Abstract:
UNLABELLED:Remission rates for Major Depressive Disorder (MDD) are low and unpredictable for any given antidepressant. No biological or clinical marker has demonstrated sufficient ability to match individuals to efficacious treatment. Biosignatures developed from the systematic exploration of multiple biological markers, which optimize treatment selection for individuals (moderators) and provide early indication of ultimate treatment response (mediators) are needed. The rationale and design of a multi-site, placebo-controlled randomized clinical trial of sertraline examining moderators and mediators of treatment response is described. The target sample is 300 participants with early onset (≤30 years) recurrent MDD. Non-responders to an 8-week trial are switched double blind to either bupropion (for sertraline non-responders) or sertraline (for placebo non-responders) for an additional 8 weeks. Clinical moderators include anxious depression, early trauma, gender, melancholic and atypical depression, anger attacks, Axis II disorder, hypersomnia/fatigue, and chronicity of depression. Biological moderator and mediators include cerebral cortical thickness, task-based fMRI (reward and emotion conflict), resting connectivity, diffusion tensor imaging (DTI), arterial spin labeling (ASL), electroencephalograpy (EEG), cortical evoked potentials, and behavioral/cognitive tasks evaluated at baseline and week 1, except DTI, assessed only at baseline. The study is designed to standardize assessment of biomarkers across multiple sites as well as institute replicable quality control methods, and to use advanced data analytic methods to integrate these markers. A Differential Depression Treatment Response Index (DTRI) will be developed. The data, including biological samples (DNA, RNA, and plasma collected before and during treatment), will become available in a public scientific repository. CLINICAL TRIAL REGISTRATION:Establishing Moderators and Biosignatures of Antidepressant Response for Clinical Care for Depression (EMBARC). Identifier: NCT01407094. URL: http://clinicaltrials.gov/show/NCT01407094.
journal_name
J Psychiatr Resjournal_title
Journal of psychiatric researchauthors
Trivedi MH,McGrath PJ,Fava M,Parsey RV,Kurian BT,Phillips ML,Oquendo MA,Bruder G,Pizzagalli D,Toups M,Cooper C,Adams P,Weyandt S,Morris DW,Grannemann BD,Ogden RT,Buckner R,McInnis M,Kraemer HC,Petkova E,Carmody TJdoi
10.1016/j.jpsychires.2016.03.001subject
Has Abstractpub_date
2016-07-01 00:00:00pages
11-23eissn
0022-3956issn
1879-1379pii
S0022-3956(16)30039-5journal_volume
78pub_type
杂志文章,多中心研究,随机对照试验abstract::Assuming that the experience of strong aversive tension might be an indicator of the extent of affect dysregulation within patients with borderline personality disorder (BPD), we sought to operationalize the duration and intensity of these phenomena. In addition we studied the relationship between aversive tension and...
journal_title:Journal of psychiatric research
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pub_type: 临床试验,杂志文章,多中心研究
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pub_type: 杂志文章
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journal_title:Journal of psychiatric research
pub_type: 杂志文章,随机对照试验
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