Asia Pacific Journal of Clinical Trials: Nervous System Diseases最新文献

{"title":"Effect of transcranial direct current stimulation on the level of consciousness in patients with traumatic coma: study protocol for a self-controlled trial","authors":"Nilpadma Sarkar, S. Chatterjee, Ajay Gehlot","doi":"10.4103/2542-3932.257970","DOIUrl":"https://doi.org/10.4103/2542-3932.257970","url":null,"abstract":"Background and objectives: Traumatic brain injury patients suffer from coma, which leads to changes in behavior and consciousness. There is a paucity of available treatments which can improve the level of consciousness. Transcranial direct current stimulation (tDCS) is one of the non-invasive techniques to stimulate the motor cortex and improve the level of consciousness. The purpose of the study will be to assess the effect of tDCS on consciousness in patients with traumatic coma. Subjects and methods: The single-subject ABA design single-center study will be conducted in the Neuro-Surgery ICU, Maharishi Markandeshwar Hospital, India. Comatose patients associate with traumatic brain injury will be recruited. After baseline assessment all patients will get treatment with tDCS for 20 minutes twice a day for consecutive 5 days. Follow-up assessment will be taken on every first day of the consecutive 1st, 3rd and 5th weeks post-treatment. Ethical approval has been obtained from the Institutional Ethical Committee (IEC) of Maharishi Markandeshwar (Deemed to be University) (IEC/MMDU/2018/1183) on June 6, 2018. Outcome measures: JFK Coma Recovery Scale-Revised (CRS-R). Discussion: The study will investigate the possible effect of tDCS in improving level of consciousness in patients with traumatic brain injury. Trial registration: The study was registered with ctri.nic.in (CTRI/2019/01/017186) on January 22, 2019. It is the official website for registration of clinical trials in India regulated by Indian Council of Medical Research.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82718598","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy of entacapone and pramipexole in treating non-motor symptoms of Parkinson’s disease: a prospective randomized controlled trial","authors":"Zheng Bei, G. Wen, Yi Chen, Ning Bei","doi":"10.4103/2542-3932.257972","DOIUrl":"https://doi.org/10.4103/2542-3932.257972","url":null,"abstract":"Background and objective: Individuals with Parkinson’s disease exhibit a variety of non-motor symptoms that can negatively impact quality of life. Although both entacapone and pramipexole can be used to treat Parkinson’s disease via modulation of dopamine metabolism, the ways in which these treatments differ in terms of their effects on the non-motor symptoms of Parkinson’s disease are unknown. Participants and methods: This prospective, randomized, controlled trial will be conducted in the Geriatric Hospital of Hainan, Haikou, China. A total of 388 patients with idiopathic Parkinson’s disease will be randomly assigned to receive entacapone (n = 194) or pramipexole (n = 194). This study was approved by the Ethics Committee of the Geriatric Hospital of Hainan, China on August 30, 2013 (approval number: S2013-038-01) on August 30, 2013. Written informed consent regarding the study protocol and surgical procedure will be obtained from all participants. Results: The primary outcome measure will be the rate of improvement of non-motor symptoms 3 weeks after treatment. Secondary outcome measures will be soluble interleukin-2 receptor and homocysteine levels in serum, which reflect inflammation, and adverse events before and 3 weeks after treatment. Our self-controlled pilot study involving 100 patients showed that incidences of autonomic neurological symptoms such as postural hypotension, urinary urgency, urinary frequency, sexual dysfunction, dry mouth, and salivation, psychiatric symptoms such as cognitive dysfunction, hallucination, depression, and anxiety, and sensory abnormalities such as spasm, pain, and restless leg syndrome were remarkably reduced. Meanwhile, levels of serum soluble interleukin-2 receptor and homocysteine had noticeably decreased after treatment with entacapone and pramipexole. Conclusion: This trial will confirm the efficacy of entacapone and pramipexole in the treatment of non-motor symptoms of Parkinson’s disease. We hope that our findings will provide direction for future clinical treatment of non-motor symptoms of Parkinson’s disease, leading to improved patient quality of life. Trial registration: This study was registered with the Chinese Clinical Trial Registry on April 15, 2019 (registration number: ChiCTR1900022534). Protocol version is 1.0.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82063015","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Influence of bladder management on long-term quality of life in patients with neurogenic lower urinary tract dysfunction","authors":"J. Pannek, J. Krebs, J. Wöllner","doi":"10.4103/2542-3932.257969","DOIUrl":"https://doi.org/10.4103/2542-3932.257969","url":null,"abstract":"Background and objective: Patients with spinal cord injury suffer from neurogenic lower urinary tract dysfunction (NLUTD). NLUTD is associated with a considerable morbidity and mortality, but also affects the quality of life (QoL). We aimed to evaluate the longitudinal course of QoL in persons with NLUTD in relation to their bladder management. Subjects and methods: In a prospective self-controlled case series study. Patients with chronic NLUTD managing their bladder either by intermittent catheterization (n = 21), reflex voiding (n = 8), anterior root stimulation (n = 7), straining (n = 7) or suprapubic catheter (n = 4) were asked to fill in the Qualiveen® questionnaire at two time points with a time span of at least 1 year. Eleven patients were tetraplegic, and 36 persons suffered from paraplegia. The study was approved by the Ethics Committee of the Ethikkommission Nordwestund Zentralschweiz (approval No. PB_2016-02657) on September 24, 2007. Results: In total 47 patients returned both questionnaires and their data were therefore evaluated. The mean age at the first evaluation was 52 ± 12.8 years. The mean duration of NLUTD was 20.4 ± 12.3 years. A mean 2.4 ± 0.5 years had elapsed from the first to the second evaluation. None of the Qualiveen questionnaire domains showed a significant change between the two evaluation time points. The lesion level had a significant (P ≤ 0.023) effect on the domains constraints and QoL index. Conclusion: QoL in patients with chronic NLUTD seems to remain stable in long-term follow-up. Trial registration: ClinicalTrials.gov (NCT02179073) on July 1, 2014.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90895085","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of galvanic vestibular stimulation versus cervical proprioception training on pain, pressure pain sensitivity, and joint position sense in patients with chronic neck pain: study protocol for a randomized controlled trial","authors":"S. H. Fazeli, M. Akbari, I. Takamjani, Holakoo Mohsenifar, A. Jafarpisheh","doi":"10.4103/2542-3932.251478","DOIUrl":"https://doi.org/10.4103/2542-3932.251478","url":null,"abstract":"Background and objectives: Neck pain is a disabling condition associated with pain and proprioceptive disturbances. There is limited evidence on the efficacy of treatments for chronic neck pain (CNP). The aim of this study is to conduct a randomized, controlled trial to compare the effect of galvanic vestibular stimulation (GVS) with that of cervical proprioception training (CPT) on pain and proprioception acuity in patients with chronic neck pain. Subjects and methods: Forty-eight patients with CNP enrolled in this prospective, single-blind, randomized, controlled study will be randomly allocated to one of four groups: GVS, CPT, GVS + CPT, and control. The GVS group will receive galvanic stimulation, three sessions per week, for 6 weeks. The CPT group will perform proprioceptive exercises daily for 6 weeks. The GVS + CPT group will receive both interventions. The control group will have no intervention for 6 weeks, but 6 weeks later, they will receive physical therapy. In addition, 12 healthy subjects will be recruited. This study protocol has been approved by the Ethics Review Board of Iran University of Medical Sciences, with permission number IR.IUMS.REC 1395.9211342210 on August 8, 2016. Patient recruitment began in October 2016 and ended in October 2018. Data analysis will be performed in March 2019 and the study will be completed in May 2019. Outcome measures: The primary outcome measures will be intensity of pain, pressure pain threshold, and joint position error. The secondary outcome measures will be disability and health-related quality of life. Outcomes will be assessed at baseline and at the end of sessions 1 and 18. Discussion: Findings from the trial are expected to help assess the effectiveness of GVS, compared with CPT in patients with CNP. If this protocol is proven to be effective, it can be implemented in a clinical setting to manage chronic pain in patients with CNP. We expect this study to offer information about the positive effects of GVS and CPT. Findings from this study will be helpful in progressing GVS from science to practice and in managing disturbances in CNP. Trial registration: The study was registered at the Iranian Registry of Clinical Trials on September 26, 2016 (IRCT2016060121459N2).","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78928977","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Systemic lupus erythematosus is easily misdiagnosed as subacute combined degeneration","authors":"Hui Zhang, Yitao He, Yi Guo","doi":"10.4103/2542-3932.252278","DOIUrl":"https://doi.org/10.4103/2542-3932.252278","url":null,"abstract":"Background and objective: Systemic lupus erythematosus is likely the cause of neurological dysfunction manifested as subacute combined degeneration. The objective of this article is to report the clinical manifestation of systemic lupus erythematosus manifested as subacute combined degeneration. Methods: We retrospectively analyzed the clinical data of a 37-year-old female patient with systemic lupus erythematosus accompanied by subacute combined degeneration who received treatment at Shenzhen People's Hospital, China. This study met the requirements of the Declaration of Helsinki and the patient gave informed consent. Results: The patient initially presented the symptoms of numbness and weakness of both upper and lower limbs and urinary retention. The patient's physical signs involved peripheral nerve, and posterior and lateral columns of the spinal cord. Blood test revealed anemia and low folate level. Her clinical manifestation was consistent with subacute combined degeneration. But serum antinuclear antibodies (ANA), anti-double-stranded DNA (anti-dsDNA) antibodies, anti-Ro/Sjögren's antibodies (anti-Ro/SSA) and anti-La/Sjögren's antibodies (anti-La/SSB) were found to be positive. Finally, the diagnosis of systemic lupus erythematosus was considered. Conclusion: Systemic lupus erythematosus can cause a variety of neurological defect symptoms, especially in female patients. Tests for autoantibodies should be performed to reduce misdiagnosis rate.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79043666","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A reminder incentive system promotes the functional recovery of stroke patients with hemiplegia: A large-sample, single-blind, randomized controlled trial","authors":"Da-Hong Gao, Yuanfeng Peng, Bin Dong","doi":"10.4103/2542-3932.251476","DOIUrl":"https://doi.org/10.4103/2542-3932.251476","url":null,"abstract":"Background and objectives: Acupuncture and physical rehabilitation training have been shown to promote recovery in stroke patients with hemiplegia. Many patients are unable to consistently complete rehabilitation training because of a variety of factors. The aim of this study was to investigate the effects of wearing a wrist watch with versus without a rehabilitation training-reminder incentive system on locomotor function in stroke patients with hemiplegia. Participants and methods: This large-sample, single-blind, randomized controlled trial will be performed at the Second Affiliated Hospital of Anhui University of Chinese Medicine, Oxford International Rehabilitation Foundation Limited, and Oxford Brookes University. A total of 200 stroke patients with hemiplegia will be randomly divided into a test group and a control group. The two groups of patients will receive routine medication, acupuncture, and rehabilitation training. Patients in the test group will wear a smart watch with a reminder incentive system that encourages them to complete a set amount of personalized physical exercise tasks, and patients in the control group will wear a watch without a reminder incentive system. This study was approved by the Medical Ethics Committee of the Chinese Clinical Trial Registry on June 16, 2015 (approval No. ChiECRCT-20150034). Study protocol: 1.0. Participants will provide written informed consent. Results: The primary outcome measure of this study is the differences in the Barthel index measured 3 weeks after discharge (i.e., after 6 weeks of treatment). The secondary outcome measures include neurological deficit scores, National Institutes of Health stroke scale score, Rivermead mobility index, Montreal Cognitive Assessment score, blood pressure, body weight, grip strength, Timed Up and Go Test score, exercise level, EuroQol five dimensions questionnaire score, and adverse events before treatment, after 3 weeks of treatment, and 3 weeks after discharge (after 6 weeks of treatment). In a pilot study, 60 stroke patients with hemiplegia received acupuncture and incentive rehabilitation training. The results showed that in stroke patients with hemiplegia who received elongated needle acupuncture at antagonistic muscles combined with muscle balance exercises, Barthel index and Fugl-Meyer Assessment scale scores increased and Modified Ashworth Scale scores decreased compared with those who received elongated needle acupuncture at antagonistic muscles alone. Conclusion: We will perform a study involving 200 stroke patients to evaluate whether stroke patients with hemiplegia who receive acupuncture combined with rehabilitation training while wearing a smart watch with a reminder incentive system exhibit better recovery of locomotor function compared with those who receive similar interventions but are not exposed to a reminder incentive system. These experimental data will support the implementation of functional smart device-assisted rehabilitation me","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79139112","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A central pattern generator in the spinal cord for the central control of micturition: An opportunity for first-in-class drug treatments","authors":"P. Guertin","doi":"10.4103/2542-3932.251477","DOIUrl":"https://doi.org/10.4103/2542-3932.251477","url":null,"abstract":"For non-neuroscientists, the spinal cord is often considered simply as a relay between the brain and peripheral organs such as the skin, smooth muscles, and skeletal muscles. However, its gray matter has also been shown to play a pivotal role in the control of stereotyped motor behaviors. Neuroscientists have indeed clearly shown recently that the spinal cord contains command centers also known as central pattern generators. Those spinal centers have been found to elicit, inhibit or modulate locomotion, ejaculation, defecation and micturition. This short communication briefly outlines the main characteristics of the central pattern generator for micturition and how it could become a therapeutic target for innovative drugs against micturition-related problems.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83533684","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Serum levels of high-sensitivity C-reactive protein in acute ischemic stroke and its subtypes: a prospective case-control study","authors":"D. Rana, I. Anand, A. Batra, P. Sethi, S. Bhargava","doi":"10.4103/2542-3932.245216","DOIUrl":"https://doi.org/10.4103/2542-3932.245216","url":null,"abstract":"Background and objectives: Studies in different populations have shown that ischemic stroke can trigger an acute phase response resulting in a rise of plasma concentration of C-reactive protein (CRP) and high level of high-sensitivity CRP (hsCRP) is a risk factor for ischemic stroke. The objective of this study was to investigate the association of high hsCRP levels (≥ 1 mg/L) with ischemic stroke and its subtypes in Indian patients. Methods: This prospective observational case-control study included 150 patients (96 males, 54 females; aged 24–81 years) with first acute ischemic stroke who were admitted within 72 hours after onset, and 150 age- and sex-matched healthy controls. The study was conducted from July 2016 to July 2017. The patients were classified according to Trial of ORG 10172 in Acute Stroke Treatment classification. hsCRP levels were assessed in all included stroke patients. Results: The mean serum level of hsCRP was significantly higher in patients with first acute ischemic stroke than in healthy controls (P < 0.001). The mean serum level of hsCRP was higher in patients who had more severe stroke on admission. The prevalence of high serum level of hsCRP was highest in large-artery atherosclerosis (35.2%), followed by in cardioembolic (28.2%) stroke. The mean serum level of hsCRP was highest in large-artery atherosclerosis, followed by in stroke of undetermined etiology and cardioembolic subtype. High serum level of hsCRP was significantly associated with hypertension and age (P < 0.001 or P < 0.05). Multiple Logistic regression analysis revealed that high level of hsCRP was independently associated with acute ischemic stroke [odds ratio (OR) = 3.87, 95% confidence interval (CI): 2.39–6.27]. High hsCRP level was strongly associated with cardioembolic stroke (OR = 4.97, 95% CI: 2.5–9.65), large-artery atherosclerosis (OR = 4.75, 95% CI: 2.57–8.81), and stroke of undetermined etiology (OR = 3.36, 95% CI: 1.72–6.54). Conclusion: High hsCRP level is strongly associated with acute ischemic stroke and its subtypes, and it is an independent predictor of acute ischemic stroke. Ethics: The study was approved by the Sir Ganga Ram Hospital Ethics Committee (EC/07/14/701) on July 5, 2014.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84302550","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Do antipsychotic drugs improve working memory impairment caused by increased dopamine release during relapse phases of schizophrenia?","authors":"Ryota Ataniya","doi":"10.4103/2542-3932.245224","DOIUrl":"https://doi.org/10.4103/2542-3932.245224","url":null,"abstract":"This review summarizes the process by which working memory improves during the relapse phase of high dose antipsychotic therapy for schizophrenia, and presents a hypothesis as to why dopamine-related symptoms appear so strongly during the relapse phase with high dose antipsychotic therapy. Cognitive function related to dopamine in patients with schizophrenia varies depending on the levels of dopamine release and the dose of antipsychotics. Dopamine release is increased during the relapse phase in patients with schizophrenia. When high dose antipsychotic therapy is administered, working memory performance is low during the remission phase and increases during the relapse phase. Because the symptoms that are dependent on dopamine function are expected to show similar changes, we investigated the possibility that dopamine-related symptoms are not observed during the remission phase but may manifest during the relapse phase.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82832937","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cordyceps sinensis combined with duloxetine improves sleep symptoms in patients with depression: a randomized, double-blind, placebo-controlled study","authors":"Xu Chen, Xiaolong Zhang, Changming Wang, Lei Feng, G. Wang","doi":"10.4103/2542-3932.245217","DOIUrl":"https://doi.org/10.4103/2542-3932.245217","url":null,"abstract":"Background and objectives: Patients with depression can experience sleep disorder. Current treatments for depression, such as duloxetine and selective serotonin reuptake inhibitors, not only have a slow onset of action but also are associated with side effects such as dizziness, blurred vision, and ataxia. The main active ingredient of cordyceps sinensis, cordycepin, may have antidepressant effects, as well as pro-immunity, anti-inflammatory, anti-tumor, anti-fatigue, and anti-viral properties. In this randomized controlled trial, we investigate the safety and effectiveness of cordyceps sinensis (containing approximately 1.0% cordycepin) in combination with duloxetine in treating sleep disorder in patients with depression. Methods: In this randomized, double-blind, placebo-controlled, prospective trial, we plan to include 286 patients with depression receiving treatment at Beijing Anding Hospital of Capital Medical University, China. These patients are randomly assigned to undergo cordyceps sinensis combined with duloxetine or placebo combined with duloxetine. Duloxetine is assigned in an open manner, while cordyceps sinensis and placebo are assigned in a double-blind manner. Participants or their legal guardians are informed of the study protocol and medication and sign informed consent. A total of 246 patients were included in the polit study. Results: The primary outcome measure is the proportion of patients with ≥ 50% difference in 17-item-Hamilton Depression Rating Scale total score after 6 weeks of treatment relative to baseline. The secondary outcome measures are complete remission rate after 6 weeks of treatment; effectiveness rate after 1, 2, and 4 weeks of treatment; changes in Athens Insomnia Scale score, 17-item-Hamilton Depression Rating Scale total score, Arizona Sexual Experience Scale score, Mini-International Neuropsychiatric Interview suicide score, Digit Symbol Substitution Test score, Perceived Deficits Questionnaire-Depression score, 16-item Quick Inventory of Depressive Symptomatology Self-Report Scale score, 7-item Generalized Anxiety Disorder Scale score, and Sheehan Disability Scale score after 1, 2, 4, and 6 weeks of treatment relative to baseline; changes in Insight and Treatment Attitude Questionnaire score, and time and proportion of sleep drug use during the study period after 6 weeks of treatment relative to baseline; electroencephalogram results after 2 and 6 weeks of treatment; and blood biomarkers, safety indicators, and adverse events after 6 weeks of treatment. Results of a pilot study (during 2012–2016) involving 246 patients with depression receiving duloxetine 60 mg/d or fluoxetine 20 mg/d revealed that there was a similar percentage difference in 17-item-Hamilton Depression Rating Scale total score after 6 weeks of treatment relative to baseline and a similar incidence of drug use-related adverse events for both treatments. Discussion: We plan to perform a future study involving 286 patients to validate tha","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87542238","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}