint, although significant differences were seen at weeks 3–5. No statistically significant improvements compared with placebo were achieved with aripiprazole 2 mg/day at any time points. All aripiprazole doses were well tolerated. Aripiprazole was not associated with significant extrapyramidal symptoms.ConclusionWhile aripiprazole 5 mg/day warrants further study, the 10 mg/day dose provides effective and well-tolerated therapy for management of acute psychosis in patients with schizophrenia.

scholarly journals Prevalence and correlates of antipsychotic polypharmacy among outpatients with schizophrenia attending a tertiary psychiatric facility in Nigeria

2016 ◽  
Vol 7 (1) ◽  
pp. 3-10 ◽  
Author(s):  
Nosa Godwin Igbinomwanhia ◽  
Sunday Osasu Olotu ◽  
Bawo Onesirosan James
Keyword(s):  
Psychosocial Functioning ◽  
Side Effect ◽  
Negative Symptoms ◽  
Rating Scale ◽  
Cross Sectional Study ◽  
Global Assessment Of Functioning ◽  
Psychiatric Facility ◽  
Cross Sectional ◽  
Syndrome Scale ◽  
Negative Syndrome

Background: The study aimed to determine the prevalence, pattern and correlates of antipsychotic polypharmacy (APP) among outpatients with schizophrenia attending a tertiary psychiatric facility in Nigeria. Method: A cross-sectional study of 250 patients with schizophrenia attending the outpatient clinic of a regional tertiary psychiatric facility in Nigeria was undertaken. They were administered a sociodemographic questionnaire, the Positive and Negative Syndrome Scale (PANSS), the Global Assessment of Functioning (GAF) scale and the Liverpool University Side Effects Rating Scale (LUNSERS). Results: Of the 250 subjects interviewed, 176 (70.4%) were on APP. APP was significantly associated with higher prescribed chlorpromazine equivalent doses of antipsychotics ( p < 0.001), increased frequency of dosing ( p < 0.001), negative symptoms ( p < 0.01), poorer functioning ( p = 0.04) and greater side-effect burden ( p = 0.04). Conclusion: The APP rate reported from this study is high. Clinicians should be mindful of its impact on dosage and side-effect profiles as APP use is associated with negative symptoms and poor psychosocial functioning.

scholarly journals Premorbid functioning and treatment response in recent-onset schizophrenia

2006 ◽  
Vol 189 (1) ◽  
pp. 31-35 ◽  
Author(s):  
Jonathan Rabinowitz ◽  
Philip D. Harvey ◽  
Marielle Eerdekens ◽  
Michael Davidson
Keyword(s):  
Treatment Response ◽  
Rating Scale ◽  
Extrapyramidal Symptoms ◽  
Response To Treatment ◽  
First Episode ◽  
Double Blind ◽  
Recent Onset ◽  
Syndrome Scale ◽  
Premorbid Functioning ◽  
The Relationship

BackgroundInvestigating the relationship between premorbid functioning and treatment response in schizophrenia is relevant to understanding the illness and predicting treatment outcomes.AimsTo examine the relationship between premorbid characteristics and treatment response of people with recent-onset schizophrenia.MethodData came from a large, double-blind trial of recent-onset psychosis treated with a flexible dose of risperidone or haloperidol. Median treatment length was 206 days. Premorbid functioning was categorised using the Cannon-Spoor Premorbid Adjustment Scale.ResultsThere were significant differences between the premorbid groups on change on the Positive and Negative Syndrome Scale, Clinical Global Impression severity and cognitive functioning and Extrapyramidal Symptoms Rating Scale. Patients in the ‘stable–good’ premorbid group (n=251) improved more than those in the ‘stable–poor’ (n=198) and ‘declining’ (n=81) groups. The ‘stable–good’ group received the lowest doses of antipsychotic and had the least extrapyramidal symptoms. Patients in the declining’ group had the highest dosages and the most extrapyramidal symptoms.ConclusionsIn first-episode psychosis good premorbid functioning is associated with better response to treatment and fewer extrapyramidal symptoms.

scholarly journals Clinical Efficacy and Safety of Benjakul Remedy Extract for Treating Primary Osteoarthritis of Knee Compared with Diclofenac: Double Blind, Randomized Controlled Trial

2017 ◽  
Vol 2017 ◽  
pp. 1-9
Author(s):  
Patamaporn Rachawat ◽  
Piya Pinsornsak ◽  
Puritat Kanokkangsadal ◽  
Arunporn Itharat
Keyword(s):  
Clinical Efficacy ◽  
Safety Issue ◽  
Controlled Trial ◽  
Clinical Signs ◽  
Signs And Symptoms ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Primary Osteoarthritis ◽  
Clinical Signs And Symptoms

Background. The purpose of this study was to investigate the clinical efficacy and safety of Benjakul (BJK) extract for treating primary osteoarthritis (OA) of the knee compared with diclofenac. Methods. A phase 2, double blind, randomized, and controlled study was conducted. The BJK group received 300 mg of BJK extract per day, while another group received 75 mg of diclofenac per day. All patients were followed up at 14 and 28 days. The changing of visual analogue scale (VAS) for pain, 100-meter walking times, the modified Thai WOMAC index scores, and the global assessment were evaluated for efficacy. For safety issue, clinical signs and symptoms, complete physical examination, and renal and liver function were evaluated. Results. 39 and 38 patients for BJK extract group and diclofenac group were evaluated. For efficacy, all patients from both groups reported a decrease in the VAS pain score and 100-meter walking times but only the diclofenac group showed significant reduction of both measurements when compared with day 0. The modified Thai WOMAC scores of both groups were significantly reduced from baseline. However, all efficacy outcomes were not significantly different for both groups. For safety outcomes, the patients from both groups had no severe adverse events reported and only BJK had no toxicity in renal and liver functions. Conclusions. The BJK remedy extract showed equal clinical efficacy in relieving symptoms of OA knee when compared with diclofenac.

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