Biomarkers in psychotropic drug development: Integration of data across multiple domains

Annual Review of Pharmacology and Toxicology

Volumn 45, Issue , 2005, Pages 227-246

  Bieck, Peter R ^a   Potter, William Z ^b  

^a ELI LILLY AND COMPANY   (United States)

^b NONE

Author keywords

CNS access; CSF; Data integration; Neuroimaging; Proteomics; Psychotropic drug biomarkers

Indexed keywords

2 AMINO 2 (2 CARBOXYCYCLOPROPYL) 3 (XANTHEN 9 YL)PROPIONIC ACID; 5 HYDROXYINDOLEACETIC ACID; APREPITANT; ATOMOXETINE; BIOLOGICAL MARKER; CHOLECYSTOKININ; DULOXETINE; EGLUMETAD; FLUOXETINE; METABOTROPIC RECEPTOR; NEUROKININ 1 RECEPTOR; NISOXETINE; NORADRENALIN; NORADRENALIN TRANSPORTER; PSYCHOTROPIC AGENT; REBOXETINE; SEROTONIN;

BLOOD BRAIN BARRIER; CEREBROSPINAL FLUID; COMPUTER ASSISTED TOMOGRAPHY; DATA ANALYSIS; DEXAMETHASONE SUPPRESSION TEST; DRUG RECEPTOR BINDING; DRUG RESEARCH; ELECTROENCEPHALOGRAM; HUMAN; IMAGE SUBTRACTION; MAGNETOENCEPHALOGRAPHY; NUCLEAR MAGNETIC RESONANCE IMAGING; POSITRON EMISSION TOMOGRAPHY; PRIORITY JOURNAL; PROTEOMICS; PROVOCATION TEST; REVIEW; SINGLE PHOTON EMISSION COMPUTER TOMOGRAPHY; SYSTEMATIC REVIEW;

ANIMALS; BIOLOGICAL MARKERS; HUMANS; PSYCHOTROPIC DRUGS; TECHNOLOGY, PHARMACEUTICAL;

EID: 13844308072     PISSN: 03621642     EISSN: None     Source Type: Book Series    
DOI: 10.1146/annurev.pharmtox.45.120403.095758     Document Type: Review

References (88)

1. Bailey WJ, Ulrich R. 2004. Molecular profiling approaches for identifying novel biomarkers. Expert Opin. Drug Saf. 3:137-51
2. Colburn WA. 2003. Biomarkers in drug discovery and development: from target identification through drug marketing. J. Clin. Pharmacol. 43:329-41
3. Swanson BN. 2002. Delivery of high-quality biomarker assays. Dis. Markers 18:47-56
4. Colburn WA, Lee JW. 2003. Biomarkers, validation and pharmacokinetic- pharmacodynamic modelling. Clin. Pharmacokinet 42:997-1022
5. Niggli E, Egger M. 2004. Applications of multi-photon microscopy in cell physiology. Front. Biosci. 9:1598-610
6. Oertner TG. 2002. Functional imaging of single synapses in brain slices. Exp. Physiol. 87:733-36
7. Rosse RB, Deutsch SI, Deutsch LH. 2000. Medical assessment and laboratory testing in psychiatry. In Kaplan & Sadock's Comprehensive Textbook of Psychiatry, ed. BJ Sadock, VA Sadock. Philadelphia, PA: Lippincott Williams & Wilkins. 750 pp.
8. Weinstein JN. 2001. Searching for pharmacogenomic markers: the synergy between omic and hypothesis-driven research. Dis. Markers 17:77-88
9. Altman RB, Klein TE. 2002. Challenges for biomedical informatics and pharmacogenomics. Annu. Rev. Pharmacol. Toxicol. 42:113-33
10. Klein TE, Altman RB. 2004. PharmGKB: the pharmacogenetics and pharmacogenomics knowledge base. Pharmacogenomics J. 4:1
11. Pardridge WM. 2003. Blood-brain barrier drug targeting: the future of brain drug development. Mol. Intervent. 3:90-105
12. Spector R. 2000. Drug transport in the mammalian central nervous system: multiple complex systems. A critical analysis and commentary. Pharmacology 60:58-73
13. Nau R, Zysk G, Thiel A, Prange HW. 1993. Pharmacokinetic quantification of the exchange of drugs between blood and cerebrospinal fluid in man. Eur. J. Clin. Pharmacol. 45:469-75
14. Cutler NR, Sramek JJ. 1998. Exploratory studies: implications for drug development in Alzheimer's disease. Rev. Neurol. (Paris) 154(Suppl. 2):S131-36
15. Jhee SS, Zarotsky V. 2003. Safety and tolerability of serial cerebrospinal fluid (CSF) collection during pharmacokinetic/pharmacodynamic studies: 5 years of experience. Clin. Res. Regul. Aff. 20: 357-63
16. Zoli M, Jansson A, Sykova E, Agnati LF, Fuxe K. 1999. Volume transmission in the CNS and its relevance for neuropsychopharmacology. Trends Pharmacol. Sci. 20:142-50
17. Duggan AW. 2000. Neuropeptide spread in the brain and spinal cord. Prog. Brain Res. 125:369-80
18. Hoeistad M, Jacobsen K, Olsson A, Brodin E, Hansson H-A, et al. 2003. The cerebrospinal fluid as a migration route for neuropeptides in the rat brain: long-distance migration of beta-endorphin. Presented at Int. Conf. In Vivo Methods, 10th, Karolinska Institutet, Stockholm, Sweden
19. Greitz D, Franck A, Nordell B. 1993. On the pulsatile nature of intracranial and spinal CSF-circulation demonstrated by MR imaging. Acta Radiol. 34:321-28
20. Christensen JD, Yurgelun-Todd DA, Babb SM, Gruber SA, Cohen BM, Renshaw PF. 1999. Measurement of human brain dexfenfluramine concentration by 19F magnetic resonance spectroscopy. Brain Res. 834:1-5
21. Kornhuber J, Schultz A, Wiltfang J, Meineke I, Gleiter CH, et al. 1999. Persistence of haloperidol in human brain tissue. Am. J. Psychiatry 156:885-90
22. Riederer P, Laux G. 1992. Therapeutic drug monitoring of psychotropics: report of a consensus conference. Pharmacopsychiatry 25:271-72
23. Hutchinson PJ, O'Connell MT, Kirkpatrick PJ, Pickard JD. 2002. How can we measure substrate, metabolite and neurotransmitter concentrations in the human brain? Physiol. Meas. 23:R75-109
24. Ahmed S, Mozley PD, Potter WZ. 2002. Biomarkers in psychotropic drug development. Am. J. Geriatr. Psychiatry 10:678-86
25. Wong DF, Potter WZ, Brasic JR. 2002. Proof of concept: functional models for drug development in humans. In Neuropsychopharmacology. The Fifth Generation of Progress, ed. KL Davis, D Charney, JT Coyle, C Nemeroff, pp. 457-73. Philadelphia: Lippincott Williams & Wilkins
26. Marsden CA, Stanford SC. 2000. CNS drugs III: psychotherapeutics. Expert Opin. Investig. Drugs 9:1923-29
27. He QY, Chiu JF. 2003. Proteomics in biomarker discovery and drug development. J. Cell. Biochem. 89:868-86
28. Petricoin EF, Liotta LA. 2004. Clinical proteomics: application at the bedside. Contrib. Nephrol. 141:93-103
29. Rohlff C, Hollis K. 2003. Modern proteomic strategies in the study of complex neuropsychiatric disorders. Biol. Psychiatry 53:847-53
30. Myung JK, Krapfenbauer K, Weitzdoerfer R, Peyrl A, Fountoulakis M, Lubec G. 2003. Expressional pattern of chaperones in neuronal, glial, amnion, mesothelial, and bronchial epithelial cell lines. Mol. Genet. Metab. 80:444-50
31. Peyrl A, Krapfenbauer K, Slave I, Strobel T, Lubec G. 2003. Proteomic characterization of the human cortical neuronal cell line HCN-2. J. Chem. Neuroanat. 26:171-78
32. Tsuji T, Shimohama S. 2001. Analysis of the proteomic profiling of brain tissue in Alzheimer's disease. Dis. Markers 17:247-57
33. Basso M, Giraudo S, Lopiano L, Bergamasco B, Bosticco E, et al. 2003. Proteome analysis of mesencephalic tissues: evidence for Parkinson's disease. Neurol. Sci. 24:155-56
34. Jiang L, Lindpaintner K, Li HF, Gu NF, Langen H, et al. 2003. Proteomic analysis of the cerebrospinal fluid of patients with schizophrenia. Amino Acids 25:49-57
35. Puchades M, Hansson SF, Nilsson CL, Andreasen N, Blennow K, Davidsson P. 2003. Proteomic studies of potential cerebrospinal fluid protein markers for Alzheimer's disease. Brain Res. Mol. Brain Res. 118:140-46
36. Voshol H, Glucksman MJ, van Oostrum J. 2003. Proteomics in the discovery of new therapeutic targets for psychiatric disease. Curr. Mol. Med. 3:447-58
37. You J-S, Gelfanova V, Knierman MD, Witzmann FA, Wang M, Hale JE. 2004. The impact of blood contamination on the proteome of cerebrospinal fluid. Proteomics. In press
38. Reiber H. 1995. External quality assessment in clinical neurochemistry: survey of analysis for cerebrospinal fluid (CSF) proteins based on CSF/serum quotients. Clin. Chem. 41:256-63
39. Reiber H, Thompson EJ, Grimsley G, Bernardi G, Adam P, et al. 2003. Quality assurance for cerebrospinal fluid protein analysis: international consensus by an Internet-based group discussion. Clin. Chem. Lab. Med. 41:331-37
40. Schou M, Halldin C, Sovago J, Pike VW, Gulyas B, et al. 2003. Specific in vivo binding to the norepinephrine transporter demonstrated with the PET radioligand, (S,S)-[11C]MeNER. Nucl. Med. Biol. 30:707-14
41. Bieck PR, Antonin K-H, Schulz R. 1993. Clinical pharmacology of MAO inhibitors. In Monoamine Oxidase: Basic and Clinical Aspects, ed. H Yasuhara, SH Parvez, K Oguchi, M Sandler, T Nagatsu, pp. 177-96. Utrecht: VSP
42. Fowler JS, Logan J, Wang GJ, Franceschi D, Volkow ND, et al. 2003. Monoamine oxidase A imaging in peripheral organs in healthy human subjects. Synapse 49:178-87
43. Fowler JS, Logan J, Volkow ND, Wang GJ, MacGregor RR, Ding YS. 2002. Monoamine oxidase: radiotracer development and human studies. Methods 27: 263-77
44. Robertson D, Flattern N, Tellioglu T, Carson R, Garland E, et al. 2001. Familial orthostatic tachycardia due to norepinephrine transporter deficiency. Ann. NY Acad. Sci. 940:527-43
45. Shannon JR, Flattern NL, Jordan J, Jacob G, Black BK, et al. 2000. Orthostatic intolerance and tachycardia associated with norepinephrine- transporter deficiency. New Engl. J. Med. 342:541-49
46. Vincent S, Bieck PR, Garland EM, Loghin C, Bymaster FP, et al. 2004. Clinical assessment of norepinephrine transporter blockade through biochemical and pharmacologic profile. Circulation 109:3202-7
47. Bymaster FP, Katner JS, Nelson DL, Hemrick-Luecke SK, Threlkeld PG, et al. 2002. Atomoxetine increases extracellular levels of norepinephrine and dopamine in prefrontal cortex of rat: a potential mechanism for efficacy in attention deficit/hyperactivity disorder. Neuropsychopharmacology 27:699-711
48. Shlik J, Aluoja A, Vasar V, Vasar E, Podar T, Bradwejn J. 1997. Effects of citalopram treatment on behavioural, cardiovascular and neuroendocrine response to cholecystokinin tetrapeptide challenge in patients with panic disorder. J. Psychiatry Neurosci. 22:332-40
49. Klein DF. 1993. False suffocation alarms, spontaneous panics, and related conditions. An integrative hypothesis. Arch. Gen. Psychiatry 50:306-17
50. Bell CJ, Malizia AL, Nutt DJ. 1999. The neurobiology of social phobia. Eur. Arch. Psychiatry Clin. Neurosci. 249(Suppl. 1):S11-18
51. Bourin M, Baker GB, Bradwejn J. 1998. Neurobiology of panic disorder. J. Psychosom. Res. 44:163-80
52. Kellner M, Yassouridis A, Hua Y, Wendrich M, Jahn H, Wiedemann K. 2002. Intravenous C-type natriuretic peptide augments behavioral and endocrine effects of cholecystokinin tetrapeptide in healthy men. J. Psychiatr. Res. 36:1-6
53. Wiedemann K, Jahn H, Yassouridis A, Kellner M. 2001. Anxiolyticlike effects of atrial natriuretic peptide on cholecystokinin tetrapeptide-induced panic attacks: preliminary findings. Arch. Gen. Psychiatry 58:371-77
54. Kent JM, Papp LA, Martinez JM, Browne ST, Coplan JD, et al. 2001. Specificity of panic response to CO(2) inhalation in panic disorder: a comparison with major depression and premenstrual dysphoric disorder. Am. J. Psychiatry 158:58-67
55. Bradwejn J, Koszycki D, Annable L, Couetoux du Tertre A, Reines S, Karkanias C. 1992. A dose-ranging study of the behavioral and cardiovascular effects of CCK-tetrapeptide in panic disorder. Biol. Psychiatry 32:903-12
56. Guttmacher LB, Murphy DL, Insel TR. 1983. Pharmacologic models of anxiety. Compr. Psychiatry 24:312-26
57. Bradwejn J, Koszycki D. 1994. Imipramine antagonism of the panicogenic effects of cholecystokinin tetrapeptide in panic disorder patients. Am. J. Psychiatry 151:261-63
58. Zwanzger P, Eser D, Aicher S, Schule C, Baghai TC, et al. 2003. Effects of alprazolam on cholecystokinin-tetrapeptideinduced panic and hypothalamic-pituitary-adrenal-axis activity: a placebo-controlled study. Neuropsychopharmacology 28:979-84
59. Zwanzger P, Baghai TC, Schuele C, Strohle A, Padberg F, et al. 2001. Vigabatrin decreases cholecystokinin-tetrapeptide (CCK-4) induced panic in healthy volunteers. Neuropsychopharmacology 25:699-703
60. Kapur S, Zipursky R, Jones C, Remington G, Houle S. 2000. Relationship between dopamine D(2) occupancy, clinical response, and side effects: a double-blind PET study of first-episode schizophrenia. Am. J. Psychiatry 157:514-20
61. Nyberg S, Eriksson B, Oxenstierna G, Halldin C, Farde L. 1999. Suggested minimal effective dose of risperidone based on PET-measured D2 and 5-HT2A receptor occupancy in schizophrenic patients. Am. J. Psychiatry 156:869-75
62. Mamo D, Sedman E, Tillner J, Sellers EM, Romach MK, Kapur S. 2004. EMD 281014, a specific and potent 5HT(2) antagonist in humans: a dose-finding PET study. Psychopharmacology (Berl.) http://www.springerlink.com/app/home/ contribution.asp?wasp=3201v1yq1q4u1y 32wmf0&referrer=parent&backto= issue, 149,162;journal,1,183;linkingpublication results,1:100390
63. Lemberger L, Rowe H, Carmichael R, Oldham S, Horng JS, et al. 1978. Pharmacologic effects in man of a specific serotonin-reuptake inhibitor. Science 199:436-37
64. Bymaster FP, Zhang W, Carter PA, Shaw J, Chemet E, et al. 2002. Fluoxetine, but not other selective serotonin uptake inhibitors, increases norepinephrine and dopamine extracellular levels in prefrontal cortex. Psychopharmacology (Berl.) 160:353-61
65. Martensson B, Nyberg S, Toresson G, Brodin E, Bertilsson L. 1989. Fluoxetine treatment of depression. Clinical effects, drug concentrations and monoamine metabolites and N-terminally extended substance P in cerebrospinal fluid. Acta Psychiatr. Scand. 79:586-96
66. Karson CN, Newton JE, Livingston R, JoUy JB, Cooper TB, et al. 1993. Human brain fluoxetine concentrations. J. Neuropsychiatry Clin. Neurosci. 5:322-29
67. Mayberg HS, Brannan SK, Tekell JL, Silva JA, Mahurin RK, et al. 2000. Regional metabolic effects of fluoxetine in major depression: serial changes and relationship to clinical response. Biol. Psychiatry 48:830-43
68. Owens MJ, Morgan WN, Plott SJ, Nemeroff CB. 1997. Neurotransmitter receptor and transporter binding profile of antidepressants and their metabolites. J. Pharmacol. Exp. Ther. 283:1305-22
69. Henry ME, Kaufman MJ, Hennen J, Michelson D, Schmidt ME, et al. 2003. Cerebral blood volume and clinical changes on the third day of placebo substitution for SSRI treatment. Biol. Psychiatry 53:100-5
70. Mutel V, Adam G, Chaboz S, Kemp JA, Klingelschmidt A, et al. 1998. Characterization of (2S,2′R,3′R)-2-(2′,3′-[3H]- dicarboxycyclopropyl)glycine binding in rat brain. J. Neurochem. 71:2558-64
71. Bieck PR, Geracioti TD, D'Souza B, Ledent E, Perkins EJ, et al. 2002. Penetration of orally administered LY354740 into the human CSF. Int. J. Neuropsychopharmacology 5(Suppl. 1):S150
72. Bieck PR, Jhee SS, Ledent E, Mackie AE, Patil S, et al. 2003. Application of continuous cerebro spinal fluid (CSF) collection in man to assess the glutamate receptor antagonist LY354740 pharmacokinetics and its effect on biomarker and proteomics. Presented at Monitoring Molecules in Neuroscience, Int. Conf. on In Vivo Methods, 10th, Stockholm, Sweden
73. Schoepp DD, Wright RA, Levine LR, Gaydos B, Potter WZ. 2003. LY354740, an mGlu2/3 receptor agonist as a novel approach to treat anxiety/stress. Stress 6:189-97
74. Kellner M, Muhtz C, Yassouridis A, Stark K, Arlt J, et al. 2004. Effects of the metabotropic glutamate type II agonist LY544344 on panic and anxiety induced by cholecystokinin tetrapeptide (CCK4). Int. J. Neuropsychopharmacol. 7:S369
75. Van Belle S, Lichinitser MR, Navari RM, Garin AM, Decramer ML, et al. 2002. Prevention of cisplatin-induced acute and delayed emesis by the selective neurokinin-1 antagonists, L-758,298 and MK-869. Cancer 94:3032-41
76. Campos D, Pereira JR, Reinhardt RR, Carracedo C, Poli S, et al. 2001. Prevention of cisplatin-induced emesis by the oral neurokinin-1 antagonist, MK-869, in combination with granisetron and dexamethasone or with dexamethasone alone. J. Clin. Oncol. 19:1759-67
77. Hargreaves R. 2002. Imaging substance P receptors (NK 1) in the living human brain using positron emission tomography. J. Clin. Psychiatry 63(Suppl. 11):18-24
78. Bergstrom M, Hargreaves RJ, Burns DH, Goldberg MR, Sciberras D, et al. 2004. Human positron emission tomography studies of brain neurokinin 1 receptor occupancy by aprepitant. Biol. Psychiatry 55:1007-12
79. Chawla SP, Grunberg SM, Gralla RJ, Hesketh PJ, Rittenberg C, et al. 2003. Establishing the dose of the oral NK1 antagonist aprepitant for the prevention of chemotherapy-induced nausea and vomiting. Cancer 97:2290-300
80. Ranga K, Krishnan R. 2002. Clinical experience with substance P receptor (NK1) antagonists in depression. J. Clin. Psychiatry 63(Suppl. 11):25-29
81. Helton DR, Tizzano JP, Monn JA, Schoepp DD, Kallman MJ. 1998. Anxiolytic and side-effect profile of LY354740: a potent, highly selective, orally active agonist for group II metabotropic glutamate receptors. J. Pharmacol. Exp. Ther. 284:651-60
82. Schoepp DD, Johnson BG, Wright RA, Salhoff CR, Mayne NG, et al. 1997. LY354740 is a potent and highly selective group II metabotropic glutamate receptor agonist in cells expressing human glutamate receptors. Neuropharmacology 36:1-11
83. Frank R, Hargreaves R. 2003. Clinical biomarkers in drug discovery and development. Nat. Rev. Drug Discov. 2:566-80
84. Wong ML, Licinio J. 2004. From monoamines to genomic targets: a paradigm shift for drug discovery in depression. Nat. Rev. Drug Discov. 3:136-51
85. Weber DA, Ivanovic M. 1999. Ultrahigh-resolution imaging of small animals: implications for preclinical and research studies. J. Nucl Cardiol 6:332-44
86. Acton PD, Choi SR, Plossl K, Kung HF. 2002. Quantification of dopamine transporters in the mouse brain using ultra-high resolution single-photon emission tomography. Eur. J. Nucl. Med. Mol. Imaging 29:691-98
87. De Gruttola VG, Clax P, DeMets DL, Downing GJ, Ellenberg SS, et al. 2001. Considerations in the evaluation of surrogate endpoints in clinical trials. Summary of a National Institutes of Health workshop. Control. Clin. Trials 22:485-502
88. Report W. 2002. Defining the Mandate Of Proteomics in the Post-Genomics Era. Washington, DC: The Natl. Acad. Press