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  Citation statistics : Table of Contents
   2018| July-September  | Volume 3 | Issue 3  
    Online since August 27, 2018

 
 
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RESEARCH ARTICLES
The effect of moxibustion on brain functional connectivity and effective brain networks in patients with amnestic mild cognitive impairment: study protocol for a randomized controlled trial and preliminary results
Xin-Yan Jia, Xu Yuan, Xiao-Mei Zhou, Rui Jiao, Hong-Liang Xie, Dan Wang, Liang Yin, Ting-Ting Tan, Qi-Qi Liu, Shang-Jie Chen
July-September 2018, 3(3):112-119
DOI:10.4103/2542-3932.238437  
Background and objectives: Mild cognitive impairment (MCI) is an intermediate state between normal aging and dementia, and can be divided into amnestic and non-amnestic types. Patients with amnestic MCI present with memory impairments that are often considered as the early manifestation of Alzheimer’s disease. Patients with amnestic MCI are more likely to progress to Alzheimer’s disease than patients with non-amnestic MCI. The U.S. Food and Drug Administration has not yet approved any drug that can treat amnestic MCI. Moxibustion is a common noninvasive traditional oriental intervention, which uses mainly the heat generated by burning herbal preparations containing moxa and mugwort (Artemisia vulgaris) to simulate acupoints for alleviating the symptoms. To date, many clinical studies have investigated the clinical use of moxibustion to improve memory impairments of Alzheimer’s disease, but these have failed to make a distinction between amnestic and non-amnestic MCI. Therefore, this trial has been designed to assess the effectiveness of moxibustion on amnestic MCI using the Montreal Cognitive Assessment Scale. We will also assess the safety of moxibustion in healthy controls, and analyze the variation of brain functional connectivity and effective brain networks in patients with amnestic MCI undergoing moxibustion using function magnetic resonance imaging. Design: This is a prospective, single-center, randomized controlled clinical trial. Methods: This study will enroll 64 patients with amnestic MCI and 48 healthy controls at Baoan People’s Hospital, Shenzhen, China. The first 64 recruited patients with amnestic MCI will be randomly divided into moxibustion, placebo moxibustion, drug, and control groups (n = 16 per group). In the moxibustion group, patients will be given moxa-wool moxibustion for 12 consecutive weeks. The placebo moxibustion group will receive placebo moxibustion on the same acupoints. Patients in the drug group will be given oral administration of donepezil hydrochloride tablets, 5 mg daily, for 12 consecutive weeks. The control group will receive no intervention. Forty-eight healthy controls will also be randomly assigned into moxibustion, placebo moxibustion, and control groups (n = 16 per group). Interventions will be the same as those received by the patients with amnestic MCI. Evaluators will be blind to group allocation. Outcome measures and preliminary results: The primary outcome measure will be the improvement in cognitive function 12 months after treatment. Secondary outcome measures will be the scores on the Montreal Cognitive Assessment Scale, Clinical Dementia Rating Scale, Mini-Mental State Examination Scale, and Activity of Daily Living Scale before treatment, after 12 weeks of treatment, and 6 months after the end of treatment, as well as brain function analysis before treatment and after 12 weeks of treatment and adverse events during treatment and follow-up. A correlation analysis between cognitive function scores and brain function results will be performed. Results of our preliminary study involving 60 patients with amnestic MCI who experienced moxibustion or received no treatment showed that moxibustion on acupoints significantly improved cognitive ability and quality of sleep in patients relative to the baseline and compared with the control group. Moreover, the scores on attention and delayed recall in the moxibustion group after treatment were significantly higher than those at base line. In the control group the scores on visual space, execution, and delayed recall were significantly lower than those at baseline. These findings indicate that moxibustion improves patient’s attention and delayed recall. If not, visual space, execution, and delayed recall in MCI patients tend to be declined over time. No obvious adverse responses to moxibustion treatment occurred in the preliminary study. Discussion: This proposed trial has the potential to uncover that moxibustion will enhance cognitive-related brain function connections and effector brain networks, which is not yet known. If moxibustion is shown to be an effective and safe treatment strategy in patients with amnestic MCI, then this may pave the way for use of this treatment in clinic amnestic MCI. Ethics and dissemination: This study was approved by the Medical Ethics Committee of the Chinese Clinical Trial Registry (approval No. ChiECRCT-2017018) in October 2016, and registered on April 2017. The study was designed in June 2016. Patient recruitment was initialized in October 2016. Data analysis will be completed in December 2019. Results will be disseminated through publication in a peer-reviewed journal. Protocol version: 1.0. Trial registration: This trial was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR-POC-17011162).
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Differences in intestinal microflora and metabolites between patients with schizophrenia, depression, bipolar disorder, and healthy subjects: protocol for a case-control study
Yi-Huan Chen, Zheng-Wu Peng, Xuan Zhang, Jie Bai, Shou-Fen Yu, Xiao-Sa Li, Xiao-Ling Qiang, Ping Zhou, Hong He, Hua-Ning Wang
July-September 2018, 3(3):120-127
DOI:10.4103/2542-3932.238438  
Background and objectives: The human intestine contains a large amount of commensal bacteria. Under normal conditions, the intestinal microflora is stable, forms intestinal biological barriers, and promotes the growth and development of the organism. However, changes in the external environment can lead to disturbances in intestinal micro-organisms, causing host dysfunction and resulting in various types of disease. This study will investigate the role of intestinal microbes in the development of depression, bipolar disorder, and schizophrenia. Design: A case-control study. Methods: We recruited 50 patients with schizophrenia, 50 with depression, 50 with bipolar disorder, 50 with bipolar depressive episode, 50 with manic or hypomanic bipolar episode, and 50 age- and sex-matched healthy individuals who received physical examinations at the Department of Psychiatry of Xijing Hospital (China). Outcome measures: The primary outcome measure is the degree of change in fecal bacterial microflora after 3 months of pharmaceutical treatment. The secondary outcome measures are the type and content of small molecule metabolites in feces, the Hamilton Depression Scale score, the Young Mania Rating Scale score, the positive and negative syndrome scale score, and the Global Assessment of Functioning scale score before vs. after treatment. Discussion: The results of this study will reveal changes in intestinal microflora and metabolic patterns in patients with schizophrenia, depression, and bipolar disorder. These data may lead to biomarkers for disease diagnosis and provide new directions for investigation of possible mechanisms underlying the development of mental disorders. Ethics and dissemination: This study was approved by Medical Ethics Committee, Xijing Hospital, China (approval No. KY20172048-1). This study was disigned in May 2017, received ethical approval on September 6, 2017, and registered on October 18, 2017. Patient recuritement initiated in November 2017 and ended in February 2018. Genomics and metabolomics detection and data analysis initiated in March 2018 and will end in December 2018. Results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal. Trial data will be publicly accessible via ResMan. Trial registration: This trial was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR-ROC-17013029). Protocol version: 2.0.
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Mindfulness training programme for undergraduate and graduate students with depression, anxiety and stress symptoms: Study protocol for a randomized controlled trial
Alessandra Almeida Assumpcao, Carmem Beatriz Neufeld, Maycoln M Teodoro
July-September 2018, 3(3):89-96
DOI:10.4103/2542-3932.238434  
Background and objectives: High prevalence rates of depression, anxiety and stress symptoms in undergraduate and graduate students have been pointed out as a growing concern in the literature. The high indexes of these psychopathological symptoms are considered a serious health problem, since they imply losses in the institutional, social and family spheres. Research on mindfulness interventions has demonstrated positive results in treating these symptoms. The study aims to evaluate the efficacy of mindfulness training programme in the treatment of depression, anxiety and stress symptoms in undergraduate and graduate students. Design: This is a randomized parallel-design controlled trial. Methods: Undergraduate and graduate students from the Federal University of Minas Gerais with depressive, anxiety and stress symptoms will be randomized into control and training group (n = 24/group). Mindfulness training will take place in a weekly meeting within 6 weeks and will be in a group format constituted by 8-12 participants. Each meeting will take 90 minutes. The control group will also receive the intervention after 6 weeks in the wait list condition. Outcome measures: The primary outcomes are Beck Depression Inventory-II, Beck Anxiety Inventory, and Perceived Stress Scale scores. The secondary outcomes are Rosenberg Self-Esteem Scale, and 12-item Short-Form Health Survey scores. Discussion: This trial will evaluate the efficacy of mindfulness training programme for undergraduate and graduate students with depressive, anxious and stress symptoms. This will help to improve mental health and the quality of life, as well as reducing psychological and social burdens for this population. Ethics and dissemination: The study protocol was approved by the Ethics Committee of Federal University of Minas Gerais, in Belo Horizonte, Brazil on April 20th, 2017, approval number 2.025.573. The committee will audit the progression of the research. The investigation results will be disseminated on peer review scientific journals. Trial registration: This trial was registered in the Brazilian Clinical Trial Registry (http://www.ensaiosclinicos.gov.br) (registration No. RBR-4mmvpc) on July 21st, 2017.
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Efficacy of vestibular stimulation treatment in the depressive phase of bipolar disorder: study protocol for a randomized, double-blind, controlled trial
Ana Maria Soza, Sergio A Barroilhet, Paul A Vöhringer
July-September 2018, 3(3):97-101
DOI:10.4103/2542-3932.238435  
Background and objectives: Bipolar disorder (BD) is a neuropsychiatric disorder characterized by the oscillation of mood states between hypoactive/pessimistic (depressive phase) and hyperactive/optimistic states (manic/hypomanic phase). Previous studies evidenced that a particular technique of neuro-vestibular stimulation is an effective treatment for major depression. This study will investigate the efficacy of the said vestibular stimulation technique in the depressive phase of BD, and will compare it with sham vestibular stimulation. Design: A double-blind, randomized controlled study. Methods: One hundred and twenty patients with bipolar type I or II, currently undergoing a depressive phase, will be randomized into the experimental group (n = 60) or control group (n = 60), receiving three sessions of real/sham vestibular stimulation. Outcome measures: The primary outcome is the change in Montgomery Asberg Depression Rating Scale scores from baseline to post 4 and 12 weeks. The secondary outcome is the vestibular activity assessed at baseline, post 4 and 2 weeks. Discussion: Currently, no treatment has proved efficacy for bipolar depression. Studies have demonstrated that lateralized neuro-vestibular stimulation is an effective treatment for mayor depression but has not been studied in the depressive phase of bipolar disorder. This investigation will give the first evidence supporting or denying the use of vestibular stimulation treatment in BD depression. Ethics and dissemination: This study protocol was approved by the Ethics Committee of SSMO (Servicio de Salud Metropolitano Oriente) in Santiago, Chile (approval No. 08032016) on March 8, 2016. The results of the study will be published in scientific journals and other media. Trial registration: ClinicalTrials.gov Identifier: NCT02778256.
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Deep-brain magnetic stimulation as add-on treatment to lithium carbonate in the treatment of bipolar depression: study protocol for a randomized, double-blind, sham-controlled trial
Le Xiao, Gang Wang, Lei Feng
July-September 2018, 3(3):102-111
DOI:10.4103/2542-3932.238436  
Background and objectives: Bipolar disorder is a highly prevalent mental disorder. In clinical practice, mood stabilizers such as lithium carbonate are the conventional treatment for bipolar disorder. However, these drugs have slow onset of action and are not sufficiently effective in the acute phase. Deep-brain magnetic stimulation was hypothesized to have significant therapeutic effects in patients with major depressive disorder by entrainment of neural oscillations. In previous clinical trials, deep-brain magnetic stimulation showed good outcomes in the treatment of unipolar depression. However, randomized controlled trials that verify these results are lacking. Therefore, the current proposal intends to address this issue. Design: A single-center, randomized, double-blind, sham-controlled trial. Methods: Sixty patients aged 18–60 years who have been diagnosed with bipolar disorder at Beijing Anding Hospital, Capital Medical University of China, will be included and randomly divided into experimental and control groups (n = 30 per group). Patients in the experimental group will be treated with deep-brain magnetic stimulation plus lithium carbonate for 2 weeks followed by subsequent treatment with only lithium carbonate for 4 weeks. Patients in the control group will be treated with the same protocol, except they will receive sham stimulation. Outcome measures: The primary outcome measure is the change in score on the 17-Item Hamilton Rating Scale for Depression at weeks 2 and 6. The secondary outcome measures include response rate, complete remission rate (clinical cure rate), and changes in scores on the Hamilton Anxiety Rating Scale, 16-Item Quick Inventory of Depressive Symptomatology Self-Report, Generalized Anxiety Disorder-7, 9-Item Patient Health Questionnaire, Young Mania Rating Scale, Clinical Global Impression-Bipolar Disorder, and Montreal Cognitive Assessment at visit points relative to baseline scores. The safety evaluation indicators are the incidence of adverse events and the rate of manic switch. Discussion: The trial will verify the effectiveness of deep-brain magnetic stimulation with lithium carbonate in the treatment of bipolar disorder, providing evidence as to whether this combined therapy has the potential to be new alternative treatment for bipolar disorder. Ethics and dissemination: The trial was approved by the Ethics Committee of Beijing Anding Hospital, Capital Medical University in China (approval No. 201777FS-2) on October 27, 2017. Design of the trial was completed on June 28, 2017, and the trial registration was completed at the Chinese Clinical Trial Registry on November 10, 2017. Recruitment was initiated in January 2018 and it is expected to be completed in December 2018. Follow-up visit will end in June, 2019. Data analysis will be completed in December 2019. The results of the study will be disseminated through presentations at scientific meetings and/or in peer-reviewed publications. Anonymized trial data will be available indefinitely at www.figshare.com. Trial registration: The trial has been registered with the Chinese Clinical Trial Registry (Registration No. ChiCTR-INR-17013338) and the version number is 2.1.
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