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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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.CC BY · PubMed Central

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“Abbreviations ACTH: Adrenocorticotropic hormone; AFSP: American Foundation for Suicide Prevention; AUC: Area under the curve; BDI: Beck Depression Inventory; BOLD: Blood oxygen level-dependent; BT: Behavioral therapy; CBT: Cognitive behavioral therapy; CGI-I: Clinical Global Impression of Improvement; CGI-S: Clinical…”
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Electroencephalographic and perceptual asymmetry differences between responders and nonresponders to an SSRI antidepressant21Data from two treatment protocols were combined so as to yield sufficient samples of female and male fluoxetine responders and nonresponders. With the exception of the initial placebo period in one study, the treatment protocols were comparable in terms of both fluoxetine doses and the raters evaluating treatment response. Most importantly, the differences between fluoxetine responders and nonresponders reported for the total samples were also evident when only the data for the placebo-controlled protocol were analyzed; however, the larger total sample allowed us to also take patient gender into account.22The 18 healthy women were screened for psychopathology using a structured interview schedule and were excluded if they had a hearing loss, substance abuse, a history of head trauma, or other neurologic disorder. They did not differ significantly from the female patients in education (mean = 15.8, SD = 1.3) or handedness (LQ = 84.7, SD = 20.6), but they were somewhat younger than the female patients [mean age = 27.6, SD = 6.9;t(35) = 3.21,p = .001]. Age was not, however, related to perceptual asymmetry scores of either female patients (r = −.01, ns) or male patients (r = −.02, ns) on the fused words test. Nor was age significantly correlated with alpha asymmetry scores of female patients (r = −.09, ns) or male patients (r = .11, ns).
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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: 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
Pace, Thaddeus W W
Ritchie, James C
Craighead, W Edward
Mayberg, Helen S
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: gold
doi.org
Licence: cc-by
www.springer.com/tdm (unspecified)
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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