EMBARC
Establishing Moderators and Biosignatures of Antidepressant Response in Clinical Care (EMBARC)
US four-site placebo-controlled trial of sertraline in 309 adults with early-onset or recurrent major depression plus 40 healthy controls, with 3T structural, task and resting-state fMRI, diffusion and ASL MRI before and one week into treatment, shared through the NIMH Data Archive.
Overview
EMBARC is an NIMH-funded randomized clinical trial built to find clinical and biological markers that predict who improves on an antidepressant. Adults with major depressive disorder were randomized to sertraline or placebo for eight weeks; those who did not respond were switched under double blind to bupropion (after sertraline) or sertraline (after placebo) for eight more weeks. MRI, EEG, behavioral tasks and blood samples were collected before treatment and again after one week, so that both baseline predictors and early changes can be related to outcome. A small healthy control group was tested to measure test-retest reliability and comparability of the markers across sites. Data are held in NIMH Data Archive collection 2199.
Composition
The design paper reports 309 randomized participants with MDD, recruited from August 2011 to December 2015, and 40 healthy controls (10 per clinical site, 12 of whom were also tested at a second site). Patients were outpatients aged 18 to 65 with early-onset, chronic or recurrent MDD and no psychosis or bipolar disorder. Their mean age is 37.3 years and 57% are female. Clinical sites were UT Southwestern, Columbia University, Massachusetts General Hospital and the University of Michigan. The NDA collection shares 336 subjects, 330 of them with imaging data.
Acquisition
All four sites scanned on 3T systems. The protocol covers a 3D T1-weighted structural scan, an emotional conflict task and a reward task in fMRI, resting-state fMRI, pseudo-continuous arterial spin labeling and diffusion tensor imaging. Every sequence except DTI was repeated at week 1. At baseline, 305 patients had anatomical MRI, 300 fMRI and 230 DTI. Resting and evoked-potential EEG were recorded at the same visits.
Annotations
There are no image labels. Each subject carries a SCID diagnosis, treatment arm, repeated Hamilton depression ratings and many clinical scales, which define response and remission outcomes.
Known limitations
The sample is restricted to early-onset or recurrent, chronic MDD, which limits how well findings transfer to other patients. Scanner models differ between sites and vendors are not reported in the design paper. The NDA collection description still names the originally planned citalopram, bupropion and CBT arms with 675 patients, which does not match the trial as run.
Cohort
Aggregate numbers from the sources below. Bars are relative to the 349 subjects.
Modality
subjects
- MRI 330 95%
Contrast / sequence
subjects, values can overlap
- T1-weighted 345 99%
- BOLD fMRI 340 97%
- Diffusion-weighted 270 77%
Condition
subjects, values can overlap
- Major depressive disorder 309 89%
- Healthy control 40 11%
Country
subjects
- United States 349 100%
License and access
Our reading of the license, not legal advice. Before you use the data, read the original license and confirm that your use is allowed. We take no responsibility for how you use a dataset. Full disclaimer
A research proposal is reviewed and approved
NIMH Data Archive Data Use Terms and Conditions (Data Use Certification)
Terms every NIMH Data Archive data access request accepts. Data are for research, scholarship or teaching; they may only be shared with collaborators who hold their own access; re-identification is forbidden; each publication needs an NDA Study linked to the data and an acknowledgement; downloaded data must be deleted when the research ends or after the one-year access period.
EMBARC is NIMH Data Archive collection 2199. Access needs an approved NDA data access request; study-specific clauses of the permission group are not broken down here.
What you can do
- Not stated
- Not stated
- Not stated
- Conditional
- Conditional
What you can share
- No
- Conditional
- Share trained models Not stated
What you must do
- Yes
- Share alike No
- Yes
- Conditional
- Manuscript review No
- No
- Yes
- Yes
Limits
- Yes
- Location limits No
Citation
Trivedi MH, McGrath PJ, Fava M, Parsey RV, Kurian BT, Phillips ML, et al. Establishing moderators and biosignatures of antidepressant response in clinical care (EMBARC): Rationale and design. J Psychiatr Res 78:11-23 (2016). doi:10.1016/j.jpsychires.2016.03.001
All numbers
Every number on this page, as stored in stats.csv, with its source.
| Measure | Breakdown | Value | Source |
|---|---|---|---|
| Subjects | total sum of 309 randomized participants with MDD and 40 healthy controls; the NDA collection lists 336 shared subjects | 349 | trivedi2016 Baseline Characteristics |
| Subjects | condition=depression randomized participants with MDD (including 10 from the feasibility trial) | 309 | trivedi2016 Table 3 |
| Subjects | condition=healthy test-retest reliability sample of 10 per clinical site | 40 | trivedi2016 Healthy Control Sample |
| Subjects | country=US four US university sites | 349 | trivedi2016 Study Participants |
| Subjects | modality=MR subjects shared in the Imaging data structure | 330 | nda-collection-2199 Data Expected |
| Subjects | contrast=T1w anatomical MRI at baseline: 305 with MDD and 40 controls | 345 | trivedi2016 Table 5 |
| Subjects | contrast=bold fMRI at baseline: 300 with MDD and 40 controls; Table 5 lists 309 with MDD at week 1 | 340 | trivedi2016 Table 5 |
| Subjects | contrast=dwi DTI at baseline: 230 with MDD and 40 controls | 270 | trivedi2016 Table 5 |
| Subjects | condition=depression;contrast=T1w anatomical MRI at baseline; 272 at week 1 | 305 | trivedi2016 Table 5 |
| Subjects | condition=depression;contrast=bold fMRI at baseline; Table 5 lists 309 at week 1 | 300 | trivedi2016 Table 5 |
| Subjects | condition=depression;contrast=dwi DTI at baseline | 230 | trivedi2016 Table 5 |
| Subjects | condition=healthy;contrast=T1w baseline and week 1 | 40 | trivedi2016 Table 5 |
| Subjects | condition=healthy;contrast=bold baseline and week 1 | 40 | trivedi2016 Table 5 |
| Subjects | condition=healthy;contrast=dwi baseline only | 40 | trivedi2016 Table 5 |
| Mean age | condition=depression | 37.3 | trivedi2016 Table 3 |
| Age SD | condition=depression | 13.2 | trivedi2016 Table 3 |
Sources
The keys used in the table above.
- trivedi2016 Trivedi et al. 2016, EMBARC rationale and design, J Psychiatr Res (author manuscript PMC6100771) paper
- cherry2019 Cherry et al. 2019, Cerebral blood perfusion predicts response to sertraline versus placebo in EMBARC, eClinicalMedicine (PMC6543260) paper
- nda-collection-2199 NIMH Data Archive collection 2199 page (EMBARC), General and Data Expected tabs website