scholarly journals Adjunctive sarcosine plus benzoate improved cognitive function in chronic schizophrenia patients with constant clinical symptoms: A randomised, double-blind, placebo-controlled trial

2015 ◽  
Vol 18 (5) ◽  
pp. 357-368 ◽  
Author(s):  
Chun-Yuan Lin ◽  
Sun-Yuan Liang ◽  
Yue-Cune Chang ◽  
Shuo-Yen Ting ◽  
Ching-Ling Kao ◽  
...  
Keyword(s):  
Cognitive Function ◽  
Clinical Symptoms ◽  
Controlled Trial ◽  
Chronic Schizophrenia ◽  
Double Blind ◽  
Double Blind Placebo

scholarly journals High-Dose Betahistine Improves Cognitive Function in Patients With Schizophrenia: A Randomized Double-Blind Placebo-Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Yongqian Wang ◽  
Xufeng Huang ◽  
Hongzhen Fan ◽  
Huimei An ◽  
Ting Ma ◽  
...  
Keyword(s):  
Cognitive Function ◽  
Clinical Symptoms ◽  
Psychiatric Symptoms ◽  
Controlled Trial ◽  
Visual Learning ◽  
Verbal Learning ◽  
High Dose ◽  
Chinese Han ◽  
Double Blind ◽  
Double Blind Placebo

Background: There is currently no effective treatment for cognitive impairment associated with schizophrenia (CIAS). Recent studies have shown that increased histamine levels in the brain may help to improve CIAS symptoms. Betahistine is an H1-receptor agonist and H3-receptor antagonist. This study evaluated the effect of high-dose betahistine on cognitive function as well as its safety in Chinese Han patients with schizophrenia.Methods: This randomized double-blind, placebo-controlled trial enrolled 89 patients with schizophrenia who were randomly administered betahistine (72 mg/d) or placebo for 12 weeks. At baseline and at 4, 8, and 12 weeks after commencing the intervention, we measured changes in cognitive function and clinical symptoms using the MATRICS Consensus Cognitive Battery (MCCB) and Positive and Negative Syndrome Scale (PANSS), respectively. Furthermore, we used the Treatment Emergent Symptom Scale (TESS) to assess the adverse effects of the patients' medications.Results: Compared to the placebo group, the betahistine group showed significant improvements in the MCCB composite score after 12 weeks of treatment (p = 0.003) as well as improvements in MCCB verbal learning (p = 0.02) and visual learning (p = 0.001) domain scores. However, there were no significant improvements in the PANSS total scores or subscores (p > 0.05). Generally, high-dose betahistine treatment was considered safe in patients with schizophrenia.Conclusions: Additional use of high-dose betahistine can effectively improve cognitive function but not psychiatric symptoms in patients with schizophrenia. Betahistine (72 mg/d) is well tolerated by Chinese Han patients with schizophrenia.Trial Registration:chictr.org.cn, identifier: ChiCTR1900021078. http://www.chictr.org.cn/edit.aspx?pid=35484&htm=4

scholarly journals Effect of Melatonin on Cognitive Function and Sleep in relation to Breast Cancer Surgery: A Randomized, Double-Blind, Placebo-Controlled Trial

2014 ◽  
Vol 2014 ◽  
pp. 1-9 ◽  
Author(s):  
Melissa Voigt Hansen ◽  
Michael Tvilling Madsen ◽  
Lærke Toftegård Andersen ◽  
Ida Hageman ◽  
Lars Simon Rasmussen ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Placebo Group ◽  
Cognitive Function ◽  
Cognitive Dysfunction ◽  
Controlled Trial ◽  
Dropout Rate ◽  
Sleep Efficiency ◽  
Mean Difference ◽  
Double Blind ◽  
Double Blind Placebo

Background.Sleep disturbances and cognitive dysfunction are common in patients with breast cancer. Disturbed sleep leads to poor cognitive performance and exogenous melatonin may improve sleep and attenuate cognitive dysfunction. We hypothesized that melatonin would improve sleep and cognitive function after surgery.Methods.This study reports secondary endpoints from a randomized, double-blind, placebo-controlled trial. Women, 30–75 years, were randomized to 6mg oral melatonin/placebo for 3 months. We assessed postoperative cognitive dysfunction (POCD) with a neuropsychological test battery, sleep with a diary, and sleep quality with VAS.Results. 54 patients were randomized to melatonin (n=28) or placebo (n=26); 11 withdrew (10 placebo, 1 melatonin,P=0.002). The incidence of POCD was 0% (0/20) [95% CI 0.0%; 16.8%] in the placebo group and 0% (0/26) [95% CI 0.0%; 13.2%] in the melatonin group 2 weeks postoperatively (P=1.00) and 6.3% (1/16) [95% CI 0.0%; 30.2%] in the placebo group and 0% (0/26) [95% CI 0.0%; 13.2%] in the melatonin group 12 weeks postoperatively (P=0.38). Sleep efficiency was significantly greater in the melatonin group; mean difference was 4.28% [95% CI 0.57; 7.82] (P=0.02). The total sleep period was significantly longer in the melatonin group; mean difference was 37.0 min [95% CI 3.6; 69.7] (P=0.03).Conclusion.Melatonin increased sleep efficiency and total sleep time but did not affect cognitive function. The dropout rate was significantly lower in the melatonin group. This trial is registered with Clinicaltrials.govNCT01355523.

scholarly journals The Impact of Ascidian (Halocynthia roretzi)-derived Plasmalogen on Cognitive Function in Healthy Humans: A Randomized, Double-blind, Placebo-controlled Trial

2020 ◽  
Vol 69 (12) ◽  
pp. 1597-1607
Author(s):  
Hirofumi Watanabe ◽  
Masaki Okawara ◽  
Yoshiharu Matahira ◽  
Takashi Mano ◽  
Tatsuya Wada ◽  
...  
Keyword(s):  
Cognitive Function ◽  
Controlled Trial ◽  
Halocynthia Roretzi ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Healthy Humans ◽  
The Impact

scholarly journals Efficacy and safety of tocilizumab in patients with refractory Takayasu arteritis: results from a randomised, double-blind, placebo-controlled, phase 3 trial in Japan (the TAKT study)

2017 ◽  
Vol 77 (3) ◽  
pp. 348-354 ◽  
Author(s):  
Yoshikazu Nakaoka ◽  
Mitsuaki Isobe ◽  
Syuji Takei ◽  
Yoshiya Tanaka ◽  
Tomonori Ishii ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Takayasu Arteritis ◽  
Clinical Symptoms ◽  
Controlled Trial ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Systemic Symptoms ◽  
Intent To Treat ◽  
Time To Relapse

ObjectiveTo investigate the efficacy and safety of the interleukin-6 receptor antibody tocilizumab in patients with Takayasu arteritis (TAK).MethodsPatients with TAK who had relapsed within the previous 12 weeks were induced into remission with oral glucocorticoid therapy. In this double-blind, placebo-controlled trial, patients were randomly assigned 1:1 to receive weekly tocilizumab 162 mg or placebo subcutaneously, and oral glucocorticoids were tapered 10 %/week from week 4 to a minimum of 0.1 mg/kg/day until 19 patients relapsed. The primary endpoint was time to relapse of TAK, defined as ≥2 of the following: objective systemic symptoms, subjective systemic symptoms, elevated inflammation markers, vascular signs and symptoms or ischaemic symptoms.ResultsThe intent-to-treat and safety populations included 18 tocilizumab-treated and 18 placebo-treated patients. The per-protocol set (PPS) included 16 tocilizumab-treated and 17 placebo-treated patients. HRs for time to relapse of TAK were 0.41 (95.41% CI 0.15 to 1.10; p=0.0596) in the intent-to-treat population (primary endpoint) based on relapse in eight tocilizumab-treated and 11 placebo-treated patients and 0.34 (95.41% CI 0.11 to 1.00; p=0.0345) in the PPS. The secondary endpoints, time to relapse assessed by Kerr’s definition and clinical symptoms only, were consistent with the primary endpoint. Serious adverse events were reported in one tocilizumab-treated and two placebo-treated patients. There were no serious infections and no deaths.ConclusionAlthough the primary endpoint was not met, the results suggest favour for tocilizumab over placebo for time to relapse of TAK without new safety concerns. Further investigation is warranted to confirm the efficacy of tocilizumab in patients with refractory TAK.Trial registration numberJapicCTI-142616.

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