Magnetic resonance imaging of a randomized controlled trial investigating predictors of recovery following psychological treatment in adolescents with moderate to severe unipolar depression: study protocol for Magnetic Resonance-Improving Mood with Psychoanalytic and Cognitive Therapies (MR-IMPACT)

Creators: Hagan, Cindy C.; Graham, Julia M. E.; Widmer, Barry; Holt, Rosemary J.; Ooi, Cinly; van Nieuwenhuizen, Adrienne O.; Fonagy, Peter; Reynolds, Shirley; Target, Mary; Kelvin, Raphael; Wilkinson, Paul O.; Bullmore, Edward T.; Lennox, Belinda R.; Sahakian, Barbara J.; Goodyer, Ian; Suckling, John

Abstract

Background: Major depressive disorders (MDD) are a debilitating and pervasive group of mental illnesses afflicting many millions of people resulting in the loss of 110 million working days and more than 2,500 suicides per annum. Adolescent MDD patients attending NHS clinics show high rates of recurrence into adult life. A meta-analysis of recent research shows that psychological treatments are not as efficacious as previously thought. Modest treatment outcomes of approximately 65% of cases responding suggest that aetiological and clinical heterogeneity may hamper the better use of existing therapies and discovery of more effective treatments. Information with respect to optimal treatment choice for individuals is lacking, with no validated biomarkers to aid therapeutic decision-making. Methods/Design: Magnetic resonance-Improving Mood with Psychoanalytic and Cognitive Therapies, the MR-IMPACT study, plans to identify brain regions implicated in the pathophysiology of depressions and examine whether there are specific behavioural or neural markers predicting remission and/or subsequent relapse in a subsample of depressed adolescents recruited to the IMPACT randomised controlled trial (Registration # ISRCTN83033550). Discussion: MR-IMPACT is an investigative biomarker component of the IMPACT pragmatic effectiveness trial. The aim of this investigation is to identify neural markers and regional indicators of the pathophysiology of and treatment response for MDD in adolescents. We anticipate that these data may enable more targeted treatment delivery by identifying those patients who may be optimal candidates for therapeutic response. Trial registration: Adjunctive study to IMPACT trial (Current Controlled Trials: ISRCTN83033550).

Additional Information

© 2013 Hagan et al.; licensee BioMed Central Ltd. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Received: 19 September 2013. Accepted: 2 October 2013. Published: 5 October 2013. This study was funded by the Medial Research Council (grant: G0802226) and the Behavioural and Clinical Neuroscience Institute (BCNI) at the University of Cambridge. The BCNI is jointly funded by the Medical Research Council and the Wellcome Trust. Additional support was received from the National Institute for Health Research (NIHR) Cambridge Biomedical Research Centre. We graciously thank all subjects and their parents for participating in the study. We also thank the Cambridge and Peterborough Foundation NHS Trust, Child and Adolescent Mental Health Services that recruited patients for IMPACT, Mental Health Research Network, IMPACT research assistants, and IMPACT clinicians, as this study would not be possible without their consistent support and extraordinary efforts. Authors' contributions: CH wrote the manuscript and led the manuscript development. All authors edited the manuscript and approved the final version. CH is the Project Coordinator for the study. JS conceived the project, led the study development process and is Principal Investigator of the study. IG contributed to study development and is Chief Investigator of the IMPACT study. Competing interests: Professor Bullmore is a part-time employee of GlaxoSmith Kline. Professor Sahakian consults for Cambridge Cognition, Lundbeck and Servier. Professor Sahakian also holds a grant from Janssen/J&J and owns share options in Cambridge Cognition, LLP. Professors Fonagy, Goodyer, Reynolds, Target and Suckling, and Drs. Hagan, Holt, Kelvin, Lennox, Ooi and Wilkinson report no competing interests. Ms. Graham and van Nieuwenhuizen and Mr. Widmer similarly report no competing interests.

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