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Predictors of remission in depression to individual and combined treatments (PReDICT): study protocol for a randomized controlled trial
Open accessAbstract
BACKGROUND: Limited controlled data exist to guide treatment choices for clinicians caring for patients with major depressive disorder (MDD). Although many putative predictors of treatment response have been reported, most were identified through retrospective analyses of existing datasets and very few have been replicated in a manner that can impact clinical practice. One major confound in previous studies examining predictors of treatment response is the patient's treatment history, which may affect both the predictor of interest and treatment outcomes. Moreover, prior treatment history provides an important source of selection bias, thereby limiting generalizability. Consequently, we initiated a randomized clinical trial designed to identify factors that moderate response to three treatments for MDD among patients never treated previously for the condition. METHODS/DESIGN: Treatment-naïve adults aged 18 to 65 years with moderate-to-severe, non-psychotic MDD are randomized equally to one of three 12-week treatment arms: (1) cognitive behavior therapy (CBT, 16 sessions); (2) duloxetine (30-60 mg/d); or (3) escitalopram (10-20 mg/d). Prior to randomization, patients undergo multiple assessments, including resting state functional magnetic resonance imaging (fMRI), immune markers, DNA and gene expression products, and dexamethasone-corticotropin-releasing hormone (Dex/CRH) testing. Prior to or shortly after randomization, patients also complete a comprehensive personality assessment. Repeat assessment of the biological measures (fMRI, immune markers, and gene expression products) occurs at an early time-point in treatment, and upon completion of 12-week treatment, when a second Dex/CRH test is also conducted. Patients remitting by the end of this acute treatment phase are then eligible to enter a 21-month follow-up phase, with quarterly visits to monitor for recurrence. Non-remitters are offered augmentation treatment for a second 12-week course of treatment, during which they receive a combination of CBT and antidepressant medication. Predictors of the primary outcome, remission, will be identified for overall and treatment-specific effects, and a statistical model incorporating multiple predictors will be developed to predict outcomes. DISCUSSION: The PReDICT study's evaluation of biological, psychological, and clinical factors that may differentially impact treatment outcomes represents a sizeable step toward developing personalized treatments for MDD. Identified predictors should help guide the selection of initial treatments, and identify those patients most vulnerable to recurrence, who thus warrant maintenance or combination treatments to achieve and maintain wellness.
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“They identify where an individual lies along a continuum of risk for illness progression (of the depressive illness or its underlying pathophysiology) and extension (additional complications beyond the syndrome of depression) 484,485 (Figure 8) and aid in reviewing the person's needs for intervention, including early intervention.”
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Metadata
- Authors
- Dunlop, B. W., Binder, E. B., Cubells, J. F., Goodman, M. M., Kelley, M. E., Kinkead, B., Kutner, M., Nemeroff, C. B., Newport, D. J., Owens, M. J., Pace, T. W. W., Ritchie, J. C., Rivera, V. A., Westen, D., Craighead, W. E., & Mayberg, H. S.
- Affiliations
- Emory University (US)
- University of Miami (US)
- Corresponding author
- Dunlop, Boadie W
- ORCID
- Venue
- Trials
- Published
- 2012-07-09
- Volume
- 13
- Issue
- 1
- Pages
- 106-106
- ISSN
- 1745-6215 (ISSN-L)
- PMC
- PMC3539869
- OpenAlex
- W2140592967
- Cited by
- 136
- References
- 156
- Citations by year
- 2025: 8 · 2024: 10 · 2023: 15 · 2022: 12 · 2021: 9 · 2020: 18 · 2019: 12 · 2018: 10 · 2017: 8 · 2016: 9 · 2015: 5 · 2014: 7 · 2013: 10 · 2012: 2
- FWCI
- 5.60
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Trials (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- MPG.PuRe (Max Planck Society) (submittedVersion)
- Funders
- Eli Lilly and Company
- National Institutes of Health (5r01mh080880-05, UL1TR000454, RR0039, MH077083, RR025008, MH080880, RO1 MH080880)
- National Institute of Mental Health (K23MH086690, R01-MH080880, P50MH077083)
- National Center for Research Resources (UL1RR025008, RR025008, M01RR000039)
- National Center for Advancing Translational Sciences
- Topics
- Health Sciences › Medicine › Pharmacology (medical) › Treatment of Major Depression
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
- Social Sciences › Psychology › Clinical Psychology › Psychotherapy Techniques and Applications
- Keywords
- major depressive disorder, predictors of treatment response, remission, cognitive behavioral therapy, duloxetine, escitalopram, treatment-naive patients, treatment selection, personalized treatment, recurrence, dexamethasone/corticotropin-releasing hormone test, resting-state fMRI, immunological markers, gene expression, personality, combination therapy, antidepressant augmentation
- MeSH terms
- Duloxetine Hydrochloride, Adolescent, Adult, Aged, Antidepressive Agents, Brain, Major Depressive Disorder, Drug Therapy, Combination, Female, Genetic Testing, Humans, Magnetic Resonance Imaging, Male, Middle Aged, Personality, Predictive Value of Tests, Remission Induction, Research Design, Thiophenes, Citalopram, Biomarkers, Treatment Outcome, Antidepressive Agents, Second-Generation, Young Adult
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