A randomised, double-blind, placebo-controlled trial of tropisetron in patients with schizophrenia

Annals of General Psychiatry

Volumn 9, Issue , 2010, Pages

  Shiina, Akihiro ^a   Shirayama, Yukihiko ^b   Niitsu, Tomihisa ^c   Hashimoto, Tasuku ^c   Yoshida, Taisuke ^c   Hasegawa, Tadashi ^a   Haraguchi, Tadashi ^c   Kanahara, Nobuhisa ^c   Shiraishi, Tetsuya ^c   Fujisaki, Mihisa ^a   Fukami, Goro ^a   Nakazato, Michiko ^a   Iyo, Masaomi ^a,c   Hashimoto, Kenji ^d  

^a CHIBA UNIVERSITY HOSPITAL   (Japan)

^b TEIKYO UNIVERSITY CHIBA MEDICAL CENTER   (Japan)

^c CHIBA UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^d CHIBA UNIVERSITY   (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

BENZODIAZEPINE; BIPERIDEN; CARBAMAZEPINE; LITHIUM; MILNACIPRAN; PLACEBO; RISPERIDONE; TRAZODONE; TRIHEXYPHENIDYL; TROPISETRON; VALPROIC ACID;

ADJUVANT THERAPY; ADULT; ARTICLE; ATTENTION; CLINICAL ARTICLE; CLINICAL TRIAL; COGNITIVE DEFECT; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE DURATION; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG DOSE TITRATION; DRUG EFFECT; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ELECTROCARDIOGRAM; FEMALE; HEARING; HUMAN; INTELLIGENCE QUOTIENT; MALE; MENTAL PATIENT; PATIENT COMPLIANCE; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; SCHIZOPHRENIA; SENSORY GATING; SIDE EFFECT; THORAX PAIN; VISION;

EID: 77954611225     PISSN: None     EISSN: 1744859X     Source Type: Journal    
DOI: 10.1186/1744-859X-9-27     Document Type: Article

References (55)

1. Green M. What are the functional consequences of neurocognitive deficits in schizophrenia?. Am J Psychiatry 1996, 153:321-330.
2. Harvey PD, Keefe RS. Studies of cognitive change in patients with schizophrenia following novel antipsychotic treatment. Am J Psychiatry 2001, 158:176-184. 10.1176/appi.ajp.158.2.176, 11156796.
3. Green MF, Nuechterlein KH, Gold JM, Barch DM, Cohen J, Essock S, Fenton WS, Frese F, Goldberg TE, Heaton RK, Keefe RS, Kern RS, Kraemer H, Stover E, Weinberger DR, Zalcman S, Marder SR. Approaching a consensus cognitive battery for clinical trials in schizophrenia: the NIMH-MATRICS conference to select cognitive domains and test criteria. Biol Psychiatry 2004, 56:301-307. 10.1016/j.biopsych.2004.06.023, 15336511.
4. Green MF, Kern RS, Heaton RK. Longitudinal studies of cognition and functional outcome in schizophrenia: implications for MATRICS. Schizophrenia Res 2004, 72:41-51.
5. Harvey PD, Helldin L, Bowie CR, Heaton RK, Olsson AK, Hjärthag F, Norlander T, Patterson TL. Performance-based measurement of functional disability in schizophrenia: a cross-national study in the United States and Sweden. Am J Psychiatry 2009, 166:821-827. 10.1176/appi.ajp.2009.09010106, 19487393.
6. Meltzer HY, McGurk SR. The effects of clozapine, risperidone, and olanzapine on cognitive function in schizophrenia. Schizophrenia Bull 1999, 25:233-255.
7. Freedman R, Adler LE, Bickford P, Byerley W, Coon H, Cullum CM, Griffith J, Harris JG, Leonard S, Miller C, Myles-Worsey M, Nagamoto HT, Rose G, Waldo M. Schizophrenia and nicotinic receptors. Harv Rev Psychiatry 1994, 2:179-192. 10.3109/10673229409017136, 9384901.
8. Freedman R, Coon H, Myles-Worsley M, Orr-Urtreger A, Olincy A, Davis A, Polymeropoulos M, Holik J, Hopkins J, Hoff M, Rosenthal J, Waldo MC, Reimherr F, Wender P, Yaw J, Young DA, Breese CR, Adams C, Patterson D, Adler LE, Kruglyak L, Leonard S, Byerley W. Linkage of a neurophysiological deficit in schizophrenia to a chromosome 15 locus. Proc Natl Acad Sci USA 1997, 94:587-592. 10.1073/pnas.94.2.587, 19557, 9012828.
9. Leonard S, Gault J, Hopkins J, Logel J, Vianzon R, Short M, Drebing C, Berger R, Venn D, Sirota P, Zerbe G, Olincy A, Ross RG, Adler LE, Freedman R. Association of promoter variants in the α7 nicotinic acetylcholine receptor subunit gene with an inhibitory deficit found in schizophrenia. Arch Gen Psychiatry 2002, 59:1085-1096. 10.1001/archpsyc.59.12.1085, 12470124.
10. Leonard S, Freedman R. Genetics of chromosome 15q13-q14 in schizophrenia. Biol Psychiatry 2006, 60:115-122. 10.1016/j.biopsych.2006.03.054, 16843094.
11. Martin LF, Kem WR, Freedman R. α7 nicotinic receptor agonists: potential new candidates for the treatment of schizophrenia. Psychopharmacology (Berlin) 2004, 174:54-64.
12. Hashimoto K, Koike K, Shimizu E, Iyo M. α7 Nicotinic receptor agonists as potential therapeutic drugs for schizophrenia. Curr Med Chem CNS Agents 2005, 5:171-184.
13. Olincy A, Harris JG, Johnson LL, Pender V, Kongs S, Allensworth D, Ellis J, Zerbe GO, Leonard S, Stevens KE, Stevens JO, Martin L, Adler LE, Soti F, Kem WR, Freedman R. Proof-of-concept trial of an α7 nicotinic agonist in schizophrenia. Arch Gen Psychiatry 2006, 63:630-638. 10.1001/archpsyc.63.6.630, 16754836.
14. Freedman R, Olincy A, Buchanan RW, Harris JG, Gold JM, Johnson L, Allensworth D, Guzman-Bonilla A, Clement B, Ball MP, Kutnick J, Pender V, Martin LF, Stevens KE, Wagner BD, Zerbe GO, Soti F, Kem WR. Initial phase 2 trial of a nicotinic agonist in schizophrenia. Am J Psychiatry 2008, 165:1040-1047. 10.1176/appi.ajp.2008.07071135, 18381905.
15. Buchanan RW, Freedman R, Javitt DC, Abi-Dargham A, Lieberman JA. Recent advances in the development of novel pharmacological agents for the treatment of cognitive impairments in schizophrenia. Schizophrenia Bull 2007, 33:1120-1130.
16. Olincy A, Stevens KE. Treating schizophrenia symptoms with an α7 nicotinic agonist, from mice to men. Biochem Pharmacol 2007, 74:1192-1201. 10.1016/j.bcp.2007.07.015, 2134979, 17714692.
17. Toyohara J, Hashimoto K. α7 Nicotinic receptor agonists as potential therapeutic drugs for treatment of cognitive dysfunction associated with Alzheimer's disease and schizophrenia. Open Med Chem J 2010, 4:37-56.
18. Simpson K, Spencer CM, McClellan KJ. Tropisetron: an update of its use in the prevention of chemotherapy-induced nausea and vomiting. Drugs 2000, 59:1297-1315. 10.2165/00003495-200059060-00008, 10882164.
19. Macor JE, Gurley D, Lanthorn T, Loch J, Mack RA, Mullen G, Tran O, Wright N, Gordon JC. The 5-HT3 antagonist tropisetron (ICS 205-930) is a potent and selective α7 nicotinic receptor partial agonist. Bioorg Med Chem Lett 2001, 11:319-321. 10.1016/S0960-894X(00)00670-3, 11212100.
20. Hashimoto K, Iyo M, Freedman R, Stevens KE. Tropisetron improves deficient inhibitory auditory processing in DBA/2 mice: role of α7 nicotinic acetylcholine receptors. Psychopharmacology (Berlin) 2005, 183:13-19.
21. Hashimoto K, Fujita Y, Ishima T, Hagiwara H, Iyo M. Phencyclidine-induced cognitive deficits in mice are improved by subsequent subchronic administration of tropisetron: role of α7 nicotinic receptors. Eur J Pharmacol 2006, 553:191-195. 10.1016/j.ejphar.2006.09.055, 17094961.
22. Hashimoto K, Ishima T, Fujita Y, Matsuo M, Kobashi T, Takahagi M, Tsukada H, Iyo M. Phencyclidine-induced cognitive deficits in mice are improved by subsequent subchronic administration of the novel selective a7 nicotinic receptor agonist SSR180711. Biol Psychiatry 2008, 63:92-97. 10.1016/j.biopsych.2007.04.034, 17601496.
23. Koike K, Hashimoto K, Takai N, Shimizu E, Komatsu N, Watanabe H, Nakazato M, Okamura N, Stevens KE, Freedman R, Iyo M. Tropisetron improves deficits in auditory P50 suppression in schizophrenia. Schizophrenia Res 2005, 76:67-72.
24. Cullum CM, Harris JG, Waldo MC, Smernoff E, Madison A, Nagamoto HT, Griffith J, Adler LE, Freedman R. Neurophysiological and neuropsychological evidence for attentional dysfunction in schizophrenia. Schizophrenia Res 1993, 10:131-141.
25. American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV-TR 2000, Arlington, VA, USA: American Psychiatric Press, American Psychiatric Association.
26. Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia Evaluation and diagnosis of drug-induced extrapyramidal symptoms: commentary on the DIEPSS and guide to its usage [in Japanese]. Schizophrenia Bull 1987, 13:261-276.
27. Inada T. Evaluation and diagnosis of drug-induced extrapyramidal symptoms: commentary on the DIEPSS and guide to its usage [in Japanese] 1996, Tokyo, Japan: Seiwa.
28. Heinrichs DW, Hanlon TE, Carpenter WT. The Quality of Life Scale: an instrument for rating the schizophrenia deficits syndrome. Schizophrenia Bull 1984, 10:388-398.
29. Sahakian BJ, Owen AM. Computerized assessment in neuropsychiatry using CANTAB: discussion paper. J R Soc Med 1992, 85:399-402. 1293547, 1629849.
30. Fray PJ, Robbins TW, Sahakian BJ. Neuropsychiatric applications of CANTAB. Int J Ger Psychiatry 1996, 11:329-336.
31. Levaux MN, Potvin S, Sepehry AA, Sablier J, Mendrek A, Stip E. Computerized assessment of cognition in schizophrenia: promises and pitfalls of CANTAB. Eur Psychiatry 2007, 22:104-115. 10.1016/j.eurpsy.2006.11.004, 17227707.
32. Clementz BA, Geyer MA, Braff DL. Poor P50 suppression among schizophrenia patients and their first-degree biological relatives. Am J Psychiatry 1998, 155:1691-1694.
33. Adler LE, Hoffer LD, Wiser A, Freedman R. Normalization of auditory physiology by cigarette smoking in schizophrenic patients. Am J Psychiatry 1993, 150:1856-1861.
34. George TP, Vessicchio JC, Termine A, Sahady D, Head CA, Pepper T, Kosten TR, Wexler BE. Effects of smoking abstinence on visuospatial working memory function in schizophrenia. Neuropsychopharmacol 2002, 26:75-85.
35. Sacco KA, Termine A, Seyal A, Dudas MM, Vessicchio JC, Krishnan-Sarin S, Jatlow PI, Wexler BE, George TP. Effects of cigarette smoking on spatial working memory and attentional deficits in schizophrenia: involvement of nicotinic receptor mechanisms. Arch Gen Psychiatry 2005, 62:649-659. 10.1001/archpsyc.62.6.649, 15939842.
36. Nuechterlein KH, Green MF, Kern RS, Baade LE, Barch DM, Cohen JD, Essock S, Fenton WS, Frese FJ, Gold JM, Goldberg T, Heaton RK, Keefe RS, Kraemer H, Mesholam-Gately R, Seidman LJ, Stover E, Weinberger DR, Young AS, Zalcman S, Marder SR. The MATRICS Consensus Cognitive Battery, part 1: test selection, reliability, and validity. Am J Psychiatry 2008, 165:203-213. 10.1176/appi.ajp.2007.07010042, 18172019.
37. Kern RS, Nuechterlein KH, Green MF, Baade LE, Fenton WS, Gold JM, Keefe RS, Mesholam-Gately R, Mintz J, Seidman LJ, Stover E, Marder SR. The MATRICS Consensus Cognitive Battery, part 2: co-norming and standardization. Am J Psychiatry 2008, 165:214-220. 10.1176/appi.ajp.2007.07010043, 18172018.
38. Breier A, Schreiber JL, Dyer J, Pickar D. National Institute of Mental Health longitudinal study of chronic schizophrenia. Prognosis and predictors of outcome. Arch Gen Psychiatry 1991, 48:239-246.
39. Ho BC, Nopoulos P, Flaum M, Arndt S, Andreasen NC. Two-year outcome in first-episode schizophrenia: predictive value of symptoms for quality of life. Am J Psychiatry 1998, 155:1196-1201.
40. Wildeboer KM, Zheng L, Choo KS, Stevens KE. Ondansetron results in improved auditory gating in DBA/2 mice through a cholinergic mechanism. Brain Res 2009, 1300:41-50. 10.1016/j.brainres.2009.08.075, 19728991.
41. Adler LE, Cawthra EM, Donovan KA, Harris JG, Nagamoto HT, Olincy A, Waldo MC. Improved P50 auditory gating with ondansetron in medicated schizophrenia patients. Am J Psychiatry 2005, 162:386-388. 10.1176/appi.ajp.162.2.386, 15677607.
42. Levkovitz Y, Arnest G, Mendlovic S, Treves I, Fennig S. The effect of ondansetron on memory in schizophrenic patients. Brain Res Bull 2005, 65:291-295. 10.1016/j.brainresbull.2003.09.022, 15811593.
43. Zhang ZJ, Kang WH, Li Q, Wang XY, Yao SM, Ma AQ. Beneficial effects of ondansetron as an adjunct to haloperidol for chronic, treatment-resistant schizophrenia: a double-blind, randomized, placebo-controlled study. Schizophr Res 2006, 88:102-110. 10.1016/j.schres.2006.07.010, 16959472.
44. Akhondzadeh S, Mohammadi N, Noroozian M, Karamghadiri N, Ghoreishi A, Jamshidi AH, Forghani S. Added ondansetron for stable schizophrenia: a double blind, placebo controlled trial. Schizophr Res 2009, 107:206-212. 10.1016/j.schres.2008.08.004, 18789844.
45. Hashimoto K. Nausea associated with a nicotinic agonist therapy in schizophrenia. Clin Psychopharmacol Neurosci 2009, 7:26-27.
46. Waldo MC, Woodward L, Adler LE. Varenicline and P50 auditory gating in medicated schizophrenic patients: A pilot study. Psychiatry Res 2010, 175:179-180. 10.1016/j.psychres.2009.01.025, 19959243.
47. Freedman R. Exacerbation of schizophrenia by varenicline. Am J Psychiatry 2007, 164:1269. 10.1176/appi.ajp.2007.07020326, 17671295.
48. Moore TJ, Cohen MR, Furberg CD. Strong safety signal seen for new varenicline risks. Institute of Safe Medication Practices , http://www.ismp.org/docs/vareniclinestudy.asp
49. Freedman R, Hall M, Adler LE, Leonard S. Evidence in postmortem brain tissue for decreased numbers of hippocampal nicotinic receptors in schizophrenia. Biol Psychiatry 1995, 38:22-33. 10.1016/0006-3223(94)00252-X, 7548469.
50. Court J, Spurden D, Lloyd S, McKeith I, Ballard C, Cairns N, Kerwin R, Perry R, Perry E. Neuronal nicotinic receptors in dementia with Lewy bodies and schizophrenia: α-bungarotoxin and nicotine binding in the thalamus. J Neurochem 1999, 73:1590-1597. 10.1046/j.1471-4159.1999.0731590.x, 10501205.
51. Guan ZZ, Zhang X, Blennow K, Nordberg A. Decreased protein level of nicotinic receptor α7 subunit in the frontal cortex from schizophrenic brain. NeuroReport 1999, 10:1779-1782. 10.1097/00001756-199906030-00028, 10501574.
52. Hashimoto K, Nishiyama S, Ohba H, Matsuo M, Kobashi T, Takahagi M, Iyo M, Kitashoji T, Tsukada H. [11C]CHIBA-1001 as a novel PET ligand for α7 nicotinic receptors in the brain: a PET study in conscious monkeys. PLoS ONE 2008, 3:e3231. 10.1371/journal.pone.0003231, 2529405, 18800169.
53. Toyohara J, Sakata M, Wu J, Ishikawa M, Oda K, Ishii K, Iyo M, Hashimoto K, Ishiwata K. Preclinical and the first clinical studies on [11C]CHIBA-1001 for mapping α7 nicotinic receptors by positron emission tomography. Ann Nucl Med 2009, 23:301-309. 10.1007/s12149-009-0240-x, 19337782.
54. Keefe RS, Goldberg TE, Harvey PD, Gold JM, Poe MP, Coughenour L. The Brief Assessment of Cognition in Schizophrenia: reliability, sensitivity, and comparison with a standard neurocognitive battery. Schizophrenia Res 2004, 68:283-297.
55. Pietrzak RH, Olver J, Norman T, Piskulic D, Maruff P, Snyder PJ. A comparison of the CogState Schizophrenia Battery and the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Battery in assessing cognitive impairment in chronic schizophrenia. J Clin Exp Neuropsychol 2010, 31:848-859.