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Thesis May Be Reproduced, Distributed, Stored in a Retrieval System, Or Transmitted in Any Form Or by Any Means, Without Prior Written Permission of the Author UvA-DARE (Digital Academic Repository) Drug treatment for patients with acute mania: Understanding clinical trials and treatment success Welten, C.C.M. Publication date 2016 Document Version Final published version Link to publication Citation for published version (APA): Welten, C. C. M. (2016). Drug treatment for patients with acute mania: Understanding clinical trials and treatment success. General rights It is not permitted to download or to forward/distribute the text or part of it without the consent of the author(s) and/or copyright holder(s), other than for strictly personal, individual use, unless the work is under an open content license (like Creative Commons). Disclaimer/Complaints regulations If you believe that digital publication of certain material infringes any of your rights or (privacy) interests, please let the Library know, stating your reasons. In case of a legitimate complaint, the Library will make the material inaccessible and/or remove it from the website. Please Ask the Library: https://uba.uva.nl/en/contact, or a letter to: Library of the University of Amsterdam, Secretariat, Singel 425, 1012 WP Amsterdam, The Netherlands. You will be contacted as soon as possible. UvA-DARE is a service provided by the library of the University of Amsterdam (https://dare.uva.nl) Download date:05 Oct 2021 DRUG TREATMENT FOR PATIENTS WITH ACUTE MANIA Understanding clinical trials and treatment success Carlijn C.M. Welten Cover and layout design by The Fat Moose, www.thefatmoose.nl Printing by Uitgeverij BOXPress | Proefschriftmaken.nl ISBN: 978-94-6295-297-3 Author: Carlijn Welten All rights reserved. No part of this thesis may be reproduced, distributed, stored in a retrieval system, or transmitted in any form or by any means, without prior written permission of the author. ©2016 Carlijn Welten DRUG TREATMENT FOR PATIENTS WITH ACUTE MANIA - Understanding clinical trials and treatment success - ACADEMISCH PROEFSCHRIFT ter verkrijging van de graad van doctor aan de Universiteit van Amsterdam op gezag van de Rector Magnificus prof. dr. D.C. van den Boom ten overstaan van een door het College voor Promoties ingestelde commissie, in het openbaar te verdedigen in de Agnietenkapel op 15 januari 2016, te 10.00 uur door Carolina Cecilia Maria Welten geboren te Utrecht Promotores prof. dr. D.A.J.P. Denys Universiteit van Amsterdam prof. dr. H.G.M. Leufkens Universiteit Utrecht Copromotores dr. M.W.J. Koeter Universiteit van Amsterdam dr. T.D. Wohlfarth College ter Beoordeling van Geneesmiddelen Overige leden prof. dr. L. de Haan Universiteit van Amsterdam prof. dr. J.A. Swinkels Universiteit van Amsterdam prof. dr. E.M. Derks Universiteit van Amsterdam dr. N.C.C. Vulink Academisch Medisch Centrum prof. dr. A.W. Hoes Universiteit Utrecht prof. dr. R.W. Kupka Vrije Universiteit Amsterdam prof. dr. D. Deforce Universiteit Gent Faculteit der Geneeskunde “No amount of love can cure madness or unblacken one’s dark moods. Love can help, it can make the pain more tolerable, but, always, one is beholden to medication that may or may not always work and may or may not be bearable” - Kay Redfield Jamison, An Unquiet Mind: A Memoir of Moods and Madness, 1995 - CONTENTS Part I General introduction Chapter 1: General introduction 13 Part II Regulatory questions Chapter 2: Efficacy of drug treatment for acute mania differs 27 across geographic regions Chapter 3: Placebo response in antipsychotic trials of patients 45 with acute mania Chapter 4: Net gain analysis, an addition to responder analysis 63 Part III Clinical questions Chapter 5: Does insight affect the efficacy of antipsychotics in 83 acute mania? Chapter 6: Early non-response in the antipsychotic treatment of 99 acute mania; a criterion for reconsidering treatment? Part IV Summary and discussion Chapter 7: Summary and discussion 121 Part V Appendix Nederlandse samenvatting 145 Dankwoord 155 Portfolio 163 About the author 169 Contents | 9 PARTintroduction 1General 01 CHAPTER 1: GENERAL INTRODUCTION INTRODUCTION This thesis is about the treatment of patients with an acute manic episode. An acute manic episode is part of the Bipolar I Disorder, characterized by episodes of acute mania, episodes of depression and periods of remission. Only one acute manic episode in a lifetime is needed to meet criteria for Bipolar I Disorder (1). In this thesis, I focus on the treatment of the acute manic episode and leave the depressive episode of bipolar disorder aside. An acute manic episode is a dramatic and potentially very harmful period for patients and their loved ones. Patients can feel as if they are on top of the world, can be easily irritated, and may have feelings of grandiosity. Frequently, they have little need for sleep and therefore only sleep few hours a night. They often speak rapidly and continuously, and experience many thoughts running through their minds. They are easily distracted and can be extremely busy with social, work or school related or sexual activities. Unfortunately, they are often excessively preoccupied with activities that have high potential for serious harm, including interpersonal problems, extensive spending leading to serious debts and promiscuous behavior (1). An acute manic episode can last several weeks. When patients recover from an acute manic episode, they are frequently confronted with a personal, interpersonal, occupational and/or financial disaster due to the acute manic episode. Personal experiences as a resident at the psychiatric crisis department of Amsterdam (Arkin, Spoedeisende Psychiatrie) revealed the (self-) destructive behavior of several patients with an acute manic episode. There was a patient who sold his holiday home in Spain for only very little money, opened the door for strangers and gave away the entire furniture; a patient who walked naked on the streets of Amsterdam and had numerous sexual contacts; and a 76-years old patient who drunk day and night while dancing in her house in little and extravagant clothes. It was harrowing to see these patients in an acute manic episode, without boundaries and mostly without any sense of shame, a true motivation to study the treatment of an acute manic episode of bipolar disorder. Bipolar disorder is a lifelong condition, which unfortunately cannot be cured. Thus, one of the goals of treatment of patients with bipolar disorder is to prevent a new acute PART 1 - CHAPTER 1 - General introduction| 15 manic or depressive episode. Therefore, patients with bipolar disorder in remission are often treated with the mood stabilizer lithium, and less frequently with (anticonvulsant) mood stabilizers, antidepressants or antipsychotics, to prevent recurrence to an acute manic or depressive episode (2). However, due to serious life events, intense stress, inadequate medication, or discontinuation of medication (frequently occurring after a long episode-free period), a recurrence to mania or depression may still occur. When a recurrence to an acute manic episode occurs, the immediate treatment goal is to rapidly resolve manic symptoms. As recommended by the NICE Guideline for Bipolar Disorders (2014) and the Dutch Guidline for Bipolar Disorders (2015), the first choice in the treatment of acute mania is antipsychotic mono-therapy. If this is not effective, it is advised to switch to another antipsychotic compound and finally, adjuvant medication (e.g. lithium or valproate) is recommended (2). Preferably, only those antipsychotics should be prescribed for patients with an acute manic episode that are registered for this specific indication. In order to be registered (and thus obtain market authorization), the drug is tested on efficacy, safety, and quality in phase III randomized controlled clinical trials (RCTs). The drug has to show a significant and clinical relevant effect compared to placebo or to the established treatment and adverse events are assessed. If the registration authority (e.g. EMA, FDA) decides that there is a positive benefit-risk balance for the drug, registration and market authorization can be granted. This assessment can be challenging and the outcomes are often debated; were the patients in the trial really representative for those seen in daily clinical practice, were the outcome measures really the most adequate, was the magnitude of the effect really clinically relevant, and did the benefits really outweigh the risks, etcetera. To better understand and further improve clinical trials for the registration of treatment for acute mania, the Medicines Evaluation Board (MEB) of the Netherlands embarked on a collaborative project with the the Academic Medical Centre (AMC) at the University of Amsterdam. The MEB is grateful to the pharmaceutical companies for allowing us excess to their database. This database consisted of the raw individual patient data (IPD) of twelve registration studies for the indication of acute mania in an eleven-years period. All studies were double blind, randomized, placebo-controlled trials including 16 | DRUG TREATMENT FOR PATIENTS WITH ACUTE MANIA Understanding clinical trials and treatment success patients diagnosed with a DSM-IV acute manic episode of bipolar disorder. In this database, 3,207 patients were included; 1,403 patients received active treatment, 631 patients received an active comparator, and 1,191 patients received placebo. The mean age was 39.21, the mean BMI was 26.34, and 46% of patients was female. In our study, 59.2% of patients was Caucasian, 12.2% African American, 13.2% Asian, and 15.4% had another ethnic background. The studies assessed severity
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