Rationale and design of the participant, investigator, observer, and data-analyst-blinded randomized AGENDA trial on associations between gene-polymorphisms, endophenotypes for depression and antidepressive intervention: The effect of escitalopram versus placebo on the combined dexamethasone-corticotrophine releasing hormone test and other potential endophenotypes in healthy first-degree relatives

Trials

Volumn 10, Issue , 2009, Pages

  Knorr, Ulla ^a   Vinberg, Maj ^a   Klose, Marianne ^a   Feldt Rasmussen, Ulla ^a   Hilsted, Linda ^a   Gade, Anders ^b   Haastrup, Eva ^c   Paulson, Olaf ^a,d,e   Wetterslev, Jørn ^c   Gluud, Christian ^c   Gether, Ulrik ^b   Kessing, Lars ^a  

^a Rigshospitalet   (Denmark)

^b UNIVERSITY OF COPENHAGEN   (Denmark)

^c Mental Health Services CPH   (Denmark)

^d HVIDOVRE HOSPITAL   (Denmark)

^e Center for Integrated Molecular Brain Imaging   (Denmark)

Author keywords

[No Author keywords available]

Indexed keywords

CORTICOTROPIN; DEXAMETHASONE; ESCITALOPRAM; HYDROCORTISONE; PLACEBO; ANTIDEPRESSANT AGENT; CITALOPRAM; CORTICOTROPIN RELEASING FACTOR; DIAGNOSTIC AGENT;

ADULT; ARTICLE; CLINICAL TRIAL; COGNITION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEPRESSION; DNA POLYMORPHISM; DOUBLE BLIND PROCEDURE; ENDOPHENOTYPE; EVENING DOSAGE; FEMALE; GENOTYPE; HUMAN; HYDROCORTISONE BLOOD LEVEL; HYPOTHALAMUS HYPOPHYSIS SYSTEM; MAJOR CLINICAL STUDY; MALE; NEUROSIS; OUTCOME ASSESSMENT; PERSONALITY; PHENOTYPE; RANDOMIZED CONTROLLED TRIAL; SELF MEDICATION; SINGLE DRUG DOSE; TREATMENT DURATION; ADOLESCENT; COMPARATIVE STUDY; GENETICS; METHODOLOGY; MIDDLE AGED; STATISTICS;

ADOLESCENT; ADULT; ANTIDEPRESSIVE AGENTS, SECOND-GENERATION; CITALOPRAM; CORTICOTROPIN-RELEASING HORMONE; DEPRESSIVE DISORDER; DEXAMETHASONE; FEMALE; HUMANS; MALE; MIDDLE AGED; PHENOTYPE; RESEARCH DESIGN; STATISTICS AS TOPIC;

EID: 69749088328     PISSN: 17456215     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-10-66     Document Type: Article

References (75)

1. Robins E Guze SB Establishment of diagnostic validity in psychiatric illness: Its application to schizophrenia Am J Psychiatry 1970, 126:983-987. 5409569
2. Kendell RE Clinical validity Psychol Med 1989, 19:45-55. 10.1017/ S0033291700011016 2657832
3. Gould TD Gottesman II Psychiatric endophenotypes and the development of valid animal models Genes Brain Behav 2006, 5;113-119. 10.1111/ j.1601-183X.2005.00186.x 16507002
4. Hasler G Drevets WC Gould TD Gottesman II Manji HK Toward constructing an endophenotype strategy for bipolar disorders Biol Psychiatry 2006, 60:93-105. 10.1016/j.biopsych.2005.11.006 16406007
5. Holsboer F The corticosteroid receptor hypothesis of depression Neuropsychopharmacology 2000, 23:477-501. 10.1016/S0893-133X(00)00159-7 11027914
6. Pariante CM Papadopoulos AS Poon L Cleare AJ Checkley SA English J et al Four days of citalopram increase suppression of cortisol secretion by prednisolone in healthy volunteers Psychopharmacology (Berl) 2004, 177:200-206. 10.1007/s00213-004-1925-4 15179544
7. Raison CL Miller AH When not enough is too much: The role of insufficient glucocorticoid signaling in the pathophysiology of stress-related disorders Am J Psychiatry 2003, 160:1554-1565. 10.1176/ appi.ajp.160.9.1554 12944327
8. Ising M Kunzel HE Binder EB Nickel T Modell S Holsboer F The combined dexamethasone/CRH test as a potential surrogate marker in depression Prog Neuropsychopharmacol Biol Psychiatry 2005, 29:1085-1093. 10.1016/ j.pnpbp.2005.03.014 15950349
9. Modell S Lauer CJ Schreiber W Huber J Krieg JC Holsboer F Hormonal response pattern in the combined DEX-CRH test is stable over time in subjects at high familial risk for affective disorders Neuropsychopharmacology 1998, 18:253-262. 10.1016/S0893-133X(97)00144-9 9509493
10. Ising M Horstmann S Kloiber S Lucae S Binder EB Kern N et al Combined dexamethasone/corticotropin releasing hormone test predicts treatment response in major depression - a potential biomarker? Biol Psychiatry 2007, 62:47-54. 10.1016/j.biopsych.2006.07.039 17123470
11. Ravnkilde B Videbech P Clemmensen K Egander A Rasmussen NA Rosenberg R Cognitive deficits in major depression Scand J Psychol 2002, 43:239-251. 10.1111/1467-9450.00292 12184479
12. Paelecke-Habermann Y Pohl J Leplow B Attention and executive functions in remitted major depression patients J Affect Disord 2005, 89:125-135. 10.1016/j.jad.2005.09.006 16324752
13. Weiland-Fiedler P Erickson K Waldeck T Luckenbaugh DA Pike D Bonne O et al Evidence for continuing neuropsychological impairments in depression J Affect Disord 2004, 82:253-258. 10.1016/j.jad.2003.10.009 15488254
14. Kessing LV Cognitive impairment in the euthymic phase of affective disorder Psychol Med 1998, 28:1027-1038. 10.1017/S0033291798006862 9794010
15. Clark L Sarna A Goodwin GM Impairment of executive function but not memory in first-degree relatives of patients with bipolar I disorder and in euthymic patients with unipolar depression Am J Psychiatry 2005, 162:1980-1982. 10.1176/appi.ajp.162.10.1980 16199852
16. Savitz JB Solms M Ramesar RS Neurocognitive function as an endophenotype for genetic studies of bipolar affective disorder Neuromolecular Med 2005, 7:275-286. 10.1385/NMM:7:4:275 16391385
17. Christensen MV Kyvik KO Kessing LV Cognitive function in unaffected twins discordant for affective disorder Psychol Med 2006, 36:1119-1129. 10.1017/S0033291706007896 16734950
18. Eysenck HJ Eysenck SGB The Manual of the Eysenck Personality Questionnaie London: Hodder and Stoughton 1975.
19. Costa PT Jr McCrae RR Stability and change in personality assessment: the revised NEO Personality Inventory in the year 2000 J Pers Assess 1997, 68:86-94. 10.1207/s15327752jpa6801_7 9018844
20. Kirk KM Birley AJ Statham DJ Haddon B Lake RI Andrews JG et al Anxiety and depression in twin and sib pairs extremely discordant and concordant for neuroticism: Prodromus to a linkage study Twin Res 2000, 3;299-309. 10.1375/136905200320565274 11463151
21. Vinberg M Mortensen EL Kyvik KO Kessing LV Personality traits in unaffected twins discordant for affective disorder Acta Psychiatr Scand 2007, 115:442-450. 10.1111/j.1600-0447.2006.00909.x 17498155
22. Hasler G Drevets WC Manji HK Charney DS Discovering endophenotypes for major depression Neuropsychopharmacology 2004, 29:1765-1781. 10.1038/ sj.npp.1300506 15213704
23. Krieg JC Lauer CJ Schreiber W Modell S Holsboer F Neuroendocrine, polysomnographic and psychometric observations in healthy subjects at high familial risk for affective disorders: The current state of the 'Munich vulnerability study' J Affect Disord 2001, 62:33-37. 10.1016/ S0165-0327(00)00348-7 11172871
24. Holsboer-Trachsler E Stohler R Hatzinger M Repeated administration of the combined dexamethasone-human corticotropin releasing hormone stimulation test during treatment of depression Psychiatry Res 1991, 38:163-171. 10.1016/0165-1781(91)90041-M 1661430
25. Binder EB Kunzel HE Nickel T Kern N Pfennig A Majer M HPA-axis regulation at in-patient admission is associated with antidepressant therapy outcome in male but not in female depressed patients Psychoneuroendocrinology 2009, 34:99-109. 10.1016/j.psyneuen.2008.08.018 18829172
26. Burt DB Zembar MJ Niederehe G Depression and memory impairment: A meta-analysis of the association, its pattern, and specificity Psychol Bull 1995, 117:285-305. 10.1037/0033-2909.117.2.285 7724692
27. Quilty LC Meusel LA Bagby RM Neuroticism as a mediator of treatment response to SSRIs in major depressive disorder J Affect Disord 2008, 111:67-73. 10.1016/j.jad.2008.02.006 18384882
28. Tse WS Bond AJ Serotonergic intervention affects both social dominance and affiliative behaviour Psychopharmacology (Berl) 2002, 161:324-330. 10.1007/s00213-002-1049-7 12021836
29. Knutson B Wolkowitz OM Cole SW Chan T Moore EA Johnson RC et al Selective alteration of personality and social behavior by serotonergic intervention Am J Psychiatry 1998, 155:373-379. 9501748
30. Gelfin Y Gorfine M Lerer B Effect of clinical doses of fluoxetine on psychological variables in healthy volunteers Am J Psychiatry 1998, 155:290-292. 9464215
31. Kato M Serretti A Review and meta-analysis of antidepressant pharmacogenetic findings in major depressive disorder Mol Psychiatry 2008. 18982004
32. Bock C Bukh JD Vinberg M Gether U Kessing LV Do stressful life events predict medical treatment outcome in first episode of depression? Soc Psychiatry Psychiatr Epidemiol 2009. 19209372
33. Owens MJ Knight DL Nemeroff CB Second-generation SSRIs: Human monoamine transporter binding profile of escitalopram and R-fluoxetine Biol Psychiatry 2001, 50:345-350. 10.1016/S0006-3223(01)01145-3 11543737
34. Cipriani A Furukawa TA Salanti G Geddes JR Higgins JP Churchill R et al Comparative efficacy and acceptability of 12 new-generation antidepressants: A multiple-treatments meta-analysis Lancet 2009, 373:746-58. 10.1016/S0140-6736(09)60046-5 19185342
35. Wood L Egger M Gluud LL Schulz KF Juni P Altman DG et al Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: Meta-epidemiological study BMJ 2008, 336:601-605. 10.1136/bmj.39465.451748.AD 2267990 18316340
36. Mossner R Mikova O Koutsilieri E Saoud M Ehlis AC Muller N et al Consensus paper of the WFSBP Task Force on Biological Markers: biological markers in depression World J Biol Psychiatry 2007, 8:141-174. 10.1080/15622970701263303 17654407
37. Nelson HE O'Connell A Dementia: The estimation of premorbid intelligence levels using the New Adult Reading Test Cortex 1978, 14:234-244. 679704
38. Waldemar G Bruhn P Kristensen M Johnsen A Paulson OB Lassen NA Heterogeneity of neocortical cerebral blood flow deficits in dementia of the Alzheimer type: A [99mTc]-d, l-HMPAO SPECT study J Neurol Neurosurg Psychiatry 1994, 57:285-295. 10.1136/jnnp.57.3.285 1072816 8158175
39. Reitan RM Trail Making Test. Manual for Administration and Scoring 2920 South 4th Avenue, South Tucson, Arizona 85713-4819, Reitan Neuropsychology Laboratory 1992
40. Kaplan E Goodglass H Weintraub S Boston Naming Test, Philadelphia 2, 1983.
41. Gade A Mortensen EL Bruhn P "Chronic painter's syndrome". A reanalysis of psychological test data in a group of diagnosed cases, based on comparisons with matched controls Acta Neurol Scand 1988, 77:293-306. 10.1111/j.1600-0404.1988.tb05913.x 3389080
42. Buschke H Sliwinski MJ Kuslansky G Lipton RB Diagnosis of early dementia by the Double Memory Test: Encoding specificity improves diagnostic sensitivity and specificity Neurology 1997, 48:989-997. 9109889
43. Roth M Tym E Mountjoy CQ Huppert FA Hendrie H Verma S et al CAMDEX. A standardised instrument for the diagnosis of mental disorder in the elderly with special reference to the early detection of dementia Br J Psychiatry 1986, 149:698-709. 10.1192/bjp.149.6.698 3790869
44. Hawkins KA Dean D Pearlson GD Alternative forms of the Rey Auditory Verbal Learning Test: A review Behav Neurol 2004, 15:99-107. 15706053
45. Akshoofmoff N Stiles J Developmental trends in visuospatial analysis and planning: Copying a complex figure Neuropsychology 1995, 9:364-377. 10.1037/0894-4105.9.3.364
46. Yaretsky A Arzi T Ben-Nun Y Word fluency in aging and dementia: principles of relatedness in the generative naming process Arch Gerontol Geriatr 1999, 29:57-60. 10.1016/S0167-4943(99)00023-0 15374077
47. Sheridan LK Fitzgerald HE Adams KM Nigg JT Martel MM Puttler LI et al Normative Symbol Digit Modalities Test performance in a community-based sample Arch Clin Neuropsychol 2006, 21:23-28. 10.1016/j.acn.2005.07.003 16139470
48. Bechara A Damasio H Tranel D Damasio AR The Iowa Gambling Task and the somatic marker hypothesis: Some questions and answers Trends Cogn Sci 2005, 9:159-162. 10.1016/j.tics.2005.02.002 15808493
49. Haut MW Kuwabara H Leach S Arias RG Neural activation during performance of number-letter sequencing Appl Neuropsychol 2000, 7:237-242. 10.1207/ S15324826AN0704_5 11296686
50. Donais P O'Sullivan and Guilford's Four Factor Test of Social Intelligence as predictors of counselor effectiveness: An exploratory study Dissertation Abstacts International 2006, 40:3115.
51. Mendez MF Anderson E Shapira JS An investigation of moral judgement in frontotemporal dementia Cogn Behav Neurol 2005, 18:193-197. 10.1097/ 01.wnn.0000191292.17964.bb 16340391
52. Greene JD Sommerville RB Nystrom LE Darley JM Cohen JD An fMRI investigation of emotional engagement in moral judgment Science 2001, 293:2105-2108. 10.1126/science.1062872 11557895
53. Lopes PN Brackett MA Nezlek JB Schutz A Sellin I Salovey P Emotional intelligence and social interaction Pers Soc Psychol Bull 2004, 30:1018-1034. 10.1177/0146167204264762 15257786
54. Sprengelmeyer R Young AW Calder AJ Karnat A Lange H Homberg V et al Loss of disgust. Perception of faces and emotions in Huntington's disease Brain 1996, 119(Pt 5):1647-1665. 10.1093/brain/119.5.1647 8931587
55. Hamilton M A rating scale for depression J Neurol Neurosurg Psychiatry 1960, 23:56-62. 10.1136/jnnp.23.1.56 495331 14399272
56. Hamilton M The assessment of anxiety states by rating Br J Med Psychol 1959, 32:50-55. 13638508
57. Klepstad P Loge JH Borchgrevink PC Mendoza TR Cleeland CS Kaasa S The Norwegian brief pain inventory questionnaire: Translation and validation in cancer pain patients J Pain Symptom Manage 2002, 24:517-525. 10.1016/ S0885-3924(02)00526-2 12547051
58. Buss AH Perry M The aggression questionnaire J Pers Soc Psychol 1992, 63:452-459. 10.1037/0022-3514.63.3.452 1403624
59. Beck AT Ward CH Mendelson M Mock J Erbaugh J An inventory for measuring depression Arch Gen Psychiatry 1961, 4:561-571. 13688369
60. Skevington SM Lotfy M O'Connell KA The World Health Organization's WHOQOL-BREF quality of life assessment: Psychometric properties and results of the international field trial. A report from the WHOQOL group Qual Life Res 2004, 13;299-310. 10.1023/B:QURE.0000018486.91360.00 15085902
61. Cohen S Kamarck T Mermelstein R A global measure of perceived stress J Health Soc Behav 1983, 24:385-396. 10.2307/2136404 6668417
62. Deshauer D Duffy A Meaney M Sharma S Grof P Salivary cortisol secretion in remitted bipolar patients and offspring of bipolar parents Bipolar Disord 2006, 8:345-349. 10.1111/j.1399-5618.2006.00338.x 16879135
63. Lindstrom E Lewander T Malm U Malt UF Lublin H Ahlfors UG Patient-rated versus clinician-rated side effects of drug treatment in schizophrenia. Clinical validation of a self-rating version of the UKU Side Effect Rating Scale (UKU-SERS-Pat) Nord J Psychiatry 2001, 55(Suppl 44):5-69. 11860666
64. Wing JK Babor T Brugha T Burke J Cooper JE Giel R et al. SCAN. Schedules for Clinical Assessment in Neuropsychiatry Arch Gen Psychiatry 1990, 47:589-593. 2190539
65. Vickers AJ Altman DG Statistics notes: Analysing controlled trials with baseline and follow up measurements BMJ 2001, 323:1123-1124. 10.1136/ bmj.323.7321.1123 1121605 11701584
66. ICH Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/ 135/95) 2006. http://www.emea.europa.eu/pdfs/human/ich/013595en.pdf
67. Moher D Schulz KF Altman D The CONSORT Statement: Revised recommendations for improving the quality of reports of parallel-group randomized trials 2001 Explore (NY) 2005, 1:40-45. 16791967
68. Videbech P Ravnkilde B Hippocampal volume and depression: A meta-analysis of MRI studies Am J Psychiatry 2004, 161:1957-1966. 10.1176/appi.ajp.161.11.1957 15514393
69. Gorno-Tempini ML Pradelli S Serafini M Pagnoni G Baraldi P Porro C et al Explicit and incidental facial expression processing: An fMRI study Neuroimage 2001, 14:465-473. 10.1006/nimg.2001.0811 11467919
70. Vollm B Richardson P McKie S Elliott R Deakin JF Anderson IM Serotonergic modulation of neuronal responses to behavioural inhibition and reinforcing stimuli: An fMRI study in healthy volunteers Eur J Neurosci 2006, 23:552-560. 10.1111/j.1460-9568.2005.04571.x 16420462
71. Kendler KS Kessler RC Walters EE MacLean C Neale MC Heath AC et al Stressful life events, genetic liability, and onset of an episode of major depression in women Am J Psychiatry 1995, 152:833-842. 7755111
72. The Structured Clinical Interview for DSM - IV Axis II Personality Disorders (SCID - II) Wasington DC: American Psychiatric Press 1997.
73. Oldfield RC The assessment and analysis of handedness: The Edinburgh inventory Neuropsychologia 1971, 9:97-113. 10.1016/0028-3932(71)90067-4 5146491
74. Golden CJFS Stroop Color an Word Test, revised 2002 adult Manual for Clincal and Experimental Uses. Stoelting 2002.
75. Norholm V Bech P The WHO Quality of Life (WHOQOL) Questionnaire: Danish validation study Nord J Psychiatry 2001, 55:229-235. 10.1080/ 080394801681019075 11839112