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 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.

Safety of phosphatidylserine containing omega3 fatty acids in ADHD children: A double-blind placebo-controlled trial followed by an open-label extension

2013 ◽  
Vol 28 (6) ◽  
pp. 386-391 ◽  
Author(s):  
I. Manor ◽  
A. Magen ◽  
D. Keidar ◽  
S. Rosen ◽  
H. Tasker ◽  
...  
Keyword(s):  
Fatty Acids ◽  
Rating Scale ◽  
Controlled Trial ◽  
Study Groups ◽  
Open Label ◽  
Double Blind ◽  
Blood Biochemical ◽  
Study Results ◽  
Open Label Extension ◽  
Safety Parameters

AbstractObjective:To evaluate the safety of phosphatidylserine (PS) enriched with omega3 fatty acids, mainly eicosapentaenoic (PS-Omega3) in children with attention-deficit hyperactivity disorder (ADHD).Methods:Two hundred children diagnosed with ADHD were randomised to receive either PS-Omega3 (300 mg PS-Omega3/day) or placebo for 15 weeks. One hundred and fifty children continued into an open-label extension for an additional 15 weeks in which they all consumed PS-Omega3 (150 mg PS-Omega3/day). Standard blood biochemical and haematological safety parameters, blood pressure, heart rate, weight and height were evaluated. Adverse events and the Side Effect Rating Scale were also assessed.Results:One hundred and sixty-two participants completed the double-blind phase. No significant differences were noted between the two study groups in any of the safety parameters evaluated. One hundred and forty participants completed the open-label phase. At the end of this phase, no significant changes from baseline were observed in any of the studied parameters among participants who consumed PS-Omega3 for 30 weeks.Conclusions:Study results demonstrate that consumption of PS-Omega3 by children with ADHD, as indicated in a 30-week evaluation period, is safe and well tolerated, without any negative effect on body weight or growth.

scholarly journals Ligilactobacillus salivarius PS2 Supplementation during Pregnancy and Lactation Prevents Mastitis: A Randomised Controlled Trial

2021 ◽  
Vol 9 (9) ◽  
pp. 1933
Author(s):  
Esther Jiménez ◽  
Susana Manzano ◽  
Dietmar Schlembach ◽  
Krzysztof Arciszewski ◽  
Rocio Martin ◽  
...  
Keyword(s):  
Placebo Group ◽  
Post Partum ◽  
Controlled Trial ◽  
Late Pregnancy ◽  
Probiotic Strain ◽  
Study Groups ◽  
Rank Test ◽  
Double Blind ◽  
Pregnancy And Lactation ◽  
Randomised Controlled

Mastitis is considered one of the main reasons for unwanted breastfeeding cessation. This study aimed to investigate the preventive effect of the probiotic strain Ligilactobacillus salivarius PS2 on the occurrence of mastitis in lactating women. In this multicountry, multicenter, randomized, double-blind, placebo-controlled trial, 328 women were assigned to the probiotic or the placebo group. The intervention started from the 35th week of pregnancy until week 12 post-partum. The primary outcome was the incidence (hazard) rate of mastitis, defined as the presence of at least two of the following symptoms: breast pain, breast erythema, breast engorgement not relieved by breastfeeding, and temperature > 38 °C. The probability of being free of mastitis during the study was higher in the probiotic than in the placebo group (p = 0.022, Kaplan–Meier log rank test) with 9 mastitis cases (6%) vs. 20 mastitis cases (14%), respectively. The hazard ratio of the incidence of mastitis between both study groups was 0.41 (0.190–0.915; p = 0.029), indicating that women in the probiotic group were 58% less likely to experience mastitis. In conclusion, supplementation of L. salivarius PS2 during late pregnancy and early lactation was safe and effective in preventing mastitis, which is one of the main barriers for continuing breastfeeding.

scholarly journals Effect of a single preoperative dose of oral antibiotic to reduce the incidence of surgical site infection following below-knee dermatological flap and graft repair

2019 ◽  
pp. 28-35 ◽  
Author(s):  
Helena Rosengren ◽  
Clare Heal ◽  
Petra Buettner
Keyword(s):  
Surgical Site Infection ◽  
Antibiotic Prophylaxis ◽  
Controlled Trial ◽  
Study Groups ◽  
High Dose ◽  
Antibiotic Administration ◽  
Oral Antibiotic ◽  
Site Infection ◽  
Double Blind

Background: Surgical site infection (SSI) rates for below-knee dermatological surgery are unacceptably high, particularly following complex flap and graft closures. The role of antibiotic prophylaxis for these surgical cases is uncertain. Objective: To determine whether SSI following complex dermatological closures on the leg could be reduced by antibiotic prophylaxis administered as a single oral preoperative dose. Methods: A total of 115 participants were randomized to 2 g of oral cephalexin or placebo 40-60 minutes prior to surgical incision in a prospective, randomized, double-blind, placebo-controlled trial at a primary care skin cancer clinic in North Queensland, Australia. Results: Overall 17/55 (30.9%) controls and 14/55 (25.5%) intervention participants developed infection (P = 0.525). There was no difference between the study groups in adverse symptoms that could be attributed to high-dose antibiotic administration (P = 1).

scholarly journals Relationships between pharmacotherapy-induced metabolic changes and improved psychopathology in schizophrenia: data from a mirtazapine and first-generation antipsychotics combination trial

2013 ◽  
Vol 16 (7) ◽  
pp. 1661-1666 ◽  
Author(s):  
Viacheslav Terevnikov ◽  
Jan-Henry Stenberg ◽  
Jari Tiihonen ◽  
Evgeni Chukhin ◽  
Marina Joffe ◽  
...  
Keyword(s):  
Body Weight ◽  
Weight Gain ◽  
Side Effects ◽  
First Generation ◽  
Metabolic Effects ◽  
Open Label ◽  
Double Blind ◽  
Cholesterol Levels ◽  
Syndrome Scale ◽  
Negative Syndrome

Abstract Clinical efficacy and metabolic side-effects of antipsychotics seem to correlate with each other. In this study, interrelationship of similar metabolic effects of mirtazapine and its earlier reported desirable effects on psychopathology in first-generation antipsychotics (FGAs)-treated schizophrenia were explored. Symptomatic FGAs-treated patients with schizophrenia received a 6-wk double-blind treatment with add-on mirtazapine (n = 20) or placebo (n = 16), followed by a 6-wk open-label mirtazapine treatment. Mirtazapine (but not placebo) induced an increase in body weight and cholesterol levels. The latter was associated with a clinical improvement in all (sub)scales of the Positive and Negative Syndrome Scale [PANSS; an increase of cholesterol by 1 mmol/l predicted 7 points reduction on the PANSS total score (r = 0.85, p = 0.001)]. In schizophrenia, mirtazapine-induced weight gain and increase of total cholesterol are associated with the improved efficacy of mirtazapine-FGAs combination – a novel observation with possible clinical and theoretical implications.

scholarly journals Rapid acute treatment of agitation in individuals with schizophrenia: multicentre, randomised, placebo-controlled study of inhaled loxapine

2011 ◽  
Vol 198 (1) ◽  
pp. 51-58 ◽  
Author(s):  
Michael D. Lesem ◽  
Tram K. Tran-Johnson ◽  
Robert A. Riesenberg ◽  
David Feifel ◽  
Michael H. Allen ◽  
...  
Keyword(s):  
Acute Treatment ◽  
Phase Iii ◽  
Controlled Study ◽  
Primary Efficacy ◽  
Double Blind ◽  
End Point ◽  
Syndrome Scale ◽  
Parallel Group ◽  
Negative Syndrome ◽  
Clinical Global Impression Improvement

BackgroundThere is a need for a rapid-acting, non-injection, acute treatment for agitation.AimsTo evaluate inhaled loxapine for acute treatment of agitation in schizophrenia.MethodThis phase III, randomised, double-blind, placebo-controlled, parallel-group study (ClinicalTrials.gov number NCT00628589) enrolled 344 individuals who received one, two or three doses of inhaled loxapine (5 or 10 mg) or a placebo. Lorazepam rescue was permitted after dose two. The primary efficacy end-point was change from baseline in Positive and Negative Syndrome Scale–Excited Component (PANSS–EC) 2 h after dose one. The key secondary end-point was Clinical Global Impression–Improvement scale (CGI–I) score 2 h after dose one.ResultsInhaled loxapine (5 and 10 mg) significantly reduced agitation compared with placebo as assessed by primary and key secondary end-points. Reduced PANSS–EC score was evident 10 min after dose one with both 5 and 10mg doses. Inhaled loxapine was well tolerated, and the most common adverse events were known effects of loxapine or minor oral effects common with inhaled medications.ConclusionsInhaled loxapine provided a rapid, well-tolerated acute treatment for agitation in people with schizophrenia.

scholarly journals The effect of sodium nitroprusside on psychotic symptoms and spatial working memory in patients with schizophrenia: a randomized, double-blind, placebo-controlled trial

2016 ◽  
Vol 46 (16) ◽  
pp. 3443-3450 ◽  
Author(s):  
J. M. Stone ◽  
P. D. Morrison ◽  
I. Koychev ◽  
F. Gao ◽  
T. J. Reilly ◽  
...  
Keyword(s):  
Working Memory ◽  
Sodium Nitroprusside ◽  
Rating Scale ◽  
Spatial Working Memory ◽  
Controlled Trial ◽  
Psychotic Symptoms ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Beneficial Effects ◽  
Psychiatric Rating Scale

BackgroundSodium nitroprusside (SNP) has been reported to rapidly reduce psychotic symptoms in patients with schizophrenia. This has the potential to revolutionize treatment for schizophrenia. In this study, we tested the hypothesis that SNP leads to a reduction in psychotic symptoms and an improvement in spatial working memory (SWM) performance in patients with schizophrenia.MethodThis was a single-centre, randomized, double-blind, placebo-controlled trial performed from 27 August 2014 to 10 February 2016 (clinicaltrials.gov identifier: NCT02176044). Twenty patients with schizophrenia aged 18–60 years with a diagnosis of schizophrenia or schizoaffective disorder were recruited from psychiatric outpatient clinics in the South London and Maudsley NHS Trust, London, UK. Baseline symptoms were measured using the Positive and Negative Syndrome Scale (PANSS) and the 18-item Brief Psychiatric Rating Scale (BPRS-18), and SWM was assessed using the CANTAB computerized test. Participants received either an infusion of SNP (0.5 μg/kg per min for 4 h) or placebo and were re-assessed for symptoms and SWM performance immediately after the infusion, and 4 weeks later.ResultsSNP did not lead to any reduction in psychotic symptoms or improvement in SWM performance compared to placebo.ConclusionsAlthough this study was negative, it is possible that the beneficial effects of SNP may occur in patients with a shorter history of illness, or with more acute exacerbation of symptoms.

scholarly journals Asenapine for the Treatment of Psychotic Disorders

2016 ◽  
Vol 62 (2) ◽  
pp. 123-137 ◽  
Author(s):  
Catherine Orr ◽  
Santosh Deshpande ◽  
Sonja Sawh ◽  
Philip M. Jones ◽  
Kamini Vasudev
Keyword(s):  
Clinical Trials ◽  
Adverse Effects ◽  
Psychotic Disorders ◽  
Randomized Clinical Trials ◽  
Current Evidence ◽  
Metabolic Outcomes ◽  
Syndrome Scale ◽  
Efficacy Measures ◽  
Clinically Significant ◽  
Negative Syndrome

Objective: A systematic review was conducted to examine the efficacy, tolerability, and acceptability of asenapine compared with other antipsychotics in the treatment of psychotic disorders. Methods: Four databases, 8 trial registries, and conference presentations were searched for randomized clinical trials of asenapine versus any comparator for the treatment of any psychotic illness. Primary outcome measures were changes in the Positive and Negative Syndrome Scale (PANSS) total score and the incidence of withdrawal due to adverse effects. Results: Eight randomized clinical trials, encompassing 3765 patients, that compared asenapine with placebo ( n = 5) and olanzapine ( n = 3) were included. No differences were found between asenapine and olanzapine in terms of changes to PANSS total or PANSS negative subscale scores. Patients taking asenapine were more likely to experience worsening schizophrenia and/or psychosis than were those taking olanzapine. No differences were found between asenapine and olanzapine in rates of discontinuation due to adverse drug reactions or lack of efficacy, but those taking asenapine had higher rates of withdrawal for any reason than those taking olanzapine. Asenapine caused less clinically significant weight gain or increases in triglycerides than olanzapine and was more likely to cause extrapyramidal symptoms than olanzapine. In comparison to placebo, either no difference or superiority was demonstrated in favour of asenapine on all efficacy measures. Conclusion: The current evidence is limited, as asenapine has been compared only with placebo or olanzapine. In the randomized clinical trials analysed, asenapine was similar or superior to placebo and similar or inferior to olanzapine on most efficacy outcomes. While asenapine demonstrated fewer adverse metabolic outcomes than olanzapine, rates of extrapyramidal symptom–related adverse effects were higher.

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