scholarly journals Adjunctive simvastatin treatment in schizophrenia patients; a double blind randomized and placebo controlled trial

2021 ◽  
Vol 7 (1) ◽  
pp. e02-e02
Author(s):  
Somaieh Ashrafi ◽  
Seyyed Mohammad Ghaffari ◽  
Hatam Boostani ◽  
Somaieh Raz ◽  
Negar Ebadi ◽  
...  
Keyword(s):  
Negative Symptoms ◽  
Mixed Model ◽  
Controlled Trial ◽  
Repeated Measure ◽  
Antipsychotic Treatment ◽  
Double Blind ◽  
Exact Test ◽  
Beneficial Effects ◽  
Significant Difference ◽  
Double Blinded

Introduction: Statins such as simvastatin are recently introduced as agents that may have beneficial effects in schizophrenia regarding their prominent anti-inflammatory properties. Objectives: This study was designed to evaluate the effects of simvastatin on schizophrenia symptoms. Patients and Methods: In a double-blinded randomized clinical trial, 40 hospitalized schizophrenia patients (according to the DSM-IV-TR criteria) were studied for 6 weeks. One group of the patients (n=20) received simvastatin (with the dose of 40 mg/d) and the other group received (n=20) placebo. The patients were evaluated by the Positive and Negative Syndrome Scale (PANSS) for schizophrenia symptoms. Data were analyzed with mixed model repeated measure ANOVA, t test, and χ2 test or Fischer’s exact test by SPSS software. The significant cutoff was considered at P<0.05. Results: The mean age of the patients was 34.05±9.74 years and 50% of them were men. There was not a significant difference between the two groups regarding negative symptoms reduction. Conclusion: Our study demonstrated that adding simvastatin on atypical antipsychotic treatment had no significant beneficial effects on the negative and positive symptoms in patients with schizophrenia disorder. Trial Registration: The trial protocol was approved by the Iranian Registry of Clinical Trials (identifier: IRCT2017052034046N1; https://en.irct.ir/trial/26134, ethical code; ETH-457).

N-acetyl-cysteine in a double-blind randomized placebo-controlled trial: Towards biomarker guided treatment in early psychosis

2017 ◽  
Vol 41 (S1) ◽  
pp. s806-s806
Author(s):  
P. Conus ◽  
M. Fournier ◽  
L. Xin ◽  
P. Baumann ◽  
C. Ferrari ◽  
...  
Keyword(s):  
Functional Outcome ◽  
Negative Symptoms ◽  
Controlled Trial ◽  
Early Psychosis ◽  
Antipsychotic Treatment ◽  
Positive Symptoms ◽  
Double Blind ◽  
Significant Difference ◽  
Oxidation Status ◽  
Acetyl Cysteine

PurposeRecent evidence points to a critical role of redox dysregulation induced oxidative stress in the pathophysiology of early phases of schizophrenia. An add-on trial with n-acetyl-cysteine (NAC) led to a reduction in negative symptoms in chronic schizophrenia patients. Aim of this study was to explore impact of addition of NAC to standard treatment in early psychosis (EP) patients.MethodsDouble-blind, randomized, placebo-controlled trial of addition of NAC, 2700 mg daily, to antipsychotic treatment over 6 months. Monthly assessment of PANSS, GAF, SOFAS and antipsychotics treatment; quantification of brain glutathione levels (GSHmPFC) by 1H-magnetic-resonance-spectroscopy and of blood cells glutathione (GSHBC) and glutathione peroxidase activity (GPxBC) as marker of oxidation status at the beginning and end of treatment.ResultsOverall, 63 patients were included. Spectroscopy data showed that GSHmPFC increased by +23% in the NAC group, while it tended to decrease by −5% in the placebo group (P = 0.005). No significant difference between NAC and placebo was observed on global changes in negative symptoms, positive symptoms or functional outcome. However, in patients with high-baseline oxidation status (GPxBC>22.3U/gHb), subgroup explorations revealed an improvement of positive symptoms over time compared to patients with low-baseline GPx (P = 0.02).ConclusionsWhile addition of NAC induced an increase of brain GSH, it had no impact on symptomatic and functional outcome in EP patients. However, in patients with high oxidation status, addition of NAC leads to significantly greater improvement in positive symptoms. Future studies on antioxidant interventions in EP should consider biomarker-guided treatment.Disclosure of interestThe authors have not supplied their declaration of competing interest.

A double-blind placebo-controlled trial of perioperative prophylactic antibiotics for elective neurosurgery

1988 ◽  
Vol 69 (5) ◽  
pp. 687-691 ◽  
Author(s):  
Ross Bullock ◽  
James R. van Dellen ◽  
William Ketelbey ◽  
S. Gustav Reinach
Keyword(s):  
Controlled Trial ◽  
Prophylactic Antibiotics ◽  
Risk Of Infection ◽  
Broad Spectrum Antibiotic ◽  
Wound Sepsis ◽  
Double Blind ◽  
Content Type ◽  
Exact Test ◽  
Significant Difference ◽  
To Receive

✓ In this study, 417 patients undergoing “clean” elective neurosurgical operative procedures were randomized to receive a broad-spectrum antibiotic (piperacillin) or placebo given as three perioperative doses, each 6 hours apart. Randomization was carried out by hospital pharmacists, and the investigators remained blinded until the end of the study. Twenty cases were excluded from analysis because either an unforeseen second operation was performed or antibiotic therapy was initiated within 30 days after surgery to treat infection or the risk of infection. Twelve of the 205 patients treated with placebo developed postoperative wound sepsis, and four of the 192 piperacillin-treated patients developed wound sepsis — a statistically significant difference (p < 0.05, Fisher's exact test). Piperacillin thus appeared to reduce the incidence of neurosurgical wound infection in this study.

Preliminary results of RTOG 0831, a randomized, double-blinded, placebo-controlled trial of tadalafil in the prevention of erectile dysfunction in patients treated with radiotherapy for prostate cancer.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 9525-9525
Author(s):  
Deborah Bruner ◽  
Stephanie L. Pugh ◽  
Thomas Michael Pisansky ◽  
Richard Evan Greenberg ◽  
Nadeem Pervez ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Erectile Function ◽  
Controlled Trial ◽  
First Year ◽  
Additional Time ◽  
Double Blind ◽  
Exact Test ◽  
Intent To Treat ◽  
Double Blinded ◽  
Penile Bulb

9525 Background: Determine if prophylactic tadalafil maintains spontaneous (off-drug) erectile function (EF) compared to placebo in patients (pts) treated with radiotherapy (RT) for prostate cancer. Methods: Double-blind 1:1 randomization to tadalafil 5mg daily for 6 mos vs placebo starting with RT. Primary outcomes measured by International Index of Erectile Function (IIEF). Eligibility included pre-RT IIEF Question [Q] 1 response “sometimes/most times/always” able to get an erection. Ps treated with hormones were excluded. Primary outcome was response to IIEF Q1 at 30 wks (6 wks off drug). Pts were stratified by RT modality (external vs. brachytherapy) and age (≤65 vs. >65 years). 182 pts were needed in an intent-to-treat analysis to show a difference from 20% responders with placebo to 40% with tadalafil based on a 2-sided Fishers exact test with α=0.05 and 80% power. Results: We report on 155/222 analyzable/eligible pts. Median age was 63 years, white (73%), and external RT (63%). Mean total dose for external RT was 77.23 Gy and 136.74 Gy for brachytherapy with penile bulb D50 of 24.46 Gy and 31.24 Gy respectively. Most pts completed treatment per protocol (84% tadalafil, 70% placebo). Spontaneous EF at 30 wks from drug start was not different (p=0.99) between arms based on IIEF Q1 response, total IIEF score (52.5 drug vs 52.8 placebo), or score change from baseline (-8.0 drug vs -8.8 placebo). No difference in these outcomes was noted at 1 year. Non-responders at 30 wks were likely to be older (age≥65; p=0.432), but there were no significant predictors at 1 year. About 80% of pts maintained spontaneous EF in both arms. Conclusions: Low-dose daily tadalafil did not preserve EF within the first year of RT for prostate cancer. If tadalafil positively influences delayed RT-induced vasogenic injury, additional time may be needed to observe a benefit to tadalafil as a preventive agent. Alternatively, tadalafil dose modification or altered dosing schedules may be needed to demonstrate a protective effect of this agent when used with RT. Clinical trial information: NCT00951184.

scholarly journals Comparison of Clinical Efficacy of Intravenous Acetaminophen with Intravenous Morphine in Acute Renal Colic: A Randomized, Double-Blind, Controlled Trial

2014 ◽  
Vol 2014 ◽  
pp. 1-5 ◽  
Author(s):  
Kambiz Masoumi ◽  
Arash Forouzan ◽  
Ali Asgari Darian ◽  
Maryam Feli ◽  
Hassan Barzegari ◽  
...  
Keyword(s):  
Clinical Efficacy ◽  
Renal Colic ◽  
Controlled Trial ◽  
Repeated Measure ◽  
Morphine Group ◽  
Double Blind ◽  
Significant Difference ◽  
Intravenous Acetaminophen ◽  
Acute Renal Colic ◽  
Intravenous Morphine

The aim of this study was to compare the clinical efficacy of intravenous acetaminophen with intravenous morphine in acute renal colic pain management. In this double-blind controlled trial, patients aged 18–55 years, diagnosed with acute renal colic, who met the inclusion and exclusion criteria, were randomized into two groups. First, using the visual analogue scale (VAS), intensity of pain was assessed in both groups. Then, one gram of intravenous acetaminophen or 0.1 mg/kg morphine was infused in 100 mL normal saline to either acetaminophen or morphine group. Intensity of pain was reassessed in 15, 30, 45, and 60 minutes according to VAS criteria. Finally, data from 108 patients were analyzed, 54 patients in each group. No significant difference was observed between the two groups in regard to sex (P=0.13), mean age (P=0.54), and baseline visual analogue score (P=0.21). A repeated measure analysis of variance revealed that the difference between the two treatments was significant (P=0.0001). The VAS reduction at primary endpoint (30 min after drug administration) was significantly higher in the acetaminophen group than in the morphine group (P=0.0001). This study demonstrated that intravenous acetaminophen could be more effective than intravenous morphine in acute renal colic patients’ pain relief.

scholarly journals The Effects of Quetiapine on Craving and Withdrawal Symptoms in Methamphetamine Abuse: A Randomized, Double-Blind, Placebo-Controlled Trial

2020 ◽  
Vol 10 (4) ◽  
pp. 29374.1-29374.7
Author(s):  
Najme Sadat Javdan ◽  
◽  
Amir Ghaderi ◽  
Hamid Reza Banafshe ◽  
◽  
...  
Keyword(s):  
Controlled Trial ◽  
Withdrawal Symptoms ◽  
Chi Square ◽  
Double Blind ◽  
Methamphetamine Abuse ◽  
Beneficial Effects ◽  
Amphetamine Withdrawal ◽  
Significant Difference ◽  
Chi Square Test ◽  
To Receive

Background: Patients with Methamphetamine Abuse (MA) are susceptible to many complications like craving, and withdrawal symptoms. These trials were designed to evaluate the effect of quetiapine administration on craving and withdrawal symptoms in MA abuse. Methods: This trial was conducted on 60 people with MA abuse to receive either 100 mg quetiapine (n=30), or placebo (n=30) every day for 2 months. The Desire for Drug Questionnaire (DDQ) and Amphetamine Withdrawal Questionnaire (AWQ) scores were evaluated at baseline and after 2 months’ intervention. For data analysis, t test, and the Chi-square test were applied in SPSS v. 18. Results: Quetiapine significantly decreased DDQ (P=0.002) and AWQ symptoms (P=0.001) compared to the placebo. Furthermore, there was a significant difference among groups in terms of the frequency of negative urine tests (P<0.001). Conclusion: This trial showed that administration of quetiapine supplements for 2 months in individuals with MA abuse had beneficial effects on craving and withdrawal syndrome.

Adjunctive Memantine in Clozapine-Treated Refractory Schizophrenia: An Open-Label One-Year Extension Study

2017 ◽  
Vol 41 (S1) ◽  
pp. S279-S280
Author(s):  
P. Schulte ◽  
S. Veerman ◽  
J.B. Deijen ◽  
L. De Haan
Keyword(s):  
Executive Function ◽  
Negative Symptoms ◽  
Controlled Trial ◽  
Extension Study ◽  
Favorable Effect ◽  
Long Term Effects ◽  
Open Label ◽  
Double Blind ◽  
Beneficial Effects ◽  
One Year

IntroductionIn a recent placebo-controlled, double blind crossover trial (n = 52), we found significant beneficial effects on memory (d = 0.30) and negative symptoms (d = 0.29) after 12 weeks memantine augmentation in patients with clozapine-refractory schizophrenia.AimsIn this open-label 1 year extension study, we report the long-term effects and tolerability of memantine add-on therapy to clozapine.MethodsCompleters of the first trial who experienced beneficial effects during 12 weeks of memantine treatment received memantine for one year. Primary endpoints were memory and executive function using the Cambridge neuropsychological test automated battery (CANTAB), the Positive and Negative Syndrome Scale (PANSS), and the Clinical Global Impression Severity Scale (CGI-S).ResultsOf 31 RCT completers who experienced beneficial effects from memantine, 24 received memantine for one year. The small improvement in memory found in the memantine condition in the placebo-controlled trial remained stable in the extension study. Executive function did not improve. After 26 weeks of memantine add-on therapy to clozapine, PANSS negative symptoms (r = 0.53), PANSS positive symptoms (r = 0.50), and PANSS total symptoms (r = 0.54) significantly improved. Even further significant improvement in all these measures was observed between 26 weeks and 52 weeks memantine, with effect sizes varying from 0.39 to 0.51. CGI-S showed a non-significant moderate improvement at 26 weeks (r = 0.36) and 52 weeks (r = 0.34). Memantine was well tolerated without serious adverse effects.ConclusionsIn the one-year extension phase, the favorable effect of adjunctive memantine on memory was sustained and we observed further improvement of positive, negative and overall symptoms of schizophrenia.Disclosure of interestP.F.J.S. reports personal fees from H. Lundbeck A/S, outside the submitted work and he is a board member of the Dutch Clozapine Collaboration Group. L.d.H., has received investigator-led research grants or recompense for presenting his research from Eli Lilly, Bristol-Myers Squibb, Janssen-Cilag and AstraZeneca.

scholarly journals Heterogeneity and efficacy of antipsychotic treatment for schizophrenia with or without treatment resistance: a meta-analysis

2019 ◽  
Vol 45 (4) ◽  
pp. 622-631 ◽  
Author(s):  
Yuya Mizuno ◽  
Robert A. McCutcheon ◽  
Stefan P. Brugger ◽  
Oliver D. Howes
Keyword(s):  
Negative Symptoms ◽  
Meta Analysis ◽  
Treatment Resistance ◽  
Study Groups ◽  
Antipsychotic Treatment ◽  
Double Blind ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Positive And Negative Symptoms ◽  
Relative Variability

AbstractTwo important clinical questions are whether there is a subtype of schizophrenia which responds differently to clozapine relative to other antipsychotics, and whether greater efficacy of clozapine is dependent on the degree of treatment-resistance. The authors address this by examining both variability and magnitude of response in patients treated with clozapine and other antipsychotics for both treatment-resistant schizophrenia (TRS) and non-resistant schizophrenia. Double-blind randomised controlled trials comparing clozapine with other antipsychotics in patients with schizophrenia were identified using five databases. Standard deviations and means of change in total, positive, and negative symptoms were extracted. Variability ratio (VR) and coefficient of variation ratio (CVR) were used to quantify relative variability in symptom change. Hedges’ g was used to quantify mean differences. Ten TRS studies (n = 822) and 29 non-TRS studies (n = 2566) were meta-analysed. Relative variability in change of total symptoms did not differ significantly between clozapine and other antipsychotics in TRS studies (VR = 1.84; 95%CI, 0.85–4.02). These findings were similar with CVR, and for positive and negative symptoms. Clozapine was superior to other antipsychotics in improving total symptoms in both TRS (g = 0.34; 95%CI, 0.13–0.56) and non-TRS (g = 0.20; 95%CI, 0.08–0.32) studies. Furthermore, clozapine was superior in improving positive symptoms in both study groups, but not for negative symptoms. Pooled effect sizes showed no significant difference between TRS and non-TRS studies. These findings do not support a subtype of schizophrenia which responds specifically to clozapine. Clozapine is more effective than other antipsychotics irrespective of treatment-resistance, arguing for its use more generally in schizophrenia. PROSPERO CRD42018086507

Adjunctive memantine in clozapine-treated refractory schizophrenia: an open-label 1-year extension study

2016 ◽  
Vol 47 (2) ◽  
pp. 363-375 ◽  
Author(s):  
S. R. T. Veerman ◽  
P. F. J. Schulte ◽  
J. B. Deijen ◽  
L. de Haan
Keyword(s):  
Executive Function ◽  
Negative Symptoms ◽  
Controlled Trial ◽  
Neuropsychological Test ◽  
Extension Study ◽  
Favourable Effect ◽  
Long Term Effects ◽  
Open Label ◽  
Double Blind ◽  
Beneficial Effects

BackgroundIn a recent placebo-controlled, double-blind crossover trial (n = 52), significant beneficial effects on memory (d = 0.30) and negative symptoms (d = 0.29) were found after 12 weeks of memantine augmentation in patients with clozapine-refractory schizophrenia. In this open-label 1-year extension study we report the long-term effects and tolerability of memantine add-on therapy to clozapine.MethodCompleters of the first trial who experienced beneficial effects during 12 weeks of memantine treatment received memantine for 1 year. Primary endpoints were memory and executive function using the Cambridge Neuropsychological Test Automated Battery, the Positive and Negative Syndrome Scale (PANSS), and the Clinical Global Impression Severity Scale (CGI-S).ResultsOf 31 randomized controlled trial completers who experienced beneficial effects from memantine, 24 received memantine for 1 year. The small improvement in memory found in the memantine condition in the placebo-controlled trial remained stable in the extension study. Executive function did not improve. After 26 weeks of memantine add-on therapy to clozapine, PANSS negative symptoms (r = 0.53), PANSS positive symptoms (r = 0.50) and PANSS total symptoms (r = 0.54) significantly improved. Even further significant improvement in all these measures was observed between 26 weeks and 52 weeks of memantine, with effect sizes varying from 0.39 to 0.51. CGI-S showed a non-significant moderate improvement at 26 weeks (r = 0.36) and 52 weeks (r = 0.34). Memantine was well tolerated without serious adverse effects.ConclusionsIn the 1-year extension phase the favourable effect of adjunctive memantine on memory was sustained and we observed further improvement of negative, positive and overall symptoms in patients with clozapine-treated refractory schizophrenia.

scholarly journals Casein Hydrolysate Containing Milk-Derived Peptides Improves Facial Pigmentation Independent of An Anti-Atherosclerosis Effect: A Randomized, Double-Blind, Placebo-Controlled Trial

2020 ◽  
Author(s):  
Michiya Igase ◽  
Yoko Okada ◽  
Keiji Igase ◽  
Masayuki Ochi ◽  
Sayaka Matsumoto ◽  
...  
Keyword(s):  
Placebo Group ◽  
Arterial Stiffness ◽  
Controlled Trial ◽  
Casein Hydrolysate ◽  
Advanced Glycation ◽  
Related Factors ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Beneficial Effects ◽  
Significant Difference

Casein hydrolysate improves arterial stiffness, as estimated by brachial ankle pulse wave velocity (baPWV), in untreated hypertensive subjects. Facial pigmentation is a useful biomarker for arterial stiffness. This trial evaluated whether casein hydrolysate improves facial pigmentation in association with changes in arterial stiffness. A randomized, double-blind, placebo-controlled trial was conducted in 80 non-hypertensive Japanese participants randomly assigned to receive either active tablets containing casein hydrolysate or placebo for 48 weeks. Facial pigmentation and baPWV were measured at baseline and at the end of the intervention. Other biochemical atherosclerosis-related parameters were also measured, including advanced glycation end products (AGEs). Changes in facial pigmentation showed a significant difference between the groups. Change in baPWV was significantly better in the active than in the placebo group. In contrast, no significant association was seen between changes in facial pigmentation and those in baPWV. Among other atherosclerosis-related factors, changes in advanced glycation products (AGEs) were significantly decreased in the active compared to the placebo group. Further, changes in facial pigmentation were positively correlated with those in AGEs. Changes in AGEs were independently associated with changes in facial pigmentation. Casein hydrolysate improves facial pigmentation in non-hypertensive participants. Casein hydrolysate may have beneficial effects on glycation stress.

Does soft tissue mobilization assist static stretching to improve hamstring flexibility? A randomized controlled trial

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Shibili Nuhmani
Keyword(s):  
Soft Tissue ◽  
Controlled Trial ◽  
Knee Extension ◽  
Repeated Measure ◽  
Control Group ◽  
Static Stretching ◽  
Significant Difference ◽  
Hamstring Flexibility ◽  
Soft Tissue Mobilization ◽  
Experimental Group

AbstractObjectivesObjective of the study is to investigate whether Soft tissue mobilization (STM) can assist with static stretching to improve hamstring flexibly.MethodsThe design of the study was repeated measure design. The study was conducted at the physical therapy laboratory of Jamia Hamdard University, New Delhi. Participants included 78 healthy males with hamstring tightness, randomly assigned to either the control group (static stretching) or the experimental group (STM and static stretching). The experimental group received five sets of four different STM techniques, followed by two sets of 30-s static stretches 3 days per week over the course of 12 weeks. The control group received 5 min of sham ultrasound with an inactive probe prior to static stretching. Active knee extension test (AKE) was the outcome measure.ResultsBoth groups showed significant improvement in AKE compared with the baseline measurements. With ingroup analysis showed a significant difference in AKE across all measured time periods (weeks 4, 8, and 12) with pre-test in both groups (p<0.05). No significant difference in AKE improvement was found between groups (p>0.05).ConclusionThe results of this study show that STM prior to static stretching does not significantly improve hamstring flexibility among healthy individuals. Although this study cannot be generalized, the results may be useful for evidence-based practice in the management of hamstring tightness.

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