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Cited by 136Treatment of Major DepressionAnxiety, Depression, Psychometrics, Treatment, Cognitive ProcessesPsychotherapy Techniques and Applications

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Predictors of remission in depression to individual and combined treatments (PReDICT): study protocol for a randomized controlled trial

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Dunlop, Boadie W, Binder, Elisabeth B, Cubells, Joseph F, Goodman, Mark M, Kelley, Mary E, Kinkead, Becky, Kutner, Michael, Nemeroff, Charles B, Newport, D Jeffrey, Owens, Michael J, Pace, Thaddeus W W, Ritchie, James C, Rivera, Vivianne Aponte, Westen, Drew, Craighead, W Edward, Mayberg, Helen S·2012·Trials
DOI 10.1186/1745-6215-13-106PMC PMC3539869
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Abstract

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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Crossref · 10.1186/1745-6215-13-106

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Figure 1 PReDICT study design.
Figure 1 PReDICT study design.CC BY · PubMed Central
Figure 2 Schedule of events for PReDICT study. NOTE: Remitters to the acute (monotherapy) treatment phase enter into the extension follow-up phase beginning at week 12. BDI, Beck Depression Inventory; CGI, Clinical Global Impression; CTQ, Childhood Trauma Questionnaire: Dex/CRH, Dexamethasone Corticotropin Releasing Hormone test; DHUS, Daily Hassles and Uplifts Scale; DNA, Deoxyribonucleic acid; EHEI, Early Home Environment Interview; HARS, Hamilton Anxiety Rating Scale; HDRS, Hamilton Depression Rating Scale; IPDE, International Personality Disorders Examination; LES, Life Experiences Survey; LIFE, Longitudinal Interview Follow-up Evaluation; MADRS, Montgomery Depression Rating Scale; MRI, Magnetic resonance imaging; mRNA, Messenger ribonucleic acid; PABS, Patient Attitudes and Beliefs Scale; PE, Physical Exam; QIDS, Quick Inventory of Depressive Symptoms; Q-LES-Q, Quality of Life Enjoyment and Satisfaction Questionnaire; SCID, Structured Clinical Interview for DSM-IV; SDS, Sheehan Disability Scale; SWAP, Shedler-Westen Assessment Procedure, 2nd Ed.
Figure 2 Schedule of events for PReDICT study. NOTE: Remitters to the acute (monotherapy) treatment phase enter into the extension follow-up phase beginning at week 12. BDI, Beck Depression Inventory; CGI, Clinical Global Impression; CTQ, Childhood Trauma Questionnaire: Dex/CRH, Dexamethasone Corticotropin Releasing Hormone test; DHUS, Daily Hassles and Uplifts Scale; DNA, Deoxyribonucleic acid; EHEI, Early Home Environment Interview; HARS, Hamilton Anxiety Rating Scale; HDRS, Hamilton Depression Rating Scale; IPDE, International Personality Disorders Examination; LES, Life Experiences Survey; LIFE, Longitudinal Interview Follow-up Evaluation; MADRS, Montgomery Depression Rating Scale; MRI, Magnetic resonance imaging; mRNA, Messenger ribonucleic acid; PABS, Patient Attitudes and Beliefs Scale; PE, Physical Exam; QIDS, Quick Inventory of Depressive Symptoms; Q-LES-Q, Quality of Life Enjoyment and Satisfaction Questionnaire; SCID, Structured Clinical Interview for DSM-IV; SDS, Sheehan Disability Scale; SWAP, Shedler-Westen Assessment Procedure, 2nd Ed.CC BY · PubMed Central

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Research works printed but not linked: 4

  1. National Committee for Quality Assurance: The State of Health Care Quality 2007. 2007, Washington, DC: National Committee for Quality Assurance, 20-21.
  2. First MB, Spitzer RL, Gibbon M, Williams JB: Structured Clinical Interview for DSM-IV Axis I Disorders-Patient Edition (SCID-I/P, Version 2.0). 1995, New York: Biometrics Research Department, New York State Psychiatric Institute
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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
Publisher
Springer Science and Business Media LLC
Published
2012-07-09
Volume
13
Issue
1
Pages
106-106
ISSN
1745-6215 (ISSN-L)
DOI
10.1186/1745-6215-13-106
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
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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