Methodological recommendations for cognition trials in bipolar disorder by the International Society for Bipolar Disorders Targeting Cognition Task Force

Bipolar Disorders

Volumn 19, Issue 8, 2017, Pages 614-626

  Miskowiak, K W ^a,b   Burdick, K E ^c   Martinez Aran, A ^d   Bonnin, C M ^d   Bowie, C R ^e   Carvalho, A F ^f   Gallagher, P ^g   Lafer, B ^h   Lopez Jaramillo C ⁱ   Sumiyoshi, T ^j   McIntyre, R S ^k   Schaffer, A ^k   Porter, R J ^l   Torres, I J ^m   Yatham, L N ^m   Young, A H ⁿ   Kessing, L V ^a   Vieta, E ^d  

^a Rigshospitalet   (Denmark)

^b UNIVERSITY OF COPENHAGEN   (Denmark)

^c BRIGHAM AND WOMEN S HOSPITAL   (United States)

^d UNIVERSITY OF BARCELONA   (Spain)

^e QUEEN S UNIVERSITY   (Canada)

^f FEDERAL UNIVERSITY OF CEARÁ   (Brazil)

^g NEWCASTLE UNIVERSITY   (United Kingdom)

^h UNIVERSITY OF SÃO PAULO   (Brazil)

ⁱ UNIVERSIDAD DE ANTIOQUIA   (Colombia)

^j NATIONAL INSTITUTE OF MENTAL HEALTH   (Japan)

^k UNIVERSITY OF TORONTO   (Canada)

^l UNIVERSITY OF OTAGO   (New Zealand)

^m UNIVERSITY OF BRITISH COLUMBIA   (Canada)

ⁿ KING'S COLLEGE LONDON   (United Kingdom)

more..

Author keywords

bipolar disorder; cognitive impairment; methodology; recommendations; treatment

Indexed keywords

ERYTHROPOIETIN;

BIPOLAR DISORDER; COGNITION; COGNITIVE DEFECT; CONSENSUS; E-MAIL; HUMAN; MEDICAL SOCIETY; MOOD DISORDER; NEUROIMAGING; NONHUMAN; OUTCOME ASSESSMENT; PRACTICE GUIDELINE; PRIORITY JOURNAL; REVIEW; ADVISORY COMMITTEE; CLINICAL TRIAL (TOPIC); COMPLICATION; DISEASE MANAGEMENT; METHODOLOGY; ORGANIZATION AND MANAGEMENT; PSYCHOLOGY; TREATMENT OUTCOME;

ADVISORY COMMITTEES; BIPOLAR DISORDER; CLINICAL TRIALS AS TOPIC; COGNITION; COGNITION DISORDERS; CONSENSUS; DISEASE MANAGEMENT; HUMANS; RESEARCH DESIGN; TREATMENT OUTCOME;

EID: 85029312051     PISSN: 13985647     EISSN: 13995618     Source Type: Journal    
DOI: 10.1111/bdi.12534     Document Type: Review

References (83)

1. Miskowiak KW, Carvalho AF, Vieta E, Kessing LV. Cognitive enhancement treatments for bipolar disorder: a systematic review and methodological recommendations. Eur Neuropsychopharmacol. 2016;26(10):1541-1561.
2. Bourne C, Aydemir O, Balanza-Martinez V, Bora E, Brissos S, Cavanagh JT, et al. Neuropsychological testing of cognitive impairment in euthymic bipolar disorder: an individual patient data meta-analysis. Acta Psychiatr Scand. 2013;128:149-162.
3. Martinez-Aran A, Vieta E, Reinares M, Colom F, Torrent C, Sanchez-Moreno J, et al. Cognitive function across manic or hypomanic, depressed, and euthymic states in bipolar disorder. Am J Psychiatry. 2004;161:262-270.
4. Goldberg JF, Burdick KE. Cognitive Dysfunction in Bipolar Disorder - A Guide for Clinicians. Washington, DC: American Psychiatric Publishing; 2008.
5. Vieta E. The influence of medications on neurocognition in bipolar disorder. Acta Psychiatr Scand. 2009;120:414-415.
6. Burdick KE, Russo M, Frangou S, Mahon K, Braga RJ, Shanahan M, et al. Empirical evidence for discrete neurocognitive subgroups in bipolar disorder: clinical implications. Psychol Med. 2014;44:3083-3096.
7. Jensen JH, Knorr U, Vinberg M, Kessing LV, Miskowiak KW. Discrete neurocognitive subgroups in fully or partially remitted bipolar disorder. J Affect Disord. 2016;15(205):378-386.
8. Sole B, Jimenez E, Torrent C, del Mar BC, Torres I, Reinares M, et al. Cognitive variability in bipolar II disorder: who is cognitively impaired and who is preserved. Bipolar Disord. 2016;18:288-299.
9. Burdick KE, Ketter TA, Goldberg JF, Calabrese JR. Assessing cognitive function in bipolar disorder: challenges and recommendations for clinical trial design. J Clin Psychiatry. 2015;76:e342-e350.
10. Yatham LN, Torres IJ, Malhi GS, Frangou S, Glahn DC, Bearden CE, et al. The International Society for Bipolar Disorders-Battery for Assessment of Neurocognition (ISBD-BANC). Bipolar Disord. 2010;12:351-363.
11. Bonnin CM, Reinares M, Martinez-Aran A, Balanza-Martinez V, Sole B, Torrent C, et al. Effects of functional remediation on neurocognitively impaired bipolar patients: enhancement of verbal memory. Psychol Med. 2015;21:1-11.
12. Burdick KE, Braga RJ, Nnadi CU, Shaya Y, Stearns WH, Malhotra AK. Placebo-controlled adjunctive trial of pramipexole in patients with bipolar disorder: targeting cognitive dysfunction. J Clin Psychiatry. 2012;73:103-112.
13. Torrent C, Bonnin CM, Martinez-Aran A, Valle J, Amann BL, Gonzalez-Pinto A, et al. Efficacy of functional remediation in bipolar disorder: a multicenter randomized controlled study. Am J Psychiatry. 2013;170:852-859.
14. Miskowiak KW, Rush AJ, Gerds TA, Vinberg M, Kessing LV. Targeting treatments to improve cognitive function in mood disorder: suggestions from trials using erythropoietin. J Clin Psychiatry. 2016;77:e1639-e1646.
15. Ott CV, Vinberg M, Kessing LV, Miskowiak KW. The effect of erythropoietin on cognition in affective disorders - Associations with baseline deficits and change in subjective cognitive complaints. Eur Neuropsychopharmacol. 2016;26:1264-1273.
16. Yatham LN, Mackala S, Basivireddy J, Ahn S, Walji N, Hu C, et al. Lurasidone versus treatment as usual for cognitive impairment in euthymic patients with bipolar I disorder: a randomised, open-label, pilot study. Lancet Psychiatry. 2017;4(3):208-217.
17. Demant KM, Vinberg M, Kessing LV, Miskowiak KW. Assessment of subjective and objective cognitive function in bipolar disorder: correlations, predictors and the relation to psychosocial function. Psychiatry Res. 2015;229:565-571.
18. Jensen JH, Støttrup MM, Nayberg E, Knorr U, Ullum H, Purdon SE, et al. Optimising screening for cognitive dysfunction in bipolar disorder: validation and evaluation of objective and subjective tools. J Affect Disord. 2015;187:19.
19. Miskowiak KW, Petersen JZ, Ott CV, Knorr U, Kessing LV, Gallagher P, et al. Predictors of the discrepancy between objective and subjective cognition in bipolar disorder: a novel methodology. Acta Psychiatr Scand. 2016;134:511-521.
20. Tse S, Chan S, Ng KL, Yatham LN. Meta-analysis of predictors of favorable employment outcomes among individuals with bipolar disorder. Bipolar Disord. 2014;16:217-229.
21. Rosa AR, Mercade C, Sanchez-Moreno J, Sole B, Mar Bonnin CD, Torrent C, et al. Validity and reliability of a rating scale on subjective cognitive deficits in bipolar disorder (COBRA). J Affect Disord. 2013 Aug;15(150):29-36.
22. Purdon S. The Screen for Cognitive Impairment in Psychiatry: administration and Psychometric Properties. Edmonton, Alberta, Canada: PNL Inc.; 2005.
23. Guilera G, Pino O, Gomez-Benito J, Rojo JE, Vieta E, Tabares-Seisdedos R, et al. Clinical usefulness of the screen for cognitive impairment in psychiatry (SCIP-S) scale in patients with type I bipolar disorder. Health Qual Life Outcomes. 2009;7:28.
24. Rojo E, Pino O, Guilera G, Gomez-Benito J, Purdon SE, Crespo-Facorro B, et al. Neurocognitive diagnosis and cut-off scores of the Screen for Cognitive Impairment in Psychiatry (SCIP-S). Schizophr Res. 2010;116(2–3):243-251.
25. Gualtieri CT, Morgan DW. The frequency of cognitive impairment in patients with anxiety, depression, and bipolar disorder: an unaccounted source of variance in clinical trials. J Clin Psychiatry. 2008;69:1122-1130.
26. Petersen RC, Stevens JC, Ganguli M, Tangalos EG, Cummings JL, DeKosky ST. Practice parameter: early detection of dementia: mild cognitive impairment (an evidence-based review). Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2001;8(56):1133-1142.
27. Yilmaz R, Graber S, Roeben B, Suenkel U, von Thaler AK, Heinzel S, et al. Cognitive performance patterns in healthy individuals with substantia nigra hyperechogenicity and early parkinson's disease. Front Aging Neurosci. 2016;8:271.
28. Stern RA, Silva SG, Chaisson N, Evans DL. Influence of cognitive reserve on neuropsychological functioning in asymptomatic human immunodeficiency virus-1 infection. Arch Neurol. 1996;53:148-153.
29. Forcada I, Mur M, Mora E, Vieta E, Bartres-Faz D, Portella MJ. The influence of cognitive reserve on psychosocial and neuropsychological functioning in bipolar disorder. Eur Neuropsychopharmacol. 2015;25:214-222.
30. Grande I, Sanchez-Moreno J, Sole B, Jimenez E, Torrent C, Bonnin CM, et al. High cognitive reserve in bipolar disorders as a moderator of neurocognitive impairment. J Affect Disord. 2016;S0165–0327:31330-31331.
31. Glahn DC, Bearden CE, Bowden CL, Soares JC. Reduced educational attainment in bipolar disorder. J Affect Disord. 2006;92:309-312.
32. Toniolo RA, Fernandes FB, Silva M, Dias RD, Lafer B. Cognitive effects of creatine monohydrate adjunctive therapy in patients with bipolar depression: results from a randomized, double-blind, placebo-controlled trial. J Affect Disord. 2016;pii:S0165-0327 32114-0.
33. Porter RJ, Robinson LJ, Malhi GS, Gallagher P. The neurocognitive profile of mood disorders - a review of the evidence and methodological issues. Bipolar Disord. 2015;17(Suppl 2):21-40.
34. Thompson JM, Gallagher P, Hughes JH, Watson S, Gray JM, Ferrier IN, et al. Neurocognitive impairment in euthymic patients with bipolar affective disorder. Br J Psychiatry. 2005;186:32-40.
35. Watson S, Gallagher P, Ritchie JC, Ferrier IN, Young AH. Hypothalamic-pituitary-adrenal axis function in patients with bipolar disorder. Br J Psychiatry. 2004;184:496-502.
36. Pavlova B, Perlis RH, Alda M, Uher R. Lifetime prevalence of anxiety disorders in people with bipolar disorder: a systematic review and meta-analysis. Lancet Psychiatry. 2015;2:710-717.
37. Bradley AJ, Webb-Mitchell R, Hazu A, Slater N, Middleton B, Gallagher P, et al. Sleep and circadian rhythm disturbance in bipolar disorder. Psychol Med. 2017;47:1678-1689.
38. Watson S, Gallagher P, Porter RJ, Smith MS, Herron LJ, Bulmer S, et al. A randomized trial to examine the effect of mifepristone on neuropsychological performance and mood in patients with bipolar depression. Biol Psychiat. 2012;1(72):943-949.
39. Young AH, Gallagher P, Watson S, Del-Estal D, Owen BM, Ferrier IN. Improvements in neurocognitive function and mood following adjunctive treatment with mifepristone (RU-486) in bipolar disorder. Neuropsychopharmacology. 2004;29:1538-1545.
40. Miskowiak KW, Ehrenreich H, Christensen EM, Kessing LV, Vinberg M. Recombinant human erythropoietin to target cognitive dysfunction in bipolar disorder: a double-blind, randomized, placebo-controlled phase 2 trial. J Clin Psychiatry. 2014;75:1347-1355.
41. Burdick KE, Goldberg TE, Cornblatt BA, Keefe RS, Gopin CB, Derosse P, et al. The MATRICS consensus cognitive battery in patients with bipolar I disorder. Neuropsychopharmacology. 2011;36:1587-1592.
42. Sperry SH, O'Connor LK, Ongur D, Cohen BM, Keshavan MS, Lewandowski KE. Measuring cognition in bipolar disorder with psychosis using the MATRICS consensus cognitive battery. J Int Neuropsychol Soc. 2015;21:468-472.
43. Van Rheenen TE, Rossell SL. An empirical evaluation of the MATRICS consensus cognitive battery in bipolar disorder. Bipolar Disord. 2014;16:318-325.
44. Fulford D, Peckham AD, Johnson K, Johnson SL. Emotion perception and quality of life in bipolar I disorder. J Affect Disord. 2014;152–154:491-497.
45. Hoertnagl CM, Biedermann F, Yalcin-Siedentopf N, Muehlbacher M, Rauch AS, Baumgartner S, et al. Prosodic and semantic affect perception in remitted patients with bipolar I disorder. J Clin Psychiatry. 2015;76:e779-e786.
46. Miskowiak KW, Vinberg M, Harmer CJ, Ehrenreich H, Knudsen GM, Macoveanu J, et al. Effects of erythropoietin on depressive symptoms and neurocognitive deficits in depression and bipolar disorder. Trials. 2010;11:97.
47. Buchanan RW, Davis M, Goff D, Green MF, Keefe RS, Leon AC, et al. A summary of the FDA-NIMH-MATRICS workshop on clinical trial design for neurocognitive drugs for schizophrenia. Schizophr Bull. 2005;31(1):5-19.
48. McIntyre RS, Florea I, Tonnoir B, Loft H, Lam RW, Christensen MC. Efficacy of vortioxetine on cognitive functioning in working patients with major depressive disorder. J Clin Psychiatry. 2017;78:115-121.
49. Rosa AR, Sanchez-Moreno J, Martinez-Aran A, Salamero M, Torrent C, Reinares M, et al. Validity and reliability of the Functioning Assessment Short Test (FAST) in bipolar disorder. Clin Pract Epidemiol Ment Health. 2007;3:5.
50. Patterson TL, Goldman S, McKibbin CL, Hughs T, Jeste DV. UCSD performance-based skills assessment: development of a new measure of everyday functioning for severely mentally ill adults. Schizophr Bull. 2001;27:235-245.
51. Keefe RS, Davis VG, Atkins AS, Vaughan A, Patterson T, Narasimhan M, et al. Validation of a computerized test of functional capacity. Schizophr Res. 2016;175:90-96.
52. Kaser M, Deakin J, Michael A, Zapata C, Bansal R, Ryan D, et al. Modafinil improves episodic memory and working memory cognition in patients with remitted depression: a double-blind, randomized, placebo-controlled study. Biological Psychiatry CNNI. 2017; 2:115-122.
53. Aimone JB, Wiles J, Gage FH. Potential role for adult neurogenesis in the encoding of time in new memories. Nat Neurosci. 2006;9:723-727.
54. McIntyre RS, Harrison J, Loft H, Jacobson W, Olsen CK. The effects of vortioxetine on cognitive function in patients with major depressive disorder: a meta-analysis of three randomized controlled trials. Int J Neuropsychopharmacol. 2016; pii: pyw055.
55. Bet PM, Franken LG, Klumpers UM. Could pramipexole induce acute mania? A case report Bipolar disorder. 2013;15:446-448.
56. Malhi GS, Byrow Y, Bassett D, Boyce P, Hopwood M, Lyndon W, et al. Stimulants for depression: on the up and up? Aust N Z J Psychiatry. 2016;50:203-207.
57. Corp SA, Gitlin MJ, Altshuler LL. A review of the use of stimulants and stimulant alternatives in treating bipolar depression and major depressive disorder. J Clin Psychiatry. 2014;75:1010-1018.
58. Fawcett J, Rush AJ, Vukelich J, Diaz SH, Dunklee L, Romo P, et al. Clinical experience with high-dosage pramipexole in patients with treatment-resistant depressive episodes in unipolar and bipolar depression. Am J Psychiatry. 2016;173:107-111.
59. Burdick KE, Braga RJ, Gopin CB, Malhotra AK. Dopaminergic influences on emotional decision making in euthymic bipolar patients. Neuropsychopharmacology. 2014;39:274-282.
60. Maud C. Vortioxetine in bipolar depression induces a mixed/manic switch. Australas Psychiatry. 2016;24:206-207.
61. FDA Critical Path Initiative. http://www.fda.gov/oc/initiatives/criticalpath/ http://www.nimh.nih.gov/about/director/2014/a-new-approach-to-clinical-trials.shtml
62. Gandelman-Marton R, Aichenbaum S, Dobronevsky E, Khaigrekht M, Rabey JM. Quantitative EEG after brain stimulation and cognitive training in alzheimer disease. J Clin Neurophysiol. 2017;34:49-54.
63. Yang JC, Rodriguez A, Royston A, et al. Memantine improves attentional processes in fragile X-associated tremor/ataxia syndrome: electrophysiological evidence from a randomized controlled trial. Sci Rep. 2016;6:21719.
64. Dietsche B, Backes H, Stratmann M, Konrad C, Kircher T, Krug A. Altered neural function during episodic memory encoding and retrieval in major depression. Hum Brain Mapp. 2014;35:4293-4302.
65. Fernandez-Corcuera P, Salvador R, Monte GC, Salvador SS, Goikolea JM, Amann B, et al. Bipolar depressed patients show both failure to activate and failure to de-activate during performance of a working memory task. J Affect Disord. 2013;148:170-178.
66. Frangou S, Kington J, Raymont V, Shergill SS. Examining ventral and dorsal prefrontal function in bipolar disorder: a functional magnetic resonance imaging study. Eur Psychiatry. 2008;23:300-308.
67. Hamilton LS, Altshuler LL, Townsend J, Bookheimer SY, Phillips OR, Fischer J, et al. Alterations in functional activation in euthymic bipolar disorder and schizophrenia during a working memory task. Hum Brain Mapp. 2009;30:3958-3969.
68. Minzenberg MJ, Laird AR, Thelen S, Carter CS, Glahn DC. Meta-analysis of 41 functional neuroimaging studies of executive function in schizophrenia. Arch Gen Psychiatry. 2009;66:811-822.
69. Monks PJ, Thompson JM, Bullmore ET, Suckling J, Brammer MJ, Williams SC, et al. A functional MRI study of working memory task in euthymic bipolar disorder: evidence for task-specific dysfunction. Bipolar Disord. 2004;6:550-564.
70. Ragland JD, Laird AR, Ranganath C, Blumenfeld RS, Gonzales SM, Glahn DC. Prefrontal activation deficits during episodic memory in schizophrenia. Am J Psychiatry. 2009;166:863-874.
71. Townsend J, Bookheimer SY, Foland-Ross LC, Sugar CA, Altshuler LL. fMRI abnormalities in dorsolateral prefrontal cortex during a working memory task in manic, euthymic and depressed bipolar subjects. Psychiatry Res. 2010 Apr;30(182):22-29.
72. Miskowiak K, O'Sullivan U, Harmer CJ. Erythropoietin enhances hippocampal response during memory retrieval in humans. J Neurosci. 2007 Mar; 14(27):2788-2792.
73. Miskowiak K, Inkster B, O'Sullivan U, Selvaraj S, Goodwin GM, Harmer CJ. Differential effects of erythropoietin on neural and cognitive measures of executive function 3 and 7 days post-administration. Exp Brain Res. 2008;184:313-321.
74. Miskowiak KW, Favaron E, Hafizi S, Inkster B, Goodwin GM, Cowen PJ, et al. Effects of erythropoietin on emotional processing biases in patients with major depression: an exploratory fMRI study. Psychopharmacology. 2009;207:133-142.
75. Ramsay IS, MacDonald AW III. Brain correlates of cognitive remediation in schizophrenia: activation likelihood analysis shows preliminary evidence of neural target engagement. Schizophr Bull. 2015;41:1276-1284.
76. Miskowiak KW, Vinberg M, Macoveanu J, Ehrenreich H, Koster N, Inkster B, et al. Effects of erythropoietin on hippocampal volume and memory in mood disorders. Biol Psychiat. 2015;78:270-277.
77. Eack SM, Hogarty GE, Cho RY, Prasad KM, Greenwald DP, Hogarty SS, et al. Neuroprotective effects of cognitive enhancement therapy against gray matter loss in early schizophrenia: results from a 2-year randomized controlled trial. Arch Gen Psychiatry. 2010;67:674-682.
78. Rosenblat JD, Brietzke E, Mansur RB, Maruschak NA, Lee Y, McIntyre RS. Inflammation as a neurobiological substrate of cognitive impairment in bipolar disorder: evidence, pathophysiology and treatment implications. J Affect Disord. 2015;188:149-159.
79. Kessing LV, Andersen PK. Evidence for clinical progression of unipolar and bipolar disorders. Acta Psychiatr Scand. 2017;135:51-64.
80. Grande I, Berk M, Birmaher B, Vieta E. Bipolar disorder. Lancet. 2016;387:1561-1572.
81. Vieta E, Reinares M, Rosa AR. Staging bipolar disorder. Neurotox Res. 2011;19:279-285.
82. Vita A, Deste G, de PL, Barlati S, Poli R, Cesana BM, et al. Predictors of cognitive and functional improvement and normalization after cognitive remediation in patients with schizophrenia. Schizophr Res. 2013;150:51-57.
83. Hassouna I, Ott C, Wustefeld L, Offen N, Neher RA, Mitkovski M, et al. Revisiting adult neurogenesis and the role of erythropoietin for neuronal and oligodendroglial differentiation in the hippocampus. Mol Psychiatry. 2016;21:1752-1767.