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

ABSTRACT: 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.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.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.

SUBMITTER: Dunlop BW

PROVIDER: S-EPMC3539869 | biostudies-literature | 2012 Jul

REPOSITORIES: biostudies-literature

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

Dunlop Boadie W BW Binder Elisabeth B EB Cubells Joseph F JF Goodman Mark M MM Kelley Mary E ME Kinkead Becky B Kutner Michael M Nemeroff Charles B CB Newport D Jeffrey DJ Owens Michael J MJ Pace Thaddeus W W TW Ritchie James C JC Rivera Vivianne Aponte VA Westen Drew D Craighead W Edward WE Mayberg Helen S HS

Trials 20120709

<h4>Background</h4>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, whi ...[more]

PMID: 22776534

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Project description:Approximately 50% of patients with major depressive disorder (MDD) do not respond optimally to antidepressant treatments. Given this is a large proportion of the patient population, pretreatment tests that predict which patients will respond to which types of treatment could save time, money and patient burden. Brain imaging offers a means to identify treatment predictors that are grounded in the neurobiology of the treatment and the pathophysiology of MDD.The international Study to Predict Optimized Treatment in Depression is a multi-center, parallel model, randomized clinical trial with an embedded imaging sub-study to identify such predictors. We focus on brain circuits implicated in major depressive disorder and its treatment. In the full trial, depressed participants are randomized to receive escitalopram, sertraline or venlafaxine-XR (open-label). They are assessed using standardized multiple clinical, cognitive-emotional behavioral, electroencephalographic and genetic measures at baseline and at eight weeks post-treatment. Overall, 2,016 depressed participants (18 to 65 years old) will enter the study, of whom a target of 10% will be recruited into the brain imaging sub-study (approximately 67 participants in each treatment arm) and 67 controls. The imaging sub-study is conducted at the University of Sydney and at Stanford University. Structural studies include high-resolution three-dimensional T1-weighted, diffusion tensor and T2/Proton Density scans. Functional studies include standardized functional magnetic resonance imaging (MRI) with three cognitive tasks (auditory oddball, a continuous performance task, and Go-NoGo) and two emotion tasks (unmasked conscious and masked non-conscious emotion processing tasks). After eight weeks of treatment, the functional MRI is repeated with the above tasks. We will establish the methods in the first 30 patients. Then we will identify predictors in the first half (n=102), test the findings in the second half, and then extend the analyses to the total sample.International Study to Predict Optimized Treatment--in Depression (iSPOT-D). ClinicalTrials.gov, NCT00693849.

Project description:Bipolar II disorder (BP-II) is associated with marked morbidity and mortality. Quetiapine, the treatment with greatest evidence for efficacy in BP-II depression, is associated with metabolic burden. Psychotherapy, a treatment with few side effects, has not been systematically evaluated in BP-II. This study compared psychotherapy plus placebo to psychotherapy plus pharmacotherapy as treatments for BP-II depression. From 2010 to 2015, unmedicated adults (n = 92) with DSM-IV-TR BP-II depression were randomly assigned to weekly sessions of Interpersonal and Social Rhythm Therapy (IPSRT) plus placebo or IPSRT plus quetiapine and followed for 20 weeks. For primary outcomes, IPSRT + quetiapine yielded significantly faster improvement on 17-item Hamilton Depression Rating Scale (F₁,₁₁₅.₄ = 3.924, P = .048) and greater improvement on Young Mania Rating Scale (F₅₈.₅ = 4.242, P = .044) scores. Both groups, however, improved significantly over time with comparable response rates (≥ 50% reduction in depression scores): 67.4% (62/92) in the entire sample, with no between-group differences. Those randomly assigned to their preferred treatment were 4.5 times more likely to respond (OR = 4.48, 95% CI = 1.20-16.77, P = .026). IPSRT + quetiapine assignment was associated with significantly higher body mass index over time (F₆₇.₉₆ = 6.671, P = .012) and rates of dry mouth (79% v. 58%; χ² = 4.0, P = .046) and a trend toward more complaints of oversedation (100% vs 92%; χ² = 3.4, P = .063). IPSRT plus quetiapine resulted in greater symptomatic improvement but also more side effects than IPSRT alone. A subset of participants improved with IPSRT alone, although absence of an inactive comparator limits interpretation of this finding. Receipt of preferred treatment was associated with better outcomes. Harms, benefits, and preferences should be considered when recommending treatments for BP-II depression. ClinicalTrials.gov identifier: NCT01133821.

Project description:IntroductionAmong randomised controlled trials for depressed adolescents, the extent of variation in how depressive symptom outcomes are defined is unknown. The variability in which potential predictors of these outcomes are tested is also unclear. This paper is a protocol describing the methods of a planned scoping review. The scoping review will examine and summarise how change in depressive symptoms have been described in RCT treatment studies to date. This review will report the measures used to describe change in depressive symptoms and whether the measure was used as a continuous or binary outcome or both. This review will describe how dichotomous outcome terms are defined to describe change in depression severity. This review will also examine predictors, moderators and mediators of change in depressive symptoms within RCTs.Methods and analysisIn this paper, we describe the protocol for our scoping review. Following the format outlined by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews, a research librarian will develop an operationalised search strategy, which we will apply to the MEDLINE, Embase, PsycINFO and Cumulative Index to Nursing and Allied Health Literature databases. We will search for papers from inception to 6 February 2020. A hand search for key citations will also be conducted. Investigator-raters will screen articles, first via the titles and abstracts and then through full-text reviews. We will include articles with randomised control design which assess the treatment of adolescents with major depressive disorder. We will systematically extract and synthesise prespecified data which includes: definition of depression used for participant inclusion, measures used to evaluate changes in depression, type of outcome used (continuous, binary or both), definitions of dichotomous terms to denote change in depression (eg, response, remission, recovery, etc) and reported predictors/moderators/mediators of change.Ethics and disseminationEthics approval is not required. Findings will be presented in journal publications and at conferences.

Project description:BACKGROUND:Depression is a widespread disorder with severe impacts for individuals and society, especially in its chronic form. Current treatment approaches for persistent depression have focused primarily on reducing negative affect and have paid little attention to promoting positive affect. Previous studies have shown that metta meditation increases positive affect in chronically depressed patients. Results from previous trials provide evidence for the efficacy of a stand-alone metta meditation group treatment in combination with mindfulness-based approaches. Further research is needed to better understand the implementation of meditation practice into everyday life. Therefore, mindfulness and metta meditation in a group setting are combined with individual cognitive behavioral therapy (CBT) into a new, low-intensity, cost-effective treatment ("MeCBT") for chronic depression. METHODS/DESIGN:In this single-center, randomized, observer-blinded, parallel-group clinical trial we will test the efficacy of MeCBT in reducing depression compared to a wait-list control condition. Forty-eight participants in a balanced design will be allocated randomly to a treatment group or a wait-list control group. Metta-based group meditation will be offered in eight weekly sessions and one additional half-day retreat. Subsequent individual CBT will be conducted in eight fortnightly sessions. Outcome measures will be assessed at four time points: before intervention (T0); after group meditation (T1); after individual CBT (T2); and, in the treated group only, at 6-month follow-up (T3). Changes in depressive symptoms (clinician rating), assessed with the Quick Inventory of Depressive Symptoms (QIDS-C) are the primary outcome. We expect a significant decline of depressive symptoms at T2 compared to the wait-list control group. Secondary outcome measures include self-rated depression, mindfulness, benevolence, rumination, emotion regulation, social connectedness, social functioning, as well as behavioral and cognitive avoidance. We will explore changes at T1 and T2 in all these secondary outcome variables. DISCUSSION:To our knowledge this is the first study to combine a group program focusing on Metta meditation with state-of-the art individual CBT specifically tailored to chronic depression. Implications for further refinement and examination of the treatment program are discussed. TRIAL REGISTRATION:ISRCTN, ISRCTN97264476. Registered 29 March 2018 (applied on 14 December 2017)-retrospectively registered.

Project description:BACKGROUND:In the absence of one intervention that can cure all patients with major depressive disorder (MDD), the leading cause of disability worldwide, increased attention has been focused on selecting the best treatment based on patient characteristics. Theory-driven hypotheses for selecting the best treatments have not yet been adequately investigated. The present study tested the a priory hypothesis that attachment orientations may determine whether patients benefit more from a treatment where alliance provides a facilitative environment for the treatment to work, as in the case of supportive-expressive psychotherapy, vs. where alliance is conceptualized as an active ingredient in itself, as in the case of supportive psychotherapy. METHOD/DESIGN:To test the hypothesis that attachment orientation moderates the effect of treatment condition on outcome, we conduct a randomized controlled trial (RCT). One hundred patients are randomized to 16 sessions of either supportive-expressive or supportive psychotherapy for MDD, conducted by experienced psychologists. The primary outcome is change in the Hamilton Rating Scale for Depression. Secondary outcome measures include self-reported depressive and other symptoms, psychological and interpersonal functioning, quality of life, and the presence of the diagnosis of depression. Additional measures include hormonal levels, motion synchrony, and acoustic attributes, performance on cognitive tasks, and narrative material (collected from the sessions and from interviews). DISCUSSION:The RCT will expand our understanding of how the outcome of treatment can be optimized by identifying the most promising role of alliance in treatment, based on patients' pre-treatment attachment orientation. Results will contribute to the ongoing theoretical debate concerning the differential efficacy of various psychotherapeutic approaches for patients with different attachment orientations. The RCT will also contribute to progress toward personalized treatment by informing therapists about which of two approaches are most effective with patients based on their attachment styles. TRIAL REGISTRATION:Clinicaltrials.gov Identifier: NCT02728557 submitted on the 15.3.16. FUNDING:The Israel Science Foundation. Trial status: Recruitment is ongoing.

Dataset Information

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

Publications

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

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