The Bipolar Illness Onset study: Research protocol for the BIO cohort study

BMJ Open

Volumn 7, Issue 6, 2017, Pages

  Kessing, Lars Vedel ^a,b   Munkholm, Klaus ^a   Faurholt Jepsen, Maria ^a   Miskowiak, Kamilla Woznica ^a,b   Nielsen, Lars Bo ^b,c   Frikke Schmidt, Ruth ^b,c   Ekstrøm, Claus ^b   Winther, Ole ^b,d   Pedersen, Bente Klarlund ^c   Poulsen, Henrik Enghusen ^c   McIntyre, Roger S ^e   Kapczinski, Flavio ^f   Gattaz, Wagner F ^g   Bardram, Jakob ^d   Frost, Mads ^h   Mayora, Oscar ⁱ   Knudsen, Gitte Moos ^c   Phillips, Mary ^j   Vinberg, Maj ^a,c  

^a Psychiatric Center Copenhagen   (Denmark)

^b UNIVERSITY OF COPENHAGEN   (Denmark)

^c Rigshospitalet   (Denmark)

^d TECHNICAL UNIVERSITY OF DENMARK   (Denmark)

^e UNIVERSITY OF TORONTO   (Canada)

^f MCMASTER UNIVERSITY   (Canada)

^g UNIVERSITY OF SÃO PAULO   (Brazil)

^h IT UNIVERSITY OF COPENHAGEN   (Denmark)

ⁱ CREATE NET   (Italy)

^j UNIVERSITY OF PITTSBURGH   (United States)

more..

Author keywords

biomarker; bipolar disorder; cognition; Depression and mood disorders; MRI scanning; smartphone

Indexed keywords

BIOLOGICAL MARKER;

ADOLESCENT; ADULT; ARTICLE; BIPOLAR DEPRESSION; BIPOLAR I DISORDER; BIPOLAR II DISORDER; BIPOLAR MANIA; BLOOD SAMPLING; COGNITION; COHORT ANALYSIS; CONTROLLED STUDY; CYCLOTHYMIA; FAMILY HISTORY; FEASIBILITY STUDY; FUNCTIONAL MAGNETIC RESONANCE IMAGING; GENE EXPRESSION; HUMAN; INFLAMMATION; MAJOR CLINICAL STUDY; METHODOLOGY; NERVE CELL PLASTICITY; NEUROIMAGING; NEUROPSYCHOLOGICAL TEST; OXIDATIVE STRESS; RECURRENT DISEASE; RELAPSE; REMISSION; SMARTPHONE; AGED; BIPOLAR DISORDER; BLOOD; CASE CONTROL STUDY; DENMARK; DEPRESSION; DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS; FEMALE; LONGITUDINAL STUDY; MALE; MIDDLE AGED; PSYCHOLOGICAL RATING SCALE; REGRESSION ANALYSIS; SEVERITY OF ILLNESS INDEX; SIBLING; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; BIOMARKERS; BIPOLAR DISORDER; CASE-CONTROL STUDIES; DENMARK; DEPRESSION; DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS; FEMALE; HUMANS; LONGITUDINAL STUDIES; MALE; MIDDLE AGED; NEUROIMAGING; NEUROPSYCHOLOGICAL TESTS; PSYCHIATRIC STATUS RATING SCALES; RECURRENCE; REGRESSION ANALYSIS; RESEARCH DESIGN; SEVERITY OF ILLNESS INDEX; SIBLINGS; SMARTPHONE; YOUNG ADULT;

EID: 85021423333     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2016-015462     Document Type: Article

References (104)

1. Lohoff FW, Berettini WH. Genetics of bipolar disorder. In: Yatham LN, Maj M, eds. Bipolar disorder: clinical and neurobiological foundations. Singapore: wiley-blackwell, 2010:110-23.
2. Kessing LV, Hansen MG, Andersen PK, et al. The predictive effect of episodes on the risk of recurrence in depressive and bipolar disorders-a life-long perspective. Acta Psychiatr Scand 2004;109:339-44.
3. Kessing LV, Hansen MG, Andersen PK. Course of illness in depressive and bipolar disorders. naturalistic study, 1994-1999. Br J Psychiatry 2004;185:372-7.
4. Post RM, Fleming J, Kapczinski F. Neurobiological correlates of illness progression in the recurrent affective disorders. J Psychiatr Res 2012;46:561-73.
5. Schneider MR, DelBello MP, McNamara RK, et al. Neuroprogression in bipolar disorder. Bipolar Disord 2012;14:356-74.
6. Kessing LV, Nilsson FM. Increased risk of developing dementia in patients with Major affective disorders compared to patients with other medical illnesses. J Affect Disord 2003;73:261-9.
7. Kessing LV, Andersen PK. Does the risk of developing dementia increase with the number of episodes in patients with depressive disorder and in patients with bipolar disorder? J Neurol Neurosurg Psychiatry 2004;75:1662-6.
8. da Silva J, Gonçalves-Pereira M, Xavier M, et al. Affective disorders and risk of developing dementia: Systematic review. Br J Psychiatry 2013;202:177-86.
9. Kessing LV, Andersen PK. Evidence for clinical progression of unipolar and bipolar disorders. Acta Psychiatr Scand 2017;135:51-64. in press.
10. Kessing LV. Diagnostic stability in bipolar disorder in clinical practise as according to ICD-10. J Affect Disord 2005;85:293-9.
11. Baldessarini RJ, Tondo L, Baethge CJ, et al. Effects of treatment latency on response to maintenance treatment in manic-depressive disorders. Bipolar Disord 2007;9:386-93.
12. Phillips ML, Kupfer DJ. Bipolar disorder diagnosis: challenges and future directions. Lancet 2013;381:1663-71.
13. Papakostas GI, Shelton RC, Kinrys G, et al. Assessment of a multi-assay, serum-based biological diagnostic test for major depressive disorder: A pilot and replication study. Mol Psychiatry 2013;18:332-9.
14. Fries GR, Pfaffenseller B, Stertz L, et al. Staging and neuroprogression in bipolar disorder. Curr Psychiatry Rep 2012;14:667-75.
15. Berk M, Berk L, Dodd S, et al. Stage managing bipolar disorder. Bipolar Disord 2014;16:471-7.
16. McIntyre RS, Correll C. Predicting and preventing bipolar disorder: the need to fundamentally advance the strategic approach. Bipolar Disord 2014;16:451-4. in press.
17. Grande I, Magalhães PV, Chendo I, et al. Staging bipolar disorder: clinical, biochemical, and functional correlates. Acta Psychiatr Scand 2014;129:437-44.
18. Kapczinski F, Magalhães PV, Balanzá-Martinez V, et al. Staging systems in bipolar disorder: An International Society for Bipolar Disorders Task Force Report. Acta Psychiatr Scand 2014;130:354-63.
19. Kessing LV, Hansen HV, Hvenegaard A, et al. Treatment in a specialised out-patient mood disorder clinic v. standard out-patient treatment in the early course of bipolar disorder: randomised clinical trial. Br J Psychiatry 2013;202:212-9.
20. First MB, Spitzer M, Gibbon M, et al. Structured clinical interview for DSM-IV-TR Axis I Disorders. New York: Biometrics Research Department, New York State Psychiatric Institute, New York, 2002.
21. Wing JK, Babor T, Brugha T, et al. SCAN. Schedules for Clinical Assessment in Neuropsychiatry. Arch Gen Psychiatry 1990;47:589-93.
22. Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960;23:56-62.
23. Young RC, Biggs JT, Ziegler VE, et al. A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry 1978;133:429-35.
24. Vinberg M, Miskowiak K, Kessing LV. Risk markers for affective disorder, a seven-years follow up study of a twin cohort at low and high risk for affective disorder. J Psychiatr Res 2013;47:565-71.
25. Hillegers MH, Reichart CG, Wals M, et al. Five-year prospective outcome of psychopathology in the adolescent offspring of bipolar parents. Bipolar Disord 2005;7:344-50.
26. Rosa AR, Sánchez-Moreno J, Martínez-Aran A, et al. Validity and reliability of the Functioning Assessment Short Test (FAST) in bipolar disorder. Clin Pract Epidemiol Ment Health 2007;3:5.
27. Angst J, Adolfsson R, Benazzi F, et al. The HCL-32: towards a selfassessment tool for hypomanic symptoms in outpatients. J Affect Disord 2005;88:217-33.
28. Bukh JD, Bock C, Vinberg M, et al. Clinical utility of Standardised Assessment of Personality-Abbreviated Scale (SAPAS) among patients with first episode depression. J Affect Disord 2010;127:199-202.
29. Bech P, Olsen LR, Kjoller M, et al. Measuring well-being rather than the absence of distress symptoms: A comparison of the SF-36 Mental Health subscale and the WHO-Five Well-Being Scale. Int J Methods Psychiatr Res 2003;12:85-91.
30. Kessing LV, Hansen HV, Ruggeri M, et al. Satisfaction with treatment among patients with depressive and bipolar disorders. Soc Psychiatry Psychiatr Epidemiol 2006;41:148-55.
31. Stalder T, Kirschbaum C. Analysis of cortisol in hair-state of the art and future directions. Brain Behav Immun 2012;26:1019-29.
32. Faurholt-Jepsen M, Brage S, Vinberg M, et al. Differences in psychomotor activity in patients suffering from unipolar and bipolar affective disorder in the remitted or mild/moderate depressive state. J Affect Disord 2012;141:457-63.
33. Faurholt-Jepsen M, Brage S, Vinberg M, et al. State-related differences in the level of psychomotor activity in patients with bipolar disorder-Continuous heart rate and movement monitoring. Psychiatry Res 2016;237:166-74.
34. Munkholm K, Vinberg M, Vedel Kessing L. Cytokines in bipolar disorder: A systematic review and meta-analysis. J Affect Disord 2013;144:16-27.
35. Munkholm K, Braüner JV, Kessing LV, et al. Cytokines in bipolar disorder vs. healthy control subjects: A systematic review and metaanalysis. J Psychiatr Res 2013;47:1119-33.
36. Munkholm K, Vinberg M, Berk M, et al. State-related alterations of gene expression in bipolar disorder: A systematic review. Bipolar Disord 2012;14:684-96.
37. Munkholm K, Vinberg M, Kessing LV. Peripheral blood brain-derived neurotrophic factor in bipolar disorder: A comprehensive systematic review and meta-analysis. Mol Psychiatry 2016;21:216-28.
38. Frey BN, Andreazza AC, Houenou J, et al. Biomarkers in bipolar disorder: A positional paper from the International Society for bipolar Disorders biomarkers Task Force. Aust N Z J Psychiatry 2013;47:321-32.
39. Munkholm K, Pedersen BK, Kessing LV, et al. Elevated levels of plasma brain derived neurotrophic factor in rapid cycling bipolar disorder patients. Psychoneuroendocrinology 2014;47:199-211.
40. Jacoby AS, Vinberg M, Poulsen HE, et al. Increased DNA and RNA damage by oxidation in patients with bipolar I disorder. Transl Psychiatry 2016;6:e867.
41. Munkholm K, Poulsen HE, Kessing LV, et al. Elevated levels of urinary markers of oxidatively generated DNA and RNA damage in bipolar disorder. Bipolar Disord 2015;17:257-68.
42. Munkholm K, Peijs L, Kessing LV, et al. Reduced mRNA expression of PTGDS in peripheral blood mononuclear cells of rapid-cycling bipolar disorder patients compared with healthy control subjects. Int J Neuropsychopharmacol 2014;18:pyu101.
43. Jacoby AS, Munkholm K, Vinberg M, et al. Glycogen synthase kinase-3 in patients with bipolar I disorder: results from a prospective study. Bipolar Disord 2016;18:334-41.
44. Munkholm K, Weikop P, Kessing LV, et al. Elevated levels of IL-6 and IL-18 in manic and hypomanic states in rapid cycling bipolar disorder patients. Brain Behav Immun 2015;43:205-13.
45. Goldstein BI, Young LT. Toward clinically applicable biomarkers in bipolar disorder: focus on BDNF, inflammatory markers, and endothelial function. Curr Psychiatry Rep 2013;15:425.
46. Munkholm K, Peijs L, Vinberg M, et al. A composite peripheral blood gene expression measure as a potential diagnostic biomarker in bipolar disorder. Transl Psychiatry 2015;5:e614.
47. Dickerson F, Schroeder J, Stallings C, et al. Multianalyte markers of schizophrenia and bipolar disorder: A preliminary study. Schizophr Res 2015;168:450-5.
48. Haenisch F, Cooper JD, Reif A, et al. Towards a blood-based diagnostic panel for bipolar disorder. Brain Behav Immun 2016;52:49-57.
49. Berk M, Conus P, Lucas N, et al. Setting the stage: from prodrome to treatment resistance in bipolar disorder. Bipolar Disord 2007;9:671-8.
50. Brink-Jensen K, Bak S, Jørgensen K, et al. Integrative analysis of metabolomics and transcriptomics data: A unified model framework to identify underlying system pathways. PLoS One 2013;8:e72116.
51. Hastie T, Tibshirani R, Friedman J. Penalised regression. The elements of Statistical Learning: Data Mining, Inference, and prediction. 2nd ed: Spring Verlag, 2009.
52. Phelps J, Ghaemi SN. The mistaken claim of bipolar 'overdiagnosis': Solving the false positives problem for DSM-5/ICD-11 Acta Psychiatr Scand 2012;126:395-401.
53. Bopp JM, Miklowitz DJ, Goodwin GM, et al. The longitudinal course of bipolar disorder as revealed through weekly text messaging: A feasibility study. Bipolar Disord 2010;12:327-34.
54. Bardram JE, Frost M, Szántó K, et al, Designing mobile health technology for bipolar disorder: A field trial of the MONARCA System. Proceedings of the SIGCHI Conference on Human Factors in Computing Systems. 2013; 2627-36
55. Faurholt-Jepsen M, Frost M, Ritz C, et al. Daily electronic selfmonitoring in bipolar disorder using smartphones-the MONARCA I trial: A randomized, placebo-controlled, single-blind, parallel group trial. Psychol Med 2015;45:2691-704.
56. Frost M, Doryab A, Faurholt-Jepsen M, et al. Supportingdisease insight through data analysis: refinements of the monarca selfassessment system. Proceedings of the 2013 ACM international joint conference on Pervasive andubiquitous computing. New York, NY, USA: ACM Press, 20143.
57. Bardram JE, Frost M, Szántó, K, et al. The MONARCA selfassessment system: A persuasive personal monitoring system for bipolar patients. Proceedings of the 2nd ACM SIGHIT International Health Informatics Symposium (IHI '12). New York, NY, USA: ACM, 2012:21-30.
58. Gravenhorst F, Muaremi A, Bardram J, et al. Mobile phones as medical devices in mental disorder treatment: An overview. Pers Ubiquitous Comput 2015;19:335-53.
59. Faurholt-Jepsen M, Frost M, Vinberg M, et al. Smartphone data as objective measures of bipolar disorder symptoms. Psychiatry Res 2014;217:124-7.
60. Faurholt-Jepsen M, Vinberg M, Frost M, et al. Smartphone data as an electronic biomarker of illness activity in bipolar disorder. Bipolar Disord 2015;17:715-28.
61. Faurholt-Jepsen M, Busk J, Frost M, et al. Voice analysis as an objective state marker in bipolar disorder. Transl Psychiatry 2016;6:e856.
62. Faedda GL, Ohashi K, Hernandez M, et al. Actigraph measures discriminate pediatric bipolar disorder from attention-deficit/hyperactivity disorder and typically developing controls. J Child Psychol Psychiatry 2016;57:706-16.
63. Indic P, Salvatore P, Maggini C, et al. Scaling behavior of human locomotor activity amplitude: Association with bipolar disorder. PLoS One 2011;6:e20650.
64. Valenza G, Nardelli M, Lanatà A, et al. Wearable monitoring for mood recognition in bipolar disorder based on history-dependent long-term heart rate variability analysis. IEEE J Biomed Health Inform 2014;18:1625-35.
65. Torres IJ, Boudreau VG, Yatham LN. Neuropsychological functioning in euthymic bipolar disorder: A meta-analysis. Acta Psychiatr Scand Suppl 2007:17-26.
66. Bora E, Yucel M, Pantelis C. Cognitive endophenotypes of bipolar disorder: A meta-analysis of neuropsychological deficits in euthymic patients and their first-degree relatives. J Affect Disord 2009;113:1-20.
67. Mann-Wrobel MC, Carreno JT, Dickinson D. Meta-analysis of neuropsychological functioning in euthymic bipolar disorder: An update and investigation of moderator variables. Bipolar Disord 2011;13:334-42.
68. Bourne C, Aydemir Ö, Balanzá-Martínez V, et al. Neuropsychological testing of cognitive impairment in euthymic bipolar disorder: An individual patient data meta-analysis. Acta Psychiatr Scand 2013;128:149-62.
69. Depp CA, Mausbach BT, Harmell AL, et al. Meta-analysis of the association between cognitive abilities and everyday functioning in bipolar disorder. Bipolar Disord 2012;14:217-26.
70. Rosa AR, Magalhães PV, Czepielewski L, et al. Clinical staging in bipolar disorder: focus on cognition and functioning. J Clin Psychiatry 2014;75:e450-e456.
71. Samamé C, Martino DJ, Strejilevich SA. Longitudinal course of cognitive deficits in bipolar disorder: A meta-analytic study. J Affect Disord 2014;164:130-8.
72. Kessing LV, Olsen EW, Mortensen PB, et al. Dementia in affective disorder: A case-register study. Acta Psychiatr Scand 1999;100:176-85.
73. Wu KY, Chang CM, Liang HY, et al. Increased risk of developing dementia in patients with bipolar disorder: A nested matched casecontrol study. Bipolar Disord 2013;15:787-94.
74. Chen MH, Li CT, Tsai CF, et al. Risk of subsequent dementia among patients with bipolar disorder or Major depression: A nationwide longitudinal study in Taiwan. J Am Med Dir Assoc 2015;16:504-8.
75. Strakowski SM, Adler CM, Holland SK, et al. A preliminary FMRI study of sustained attention in euthymic, unmedicated bipolar disorder. Neuropsychopharmacology 2004;29:1734-40.
76. Kerr N, Dunbar RI, Bentall RP. Theory of mind deficits in bipolar affective disorder. J Affect Disord 2003;73:253-9.
77. Wessa M, Linke J. Emotional processing in bipolar disorder: behavioural and neuroimaging findings. Int Rev Psychiatry 2009;21:357-67.
78. Phillips ML, Swartz HA. A critical appraisal of neuroimaging studies of bipolar disorder: toward a new conceptualization of underlying neural circuitry and a road map for future research. Am J Psychiatry 2014;171:829-43.
79. Hallahan B, Newell J, Soares JC, et al. Structural magnetic resonance imaging in bipolar disorder: An international collaborative mega-analysis of individual adult patient data. Biol Psychiatry 2011;69:326-35.
80. Mora E, Portella MJ, Forcada I, et al. Persistence of cognitive impairment and its negative impact on psychosocial functioning in lithium-treated, euthymic bipolar patients: A 6-year follow-up study. Psychol Med 2013;43:1187-96.
81. Bauer IE, Pascoe MC, Wollenhaupt-Aguiar B, et al. Inflammatory mediators of cognitive impairment in bipolar disorder. J Psychiatr Res 2014;56:18-27.
82. Lim CS, Baldessarini RJ, Vieta E, et al. Longitudinal neuroimaging and neuropsychological changes in bipolar disorder patients: review of the evidence. Neurosci Biobehav Rev 2013;37:418-35.
83. Balanzá-Martínez V, Rubio C, Selva-Vera G, et al. Neurocognitive endophenotypes (endophenocognitypes) from studies of relatives of bipolar disorder subjects: A systematic review. Neurosci Biobehav Rev 2008;32:1426-38.
84. Raust A, Daban C, Cochet B, et al. Neurocognitive performance as an endophenotype for bipolar disorder. Front Biosci 2014;6:89-103.
85. Rey A. Psychological examination of traumatic encephalopathy. Archieves de Psychologic 1941;28:286-340.
86. Rey A. L'examen clinique en psychologie Clinical tests in psychology. Paris: Presses Universitaires de France, 1964.
87. Kjærstad HL, Vinberg M, Goldin PR, et al. Impaired down-regulation of negative emotion in self-referent social situations in bipolar disorder: A pilot study of a novel experimental paradigm. Psychiatry Res 2016;238:318-25.
88. Chase HW, Nusslock R, Almeida JR, et al. Dissociable patterns of abnormal frontal cortical activation during anticipation of an uncertain reward or loss in bipolar versus major depression. Bipolar Disord 2013;15:839-54.
89. Miskowiak K, O'Sullivan U, Harmer CJ. Erythropoietin enhances hippocampal response during memory retrieval in humans. J Neurosci 2007;27:2788-92.
90. Garnefski N, Kraaij V, Spinhoven P. Negative life events, cognitive emotion regulation and emotional problems. Pers Individ Dif 2001;30:1311-27.
91. Winkler AM, Ridgway GR, Webster MA, et al. Permutation inference for the general linear model. Neuroimage 2014;92:381-97.
92. Miskowiak K, O'Sullivan U, Harmer CJ. Erythropoietin reduces neural and cognitive processing of fear in human models of antidepressant drug action. Biol Psychiatry 2007;62:1244-50.
93. Miskowiak KW, Glerup L, Vestbo C, et al. Different neural and cognitive response to emotional faces in healthy monozygotic twins at risk of depression. Psychol Med 2015;45:1447-58.
94. Miskowiak KW, Vinberg M, Macoveanu J, et al. Effects of erythropoietin on hippocampal volume and memory in mood disorders. Biol Psychiatry 2015;78:270-7.
95. Miskowiak KW, Macoveanu J, Vinberg M, et al. Effects of erythropoietin on memory-relevant neurocircuitry activity and recall in mood disorders. Acta Psychiatr Scand 2016;134:249-59.
96. Miskowiak KW, Vinberg M, Glerup L, et al. Neural correlates of improved executive function following erythropoietin treatment in mood disorders. Psychol Med 2016;46:1679-91.
97. Brietzke E, Mansur RB, Soczynska JK, et al. Towards a multifactorial approach for prediction of bipolar disorder in at risk populations. J Affect Disord 2012;140:82-91.
98. Weissman MM, Wickramaratne P, Adams P, et al. Brief screening for family psychiatric history: the family history screen. Arch Gen Psychiatry 2000;57:675-82.
99. Gallo V, Egger M, McCormack V, et al. Strengthening the Reporting of Observational studies in Epidemiology-Molecular Epidemiology (STROBE-ME): An extension of the STROBE statement. Eur J Clin Invest 2012;42:1-16.
100. von Elm E, Altman DG, Egger M, et al. The Strengthening the Reporting of Observational studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies. Int J Surg 2014;12:1495-9.
101. van den Ameele S, van Diermen L, Staels W, et al. The effect of mood-stabilizing drugs on cytokine levels in bipolar disorder: A systematic review. J Affect Disord 2016;203:364-73.
102. Jacoby AS, Munkholm K, Vinberg M, et al. Cytokines, brain-derived neurotrophic factor and C-reactive protein in bipolar I disorder-Results from a prospective study. J Affect Disord 2016;197:167-74.
103. Laidi C, Houenou J. Brain functional effects of psychopharmacological treatments in bipolar disorder. Eur Neuropsychopharmacol 2016;26:1695-740.
104. Munkholm K, Lenskjold T, Jacoby AS, et al. Glycogen synthase Kinase-3?: variation over time and the possible association with mood and cognition in healthy individuals. Neuropsychobiology 2016;73:108-15.