scholarly journals Online Left-Hemispheric In-Phase Frontoparietal Theta tACS for the Treatment of Negative Symptoms of Schizophrenia

2021 ◽  
Vol 11 (11) ◽  
pp. 1114
Author(s):  
Chuan-Chia Chang ◽  
Cathy Chia-Yu Huang ◽  
Yong-An Chung ◽  
Jooyeon Jamie Im ◽  
Yen-Yue Lin ◽  
...  
Keyword(s):  
Large Scale ◽  
Negative Symptoms ◽  
Controlled Trial ◽  
Unmet Need ◽  
Subscale Score ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Neurocognitive Performance ◽  
Double Blind ◽  
Replication Studies

Negative symptoms represent an unmet need for schizophrenia treatment. The effect of theta frequency transcranial alternating current stimulation (theta-tACS) applied during working memory (WM) tasks on negative symptoms has not been demonstrated as of yet. We conducted a randomized, double-blind, sham-controlled trial of 36 stabilized schizophrenia patients, randomized to receive either twice daily, 6 Hz 2 mA, 20 min sessions of in-phase frontoparietal tACS or sham for five consecutive weekdays. Participants were concurrently engaged in WM tasks during stimulation. The primary outcome measure was the change over time in the Positive and Negative Syndrome Scale (PANSS) negative subscale score measured from baseline through to the 1-month follow-up. Secondary outcome measures were other symptom clusters, neurocognitive performance, and relevant outcomes. The intention-to-treat analysis demonstrated greater reductions in PANSS negative subscale scores at the end of stimulation in the active (−13.84%) than the sham (−3.78%) condition, with a large effect size (Cohen’s d = 0.96, p = 0.006). The positive effect endured for at least one month. Theta-tACS also showed efficacies for cognitive symptoms, WM capacity, and psychosocial functions. Online theta-tACS offers a novel approach to modulate frontoparietal networks to treat negative symptoms of schizophrenia. The promising results require large-scale replication studies in patients with predominantly negative symptoms.

scholarly journals Efficacy and Safety of Sipjeondaebo-Tang for Anorexia in Patients with Cancer: A Pilot, Randomized, Double-Blind, Placebo-Controlled Trial

2017 ◽  
Vol 2017 ◽  
pp. 1-9 ◽  
Author(s):  
Chunhoo Cheon ◽  
Jeong-Eun Yoo ◽  
Hwa-Seung Yoo ◽  
Chong-Kwan Cho ◽  
Sohyeon Kang ◽  
...  
Keyword(s):  
Placebo Group ◽  
Large Scale ◽  
Controlled Trial ◽  
Unmet Need ◽  
Double Blind ◽  
Patients With Cancer ◽  
Significant Difference ◽  
Cancer Anorexia

Background. Anorexia occurs in about half of cancer patients and is associated with high mortality rate. However, safe and long-term use of anorexia treatment is still an unmet need. Objective. The purpose of the present study was to examine the feasibility of Sipjeondaebo-tang (Juzen-taiho-to, Shi-Quan-Da-Bu-Tang) for cancer-related anorexia. Methods. A total of 32 participants with cancer anorexia were randomized to either Sipjeondaebo-tang group or placebo group. Participants were given 3 g of Sipjeondaebo-tang or placebo 3 times a day for 4 weeks. The primary outcome was a change in the Anorexia/Cachexia Subscale of Functional Assessment of Anorexia/Cachexia Therapy (FAACT). The secondary outcomes included Visual Analogue Scale (VAS) of anorexia, FAACT scale, and laboratory tests. Results. Anorexia and quality of life measured by FAACT and VAS were improved after 4 weeks of Sipjeondaebo-tang treatment. However, there was no significant difference between changes of Sipjeondaebo-tang group and placebo group. Conclusions. Sipjeondaebo-tang appears to have potential benefit for anorexia management in patients with cancer. Further large-scale studies are needed to ensure the efficacy. Trial Registration. This trial is registered with ClinicalTrials.gov NCT02468141.

A randomized, double-blind, placebo-controlled trial of memantine in a behaviorally enriched sample of patients with moderate-to-severe Alzheimer's disease

2013 ◽  
Vol 25 (6) ◽  
pp. 919-927 ◽  
Author(s):  
Nathan Herrmann ◽  
Serge Gauthier ◽  
Neli Boneva ◽  
Ole Michael Lemming
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Outcome Measures ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Neuropsychiatric Symptoms ◽  
Primary Outcome Measure ◽  
Community Dwelling ◽  
Secondary Outcome ◽  
Double Blind

ABSTRACTBackground: Agitation and aggression in Alzheimer's disease (AD) are amongst the most serious of neuropsychiatric symptoms, and contribute to poor outcomes and worse quality of life. Previous studies have suggested a benefit for memantine on agitation and aggression, but none have examined its efficacy in community-dwelling patients with significant agitation and aggression at baseline, utilizing these behaviors as a primary outcome measure.Methods: Patients with moderate-to-severe AD with Neuropsychiatric Inventory (NPI) total score ≥13 and NPI agitation/aggression score ≥1 were randomized to placebo or 20-mg memantine in a double-blind, 24-week trial. Co-primary outcome measures were behavior, measured by total NPI score, and cognition, using the Severe Impairment Battery (SIB). Secondary outcome measures included global assessment, function and other measures of behavior. This trial was registered as Clinicaltrials.gov: NCT00857649.Results: A total of 369 patients (average age = 75, average MMSE = 12) were randomized to placebo or memantine. The study was prematurely terminated due to recruitment problems. There were no statistically significant differences between memantine and placebo in mean change from baseline in NPI, SIB, or any of the secondary outcome measures. Behavior improved in both groups (total NPI change scores −3.90 ± 1.24 for memantine and −5.13 ± 1.23 for placebo). Memantine was generally well tolerated and patient retention in both treatment arms was good.Conclusions: The study failed to show the superiority of memantine in this sample of patients with moderate-to-severe AD with significant baseline agitation and aggression. Methodological limitations could have contributed to these results.

scholarly journals Assessing the effectiveness of perioperative s-ketamine on new-onset headache after resective epilepsy surgery (ESPAIN-trial): protocol for a randomised, double-blind, placebo-controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e030580
Author(s):  
Jiske Cornelia Theresa Sloekers ◽  
Michael Bos ◽  
Govert Hoogland ◽  
Caroline Bastiaenen ◽  
Sander van Kuijk ◽  
...  
Keyword(s):  
Human Subjects ◽  
Controlled Trial ◽  
Scientific Journal ◽  
Length Of Hospital Stay ◽  
Primary Outcome Measure ◽  
Temporal Lobectomy ◽  
Secondary Outcome ◽  
Drug Resistant ◽  
Double Blind ◽  
New Onset

IntroductionEffective treatment of new-onset headache after craniotomy, especially anterior temporal lobectomy (ATL) and amygdalohippocampectomy for drug-resistant temporal lobe epilepsy, is a challenge. The current practice, acetaminophen combined with opioids is often reported by patients as insufficient and sometimes accompanied by opioid-related adverse effects. Based on expert opinion, anaesthesiologists therefore frequently consider s-ketamine as add-on therapy. This randomised parallel group design trial compares s-ketamine with a placebo as add on medication to a multimodal pain approach.Methods and analysisIn total 62 adult participants, undergoing ATL for drug resistant epilepsy under general anaesthesia, will be randomised to either receive a 0.25 mg/kg bolus followed by a continuous infusion of 0.1 mg/kg/hour of s-ketamine or placebo (0.9% NaCl) starting before incision and continued for 48 hours as an addition to acetaminophen and opioids administered in a patient-controlled analgesia pump. The primary outcome measure is the cumulative postoperative opioid consumption. Patient recruitment started August 2018 and will end in 2021. Secondary outcome measures are postoperative pain intensity scores, psychological parameters, length of hospital stay and adverse events and will be reassessed at 3 and 6 months after surgery, with a baseline measurement preoperatively. All data are collected by researchers who are blinded to the treatment. The data will be analysed by multivariable linear mixed-effects regression.Ethics and disseminationEthical approval has been given by the local medical ethical committee (NL61666.068.17). This study will be conducted in accordance with the Dutch Medical Research Involving Human Subjects Act and the Declaration of Helsinki. The results of this trial will be publicly disclosed and submitted for publication in an international peer-reviewed scientific journal.Trial registration numberNTR6480.

scholarly journals Efficacy of Manual Acupuncture Versus Placebo Acupuncture for Generalized Anxiety Disorder (Gad) in Perimenopause Women : Study Protocol for a Randomized Controlled Trial

2021 ◽  
Author(s):  
Xin Liu ◽  
Xiaoyan Xie ◽  
Yingjia Li ◽  
Meichen Li ◽  
Yuting Wang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Anxiety Disorder ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Manual Acupuncture ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
Placebo Acupuncture

Abstract BackgroundGeneralized anxiety disorder (GAD) is common among perimenopause women. Drug treatment and cognitive behavioral therapy have their pros and cons. Acupuncture may be an effective treatment for GAD, but evidence is limited. The pathogenesis of GAD is not yet clear, but it is related to hypothalamic-pituitary-adrenal axis and its excretion, cortisol (CORT) and adrenocorticotropic hormone (ACTH). The object of this study is to assess the efficacy of manual acupuncture (MA) versus placebo acupuncture (PA) for perimenopause women with GAD. MethodsThis study is a single center, randomized, double blind clinical trial that will be conducted in the First Affiliated Hospital of Guangzhou University of Chinese Medicine. A total of 112 eligible GAD patients will be randomly assigned (1:1) to receive MA (n=56) or PA (n=56) three times per week for four weeks. The primary outcome measure will be the score of GAD-7. The secondary outcome measures will be the score of HAMA and PSQI, and the level of CORT and ACTH. The evaluation will execute at baseline, 2 weeks, the end of the treatment and a follow-up period. All main analyses will be carried out based on the intention-to-treat (ITT) principle. DiscussionThis study intends to conduct to compare the efficacy between MA and PA in the treatment of perimenopause woman with GAD, and to further study the mechanisms of effect. Trial registrationChinese Clinical Trial Registry, ID: ChiCTR2100046604. Registered on 22 May 2021. URL: http://www.chictr.org.cn.

scholarly journals Chinese Classical Prescription(Liang-Xue-Di-Huang Decoction)for Hemohhhoidal Disease:study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
qing zhou ◽  
Shuo-yang Shi ◽  
Zong-qi He ◽  
Cheng-biao Xu ◽  
Ji Geng ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Multicenter Trial ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Efficacy And Safety ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
Randomized Controlled ◽  
Objective Evidence ◽  
Bleeding Score

Abstract Background: Hemorrhoidal disease (HD) is one of the commonest proctologic condition in the general population. Medical therapy for HD has not been formally confirmed due to the inconsistent of results. Liang-Xue-Di-Huang Decoction, a kind of ancient Chinese classical prescription, has been used to treat HD from the 19th century in China. However, clinical research of Liang-Xue-Di-Huang Decoction in the treatment of HD is lack. We designed this study to evaluate the efficacy and safety of Liang-Xue-Di-Huang Decoction in the treatment of HD. Methods/Design: A randomized, controlled, double blind, double-mimetic agent and multicenter trial to evaluate the efficacy and safety of Liang-Xue-Di-Huang Decoction is proposed. HD patients (stage I, Ⅱ, Ⅲ) will be randomly assigned into Liang-Xue-Di-Huang Decoction with the addition of Diosmine mimetic agent, or Diosmine with the addition of Liang-Xue-Di-Huang Decoction mimetic agent. Patients will receive a 7-days treatments and a 7-days follow-up. The primary outcome measure is the French Bleeding Score in 7 and 14 days. The Secondary outcome measures are Goligher Prolapse Score and Quality-of-Life Score in 7 and 14 days. Discussion: This study will provide objective evidence to evaluate the efficacy and safety of Liang-Xue-Di-Huang Decoction in treatment of HD. Trial registration: Chinese Clinical Trial Registry. ChiCTR-1900022531.Registered 15 Apr 2019, http://www.chictr.org.cn/listbycreater.aspx.

scholarly journals Efficacy of Polygonatum sibiricum on Mild Insomnia: A Randomized Placebo-Controlled Trial

Nutrients ◽  
2019 ◽  
Vol 11 (8) ◽  
pp. 1719 ◽  
Author(s):  
Ha ◽  
Hong ◽  
Kim ◽  
Hong ◽  
Lee ◽  
...  
Keyword(s):  
Placebo Group ◽  
Sleep Quality ◽  
Controlled Trial ◽  
Sleep Time ◽  
Brain Regions ◽  
Primary Outcome Measure ◽  
Human Model ◽  
Secondary Outcome ◽  
Double Blind ◽  
Significant Group

Polygonatum sibiricum (PS) rhizome, which contains glyceryl-1-monolinoleate as its primary active component, has been shown to improve insomnia in animal models. Based on these findings, we aimed to investigate the safety and efficacy of PS rhizome extract in improving sleep quality in individuals with mild insomnia. Eighty individuals with mild insomnia were enrolled in a four-week, randomized, double-blind, placebo-controlled trial of PS rhizome extract (500 mg/day, n = 40, PS group) or placebo (n = 40, placebo group). The primary outcome measure was change in total score on the Athens Insomnia Scale (AIS) to indicate sleep quality. The secondary outcome measures included change in actigraphy data and perfusion levels in the brain regions within the default mode network (DMN), which is known to play a key role in insomnia. The PS group showed greater improvement in the total AIS score with a significant increase in total sleep time, relative to the placebo group. In addition, significant group-by-visit interactions were observed in the perfusion level of the medial prefrontal cortex within the DMN. Findings of the current study provide first evidence that PS rhizome extract could be an effective natural ingredient for improving sleep in mild insomnia using a human model.

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  > .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 < .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 Adjunctive Garcinia mangostana Linn. (Mangosteen) Pericarp for Schizophrenia: A 24-Week Double-blind, Randomized, Placebo Controlled Efficacy Trial: Péricarpe d’appoint Garcinia mangostana Linn (mangoustan) pour la schizophrénie : un essai d’efficacité de 24 semaines, à double insu, randomisé et contrôlé par placebo

2020 ◽  
pp. 070674372098243
Author(s):  
Alyna Turner ◽  
Andrea Baker ◽  
Olivia M. Dean ◽  
Adam J. Walker ◽  
Seetal Dodd ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Schizoaffective Disorder ◽  
Negative Symptoms ◽  
Controlled Trial ◽  
Safety Data ◽  
Rate Of Change ◽  
Adjunctive Treatment ◽  
Garcinia Mangostana ◽  
Double Blind

Objectives: Garcinia mangostana Linn. (“mangosteen”) pericarp contains bioactive compounds that may target biological pathways implicated in schizophrenia. We conducted a double-blind randomized placebo-controlled trial evaluating the efficacy of adjunctive mangosteen pericarp, compared to placebo, in the treatment of schizophrenia. Methods: People diagnosed with schizophrenia or schizoaffective disorder ( Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition), recruited across 2 sites (Brisbane and Victoria, Australia), were randomized to receive 24 weeks of adjunctive mangosteen pericarp (1,000 mg/day) or matched placebo. The primary outcome measure was the Positive and Negative Symptom Scale total score. Secondary outcomes included positive and negative symptoms, general psychopathology, clinical global severity and improvement, participant reported overall improvement, depressive symptoms, functioning, quality of life, and safety data at 24 and 28 weeks (4 weeks postdiscontinuation). Data were collected from July 2016 to February 2019. Results: Baseline assessments were conducted on 148 people (mangosteen = 74, placebo = 74); data analyses were conducted on 136 (92%) participants with postbaseline data. The treatment group had significantly higher symptom severity compared to placebo, and both groups significantly improved on all symptom, functioning, and quality of life measures over time. No between-group differences were found for the rate of change between baseline and 24 or 28 weeks. Conclusion: Despite promising preclinical and clinical work, our results do not support mangosteen pericarp extract as an adjunctive treatment for schizophrenia or schizoaffective disorder.

scholarly journals Randomized controlled trial of convalescent plasma therapy against standard therapy in patients with severe COVID-19 disease

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Manaf AlQahtani ◽  
Abdulkarim Abdulrahman ◽  
Abdulrahman Almadani ◽  
Salman Yousif Alali ◽  
Alaa Mahmood Al Zamrooni ◽  
...  
Keyword(s):  
Standard Therapy ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Severe Disease ◽  
Pilot Trial ◽  
Standard Of Care ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Open Label ◽  
Plasma Therapy

AbstractConvalescent plasma (CP) therapy in COVID-19 disease may improve clinical outcome in severe disease. This pilot study was undertaken to inform feasibility and safety of further definitive studies. This was a prospective, interventional and randomized open label pilot trial in patients with severe COVID-19. Twenty COVID-19 patients received two 200 ml transfusions of convalescent patient CP over 24-h compared with 20 who received standard of care. The primary outcome was the requirement for ventilation (non-invasive or mechanical ventilation). The secondary outcomes were biochemical parameters and mortality at 28 days. The CP group were a higher risk group with higher ferritin levels (p < 0.05) though respiratory indices did not differ. The primary outcome measure was required in 6 controls and 4 patients on CP (risk ratio 0.67, 95% CI 0.22–2.0, p = 0.72); mean time on ventilation (NIV or MV) did not differ. There were no differences in secondary measures at the end of the study. Two patients died in the control and one patient in the CP arm. There were no significant differences in the primary or secondary outcome measures between CP and standard therapy, although a larger definitive study is needed for confirmation. However, the study did show that CP therapy appears to be safe in hospitalized COVID-19 patients with hypoxia.Clinical trials registration NCT04356534: 22/04/2020.

scholarly journals Methotrimeprazine versus haloperidol in palliative care patients with cancer-related nausea: a randomised, double-blind controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e029942 ◽  
Author(s):  
Janet Rea Hardy ◽  
Helen Skerman ◽  
Jennifer Philip ◽  
Phillip Good ◽  
David C Currow ◽  
...  
Keyword(s):  
Palliative Care ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Response Rates ◽  
Complete Response ◽  
Response To Treatment ◽  
Secondary Outcome ◽  
Double Blind ◽  
Intention To Treat ◽  
Point Reduction

ObjectivesMethotrimeprazine is commonly used for the management of nausea but never tested formally against other drugs used in this setting. The aim was to demonstrate superior antiemetic efficacy.DesignDouble-blind, randomised, controlled trial of methotrimeprazine versus haloperidol.Setting11 palliative care sites in Australia.ParticipantsParticipants were >18 years, had cancer, an average nausea score of ≥3/10 and able to tolerate oral medications. Ineligible patients had acute nausea related to treatment, nausea for which a specific antiemetic was indicated, were about to undergo a procedure or had received either of the study drugs or a change in glucocorticoid dose within the previous 48 hours.InterventionsBased on previous studies, haloperidol was used as the control. Participants were randomised to encapsulated methotrimeprazine 6·25 mg or haloperidol 1·5 mg one time or two times per day and assessed every 24 hours for 72 hours.Main outcome measuresA ≥two-point reduction in nausea score at 72 hours from baseline. Secondary outcome measures were as follows: complete response at 72 hours (end nausea score less than 3), response at 24 and 48 hours, vomiting episodes, use of rescue antiemetics, harms and global impression of change.ResultsResponse to treatment at 72 hours was 75% (44/59) in the haloperidol (H) arm and 63% (36/57) in the methotrimeprazine (M) arm with no difference between groups (intention-to-treat analysis). Complete response rates were 56% (H) and 51% (M). In theper protocolanalysis, there was no difference in response rates: (85% (44/52) (H) and 74% (36/49) (M). Completeper protocolresponse rates were 64% (H) and 59% (M). Toxicity worse than baseline was minimal with a trend towards greater sedation in the methotrimeprazine arm.ConclusionThis study did not demonstrate any difference in response rate between methotrimeprazine and haloperidol in the control of nausea.Trial registration numberACTRN 12615000177550.

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