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Novel Augmentation Strategies in Major Depression Doctoral Dissertation Faculty of Health and Medical Sc ien ces University of Copenhagen Novel Augmentation Strategies in Major Depression Klaus Martiny Doctoral Dissertation Psychiatric Research Unit Psychiatric Centre North Zealand University of Copenhagen Cover: photo of dials and cogwheels from pocket watches illustrating “Depression - clocks out of synchrony”, by cour- tesy of Tilo Ahmels, Basel, Switzerland - original title “Zifferblätter”. ISBN 978-87-999299-0-0 1 Novel Augmentation Strategies in Major Depression Doctoral Dissertation Bright Light study Pindolol study PEMF study Chronos study Klaus Martiny Psychiatric Research Unit Psychiatric Centre North Zealand University of Copenhagen 2 Novel Augmentation Strategies in Major Depression Acceptance of dissertation: The Faculty of Health and Medical Sciences at the University of Copenhagen has accepted this dis- sertation, which consists of the already published dissertations listed below, for public defense for the doctoral degree in medicine. Copenhagen, 10th August 2016 Ulla Wewer Head of Faculty List of papers included in the thesis: • Martiny K, Lunde M, Undén M, Dam H, Bech P (2006). The lack of sustained effect of bright light, after discontinuation, in non-seasonal major depression. Psychol Med 36:1247-1252. • Martiny K, Lunde M, Undén M, Dam H, Bech P (2009). High cortisol awakening response is as- sociated with an impairment of the effect of bright light therapy. Acta Psychiatr Scand 120: 196-202. • Martiny K, Lunde M, Bech P, Plenge P (2012). A short-term double-blind randomized controlled pilot trial with active or placebo pindolol in patients treated with venlafaxine for major depres- sion. Nord J Psychiatry 66: 147-154. • Martiny K, Lunde M, Bech P (2010). Transcranial low voltage pulsed electromagnetic fields in patients with treatment-resistant depression. Biol Psychiatry 68: 163-169.* • Martiny K, Refsgaard E, Lund V, Lunde M, Sørensen L, Thougaard B, Lindberg L, Bech P (2012). A 9-week randomized trial comparing a chronotherapeutic intervention (wake and light thera- 3 py) to exercise in major depressive disorder patients treated with duloxetine. J Clin Psychiatry 73: 1234-1243.* • Martiny K, Refsgaard E, Lund V, Lunde M, Sørensen L, Thougaard B, Lindberg L, Bech P (2013). The day-to-day acute effect of wake therapy in patients with major depression using the HAM- D6 as primary outcome measure: results from a randomised controlled trial. PLoS One 28;8: e67264.* • Martiny K, Refsgaard E, Lund V, Lunde M, Thougaard B, Lindberg L, Bech P (2015). Maintained superiority of chronotherapeutics vs. exercise in a 20-week randomized follow-up trial in major depression. Acta Psychiatr Scand 131: 446-457. *Supplementary information accompanies the paper on the publisher’s website. None of the above papers or results herein has previously been submitted with the intension of acquiring an academic degree. Assessment committee: Professor emeritus Hans Ågren, University of Gothenburg Professor Raben Rosenberg, Psychiatric Center Amager, University of Copenhagen Professor Martin Balslev Jørgensen, Psychiatric Center Copenhagen, Rigshospitalet, University of Copenhagen (chair of the assessment committee) The defence takes place: Friday 4th of November 2016 at 14:30 in the Auditorium at Nordsjællands Hospital, entrance 50B, Helsevej, Hillerød. 4 Acknowledgements The four studies included in the present thesis were conducted during my appointments as a Ph.D. researcher from 2001-2004 and subsequently as a postdoctoral researcher from 2004-2010, at the Psychiatric Research Unit, Psychiatric Centre North Zealand. First of all I want to thank professor Per Bech for education in the noble art of research. To work with Per Bech, for so many years, has been a great inspiration, and he has offered ongoing support and guidance with a great enthusiasm in investigating new treatment methods and applications. Furthermore, in order of chronology, I wish to extend my gratitude to a number of scientific co- workers (research and project coordinators) at the Psychiatric Research Unit, Psychiatric Centre North Zealand. From Gabriele Bech-Andersen I have learnt a great many things concerning aca- demia and academic writing, and we have travelled the world and enjoyed many a scientific and humanistic discussion. Susan Søndergaard has kept a friendly critical eye on my English spelling and helped with manuscripts and studies. Marianne Lunde, who has contributed with a vast re- search expertise and specific knowledge of light therapy, was of great help in my bright light ther- apy study, the two papers of which are part of this thesis. Marianne was also pivotal in carrying out the Pindolol, the PEMF, and the Chronos studies. Her great charm has done much good in pa- tient handling and adherence. Lone Lindberg, who has assisted in managing the projects through- out, has encouraged me through difficult periods, and I am most grateful for her clever support. Else Refsgaard has been an absolutely invaluable help and inspiration in the Chronos study, work- ing with the project from the very beginning, throughout the whole process of study design, ap- provals, patient handling, and data management. This study, densely packed with scales and pro- cedures, would have been impossible to carry through without Else’s aid and help. Jim Bille with whom I have travelled to meetings around the world and who joined me in Milan to learn how to 5 perform wake therapy at the Hospital San Raffaele has been a wonderful support through all pro- jects. My dear colleague and friend Mogens Undén has been a faithful supporter throughout all studies. He is an early proponent for light therapy and one of the inventors of PEMF technology. Mogens is the most fearless and scientifically curious person I know – a true innovative research- er! I would like to thank physiotherapists Vibeke Lund, Lene Sørensen, and Britta Thougaard, for their enthusiastic effort in the Chronos study, teaching patients new skills and actually have them perform more than 30 minutes of exercise each day for 6 months! I would like to extend my gratitude to all the patients that participated in the four studies. The following external collaborators have been of great help and inspiration to me: I particular I want to thank Professor emeritus Anna Wirz-Justice for – at an early morning lecture on light therapy at the World Congress of Psychiatry in Hamburg in 1999 - inspiring me to start my own research into chronobiology. Anna has extended her colossal generosity, knowledge and networking capabilities to me ever since. I also wish to express my special thanks to Professor Mi- chael Terman and Jiuan Su Terman for ongoing guidance, friendship and hospitality in New York during my study visits there. I would also like to extend my gratitude to other researchers within the Society for Light Treatment and Biological Rhythms (SLTBR): Professor Francesco Benedetti, Professor Raymond Lam, Professor Joseph Wu, Professor Mirjam Münch, and Professor emeritus Daniel Kripke. Part of this group has met at different scientific meetings, often as presenters in symposia arranged by Anna Wirz-Justice and when preparing papers together. I owe a lot to the members of this group for ongoing support and guidance especially in connection with the Chronos study. 6 I would also like to thank Professor Lene Theil Skovgaard, Institute of Public Health, Panum Insti- tute, Copenhagen, for her ongoing statistical support. She has taught me the use of statistical tools that allow a clinically more meaningful and refined statistical analysis of data and with outstanding patience she endured my somewhat convoluted research questions. I would also like to thank Pro- fessor Dr.Sc. Steen Dissing, Department of Cellular and Molecular Medicine, University of Copen- hagen, one of the inventors of the PEMF technology, for convincing us, based on his own basic research, to go ahead with a clinical PEMF trial and for support during the study. I would like to thank Associate Professor MSc, DMSc Erling Mellerup and Associate professor MSc, DMSc Per- Plenge for prompting us to investigate pindolol as an augmenting agent and for support during the study. Professor Morten Møller , Department of Neuroscience and Pharmacology , University of Copenhagen kindly provided guidance on the topic of chronobiology in the early stages of the Chronos study. From my current workplace I would like to thank the following: Professor Anders Fink-Jensen was most helpful and understanding, allowing me to change to a different staff position and thus giving me appropriate time to complete my publications and write this thesis – for this I am very grateful. I also want to thank Head of Department Ida Hageman for giving me continued encouragement and for the warm interest in the research on light in psychia- try that we share. I would like to thank Professor Lars Vedel Kessing for welcoming me into the awe-inspiring research group at Department O in 2010 and for supporting my research efforts ever since. Lastly, I want to thank pioneer of light research in Denmark, Associate Professor Henrik Dam for sharing his experience with light therapy and for being a trustworthy colleague whom I have the privilege of working with at the Intensive Outpatient Unit for Affective Disorders. 7 Performing clinical studies is time-consuming and costly. I have been very fortunate that many foundations and agencies have contributed to the financing of my studies. I want to thank the fol- lowing parties in chronological order: The Bright Light study
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