Abstract:
BACKGROUND:Despite significant advancements in psychopharmacology, treating major depressive disorder (MDD) is still a challenge considering the efficacy, tolerability, safety, and economical costs of most antidepressant drugs. One approach that has been increasingly investigated is modulation of cortical activity with tools of non-invasive brain stimulation - such as transcranial magnetic stimulation and transcranial direct current stimulation (tDCS). Due to its profile, tDCS seems to be a safe and affordable approach. METHODS AND DESIGN:The SELECT TDCS trial aims to compare sertraline vs. tDCS in a double-blinded, randomized, factorial trial enrolling 120 participants to be allocated to four groups to receive sertraline+tDCS, sertraline, tDCS or placebo. Eligibility criteria are moderate-to-severe unipolar depression (Hamilton Depression Rating Scale >17) not currently on sertraline treatment. Treatment will last 6weeks and the primary outcome is depression change in the Montgomery-Asberg Depression Rating Score (MADRS). Potential biological markers that mediate response, such as BDNF serum levels, Val66Met BDNF polymorphism, and heart rate variability will also be examined. A neuropsychological battery with a focus on executive functioning will be administered. DISCUSSION:With this design we will be able to investigate whether tDCS is more effective than placebo in a sample of patients free of antidepressants and in addition, we will be able to secondarily compare the effect sizes of sertraline vs. tDCS and also the comparison between tDCS and combination of tDCS and sertraline.
journal_name
Contemp Clin Trialsjournal_title
Contemporary clinical trialsauthors
Brunoni AR,Valiengo L,Baccaro A,Zanao TA,de Oliveira JF,Vieira GP,Bueno VF,Goulart AC,Boggio PS,Lotufo PA,Bensenor IM,Fregni Fdoi
10.1016/j.cct.2010.09.007subject
Has Abstractpub_date
2011-01-01 00:00:00pages
90-8issue
1eissn
1551-7144issn
1559-2030pii
S1551-7144(10)00167-9journal_volume
32pub_type
杂志文章,随机对照试验abstract:OBJECTIVE:Our goal is to test the efficacy of a family-based, multi-component intervention focused on infants of African-American (AA) mothers and families, a minority population at elevated risk for pediatric obesity, versus a child safety attention-control group to promote healthy weight gain patterns during the firs...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2017.06.002
更新日期:2017-09-01 00:00:00
abstract:BACKGROUND:New approaches are needed to better monitor blood pressure (BP) between physician visits, especially for patients in rural areas or for those who lack transportation. We have developed a custom-built bi-directional texting platform for home BP measurements that can then be managed by clinical pharmacists loc...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2020.106169
更新日期:2020-11-01 00:00:00
abstract::Growing Right Onto Wellness (GROW) is a randomized controlled trial that tests the efficacy of a family-centered, community-based, behavioral intervention to prevent childhood obesity among preschool-aged children. Focusing on parent-child pairs, GROW utilizes a multi-level framework, which accounts for macro (i.e., b...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2013.08.013
更新日期:2013-11-01 00:00:00
abstract::The Medication Adherence and BP Control Trial (ABC Trial) is a randomized, controlled, multi-site, medication adherence and blood pressure (BP) control trial in an economically disadvantaged and multi-cultural population of hypertensive patients followed in primary care practices. To date, no other such trial has been...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.cct.2007.01.003
更新日期:2007-07-01 00:00:00
abstract:OBJECTIVES:Community Health Workers (CHWs) have been recommended to reduce diabetes disparities, but few robust trials of this approach have been conducted. Limitations of prior studies include: unspecified a priori outcomes; lack of blinded outcome assessments; high participant attrition rates; and lack of attention t...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2011.10.013
更新日期:2012-03-01 00:00:00
abstract:PURPOSE:African-American women (AAW) are more likely to be metabolically unhealthy than White women (WW). Metabolic syndrome (MetS) is associated with increased breast cancer risk and mortality from breast cancer is greater in AAW compared to WW. Data show MetS affects health-related quality of life (HRQoL). Exercise s...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2018.02.005
更新日期:2018-04-01 00:00:00
abstract::Despite strong anti-smoking efforts, at least 12% of American women cannot quit smoking when pregnant resulting in >450,000 smoke-exposed infants born yearly. Smoking during pregnancy is the largest preventable cause of childhood respiratory illness including wheezing and asthma. Recent studies have shown a protective...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2017.05.008
更新日期:2017-07-01 00:00:00
abstract:OBJECTIVE:Pregnancy of unknown location (PUL) is not a diagnosis but a transient state used to classify a woman when she has a positive pregnancy test without definitive evidence of an intra-uterine or extra-uterine pregnancy on transvaginal ultrasonography. Management of a persisting PUL varies substantially, includin...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2018.09.009
更新日期:2018-10-01 00:00:00
abstract:BACKGROUND:The Fontan circulation is a palliative procedure performed in patients with complex congenital heart disease (CHD), making transpulmonary blood flow dependent on the systemic venous pressure. In a Fontan circulation a low pulmonary vascular resistance (PVR) is crucial, as is epitomized by the observation tha...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.cct.2011.04.001
更新日期:2011-07-01 00:00:00
abstract:BACKGROUND:Chronic Obstructive Pulmonary Disease (COPD) frequently coexists with other diseases. Whereas COPD action plans are currently part of usual care, they are less suitable and potentially unsafe for use in the presence of comorbidities. This study evaluates whether an innovative treatment approach directed towa...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.cct.2013.06.003
更新日期:2013-09-01 00:00:00
abstract::Cancer related cognitive impairments (CRCI) are frequently reported by patients prior to, during and after medical treatment. Although this cognitive decline severely affects patients' quality of life, little is known about effective treatments. Exercise programs represent a promising supportive strategy in this field...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2016.05.007
更新日期:2016-07-01 00:00:00
abstract::The prevalence of type 2 diabetes continues to increase in minority and underserved patients, who are also more likely to have poorer control of diabetes and related risk factors for complications. Although the Look AHEAD trial has demonstrated improved risk factor control among overweight or obese diabetes patients w...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2016.12.005
更新日期:2017-02-01 00:00:00
abstract:BACKGROUND:Research demonstrates a link between migraine and obesity. Obesity increases the risk of frequent migraines and is associated with migraine prevalence among reproductive-aged women. These findings are substantiated by several plausible mechanisms and emerging evidence of migraine improvements after surgical ...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2013.03.004
更新日期:2013-05-01 00:00:00
abstract::College student alcohol use and associated negative consequences are clear public health problems with consequences including damage to self, others, and institutions. This paper describes the protocol of a research study designed to answer a number of important questions in the development of an adaptive preventive i...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2020.106089
更新日期:2020-09-01 00:00:00
abstract::In order to evaluate strategies to reduce HIV transmission through breast milk and optimize both maternal and infant health among HIV-infected women and their infants, we designed and implemented a large, randomized clinical trial in Lilongwe, Malawi. The development of protocols for large, randomized clinical trials ...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2008.09.001
更新日期:2009-01-01 00:00:00
abstract::Large, "practical" or streamlined trials (LSTs) are used to study the effectiveness and/or safety of medicines in real world settings with minimal study imposed interventions. While LSTs have benefits over traditional randomized clinical trials and observational studies, there are inherent challenges to their conduct....
journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.cct.2012.12.001
更新日期:2013-03-01 00:00:00
abstract::Major depressive disorder (MDD) is the most common mental illness and the leading cause of disability worldwide. Electroconvulsive therapy (ECT) is the most effective treatment for MDD and the gold-standard therapy for treatment-resistant depression (TRD), yet it remains underutilized due to factors such as limited av...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2018.12.009
更新日期:2019-02-01 00:00:00
abstract:BACKGROUND:There are numerous potential sources of problems when performing complex clinical research trials. These issues are compounded when studies are multi-site and multiple personnel from different sites are responsible for varying actions from case report form design to primary data collection and data entry. M...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2005.11.013
更新日期:2006-04-01 00:00:00
abstract:INTRODUCTION:Cognitive impairment (CI) and cardiovascular disease (CVD) disproportionately affect women compared to men, and CVD increases risk of CI. Physical activity and cognitive training can improve cognition in older adults and may have additive or synergistic effects. However, no combined intervention has target...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
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journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2018.03.002
更新日期:2018-05-01 00:00:00
abstract:INTRODUCTION:Focal ablation therapy is playing an increasing role in oncology and may reduce the toxicity of current surgical treatments while achieving adequate oncological benefit. Irreversible electroporation (IRE) has been proposed to be tissue-selective with potential advantages compared with current thermal-ablat...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2015.05.002
更新日期:2015-07-01 00:00:00
abstract::There is increasing evidence that exposure of developing brains in animals, including nonhuman primates, to commonly-utilized anesthetic agents may cause adverse effects on cognition and behavior. In this paper, we summarize our methodology for a population-based, propensity-matched study to evaluate possible anesthes...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2014.12.020
更新日期:2015-03-01 00:00:00
abstract:BACKGROUND:Persons with chronic obstructive pulmonary disease (COPD) have reduced exercise capacity and levels of physical activity. Supervised, facility-based pulmonary rehabilitation programs improve exercise capacity and reduce dyspnea, but novel long-term strategies are needed to maintain the benefits gained. Mind-...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2015.09.004
更新日期:2015-11-01 00:00:00
abstract::We developed a novel diagram to depict patient flow and outcomes in clinical trials. In contrast to flow diagrams such as the CONSORT chart, our diagram enables individual patient histories to be traced and depicts important patterns of treatment administration and outcomes, such as response and adverse events. Also, ...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2009.01.010
更新日期:2009-05-01 00:00:00
abstract:BACKGROUND:Postmenopausal Latinas are a growing population group in the US who are at high risk for cardiovascular disease. Epidemiological studies have shown that excessive sitting is related to cardiovascular disease risk. Older women sit for prolonged periods and most individuals do not meet physical activity guidel...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2019.02.004
更新日期:2019-04-01 00:00:00
abstract::This pilot study examined knowledge, understanding and perceived acceptability of key methodological concepts in clinical trials among injecting drug users (IDUs) in Sydney, Australia. Participants were clinical trial-experienced (n = 17) and trial-naïve (n = 99) IDUs recruited from community needle and syringe progra...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2009.04.002
更新日期:2009-09-01 00:00:00
abstract::This randomized, controlled trial tested the effectiveness of a nurse-run, telephone-based intervention to improve lipid control in patients with diabetes. Our patient population is predominantly low-income and Latino. Using our diabetes registry, we randomly assigned 381 patients to continue with their usual care and...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2008.05.011
更新日期:2008-09-01 00:00:00
abstract:BACKGROUND:Extant obesity efforts have had a limited impact among low-income underserved children, in part because existing programs are limited in terms of their short duration and low dosage, limited accessibility and sustainability; and failure to address barriers faced by diverse low-income families. METHODS:This ...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2018.12.010
更新日期:2019-02-01 00:00:00
abstract::Suicide remains the 10th leading cause of death among adults in the United States (U.S.). Annually, approximately 30 per 100,000 U.S. military Veterans commit suicide, compared to 14 per 100,000 U.S. civilians. Symptoms associated with suicidality can be treatment resistant and proven-effective pharmaceuticals may hav...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2016.02.002
更新日期:2016-03-01 00:00:00
abstract::Interactive voice response (IVR) technology is a robust method of data collection that has been underutilized in behavioral medicine and clinical pharmacotherapy research. While it is clear that there is an increasing interest in this technology, published research in the medical field has not described its implementa...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2007.02.007
更新日期:2007-09-01 00:00:00