Schizophrenia trial

A related issue is the question of which patients to include in an evaluation. The most usefirl evaluation would be one that included all patients likely to use a service in the real world. However, in order to make evaluations feasible, and because of the need to achieve the informed consent of patients, many prospective clinical trials exclude certain patient groups. For example, many schizophrenia trials exclude patients with... 

Nasrallah, H. (2007). The roles of efficacy, safety, and tolerability in antipsychotic effectiveness Practical implications of the CATIE schizophrenia trial. Journal of Clinical... 

Weiden, P. (2007a). Discontinuing and switching antipsychotic medications Understanding the CATIE schizophrenia trial. Journal of Clinical Psychiatry, 68 (Suppl. 1), 12—19. 

Buchanan RW, Javitt DC, Marder SR, Schooler NR, Gold JM, et al. 2007. The Cognitive and Negative Symptoms in Schizophrenia Trial (CONSIST) The efficacy of glutamatergic agents for negative symptoms and cognitive impairments. Am J Psychiatry 164 1593-1602. 

Baseline neurocognitive deficits in the CATIE schizophrenia trial. Neuropsychopharmacology 31 2033-2046. 

Tsai HT, Caroff SN, Miller DD, McEvoy J, Lieberman JA, North KE et al (2010) A candidate gene study of tardive dyskinesia in the CATIE schizophrenia trial. Am J Med Genet B Neuropsychiatr Genet 153B 336-340... 

McEvoy JP, Meyer JM, Goff DC, et al. Prevalence of the metabolic syndrome in patients with schizophrenia baseline results from the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia trial and comparison with national estimates from NHANES III. Schizophr Res 2005 80 19-32. 

Meyer JM, Davis VG, Goff DC, et al. Change in metabolic syndrome parameters with antipsychotic treatment in the CATIE Schizophrenia trial prospective data from phase 1, Schizophr Res 2008 [Feb 5, Epub ahead of print],... 

Meyer JM, Davis VG, McEvoy JP, Goff DC, Nasrallah HA, Davis SM, Daumit GL, Hsiao J, Swartz MS, Stroup TS, Lieberman JA. Impact of antipsychotic treatment on nonfasting triglycerides in the CAllE Schizophrenia Trial phase 1. Schizophr Res 2008 103(1-3) 104-9. 

Hanssens L, L ltalien G, Loze JY, Marcus RN, Pans M, Kerselaers W. The effect of antipsychotic medication on sexual function and serum prolactin levels in community-treated schizophrenic patients results from the Schizophrenia Trial of Aripiprazole (STAR) study (NCT00237913). BMC Psychiatry 2008 8 95. 

Fleischhacker WW, Siu CO, Bod i R, Pappadopulos E, Karayal ON, Kahn RS, EUFEST study group. Metabolic risk factors in first-episode schizophrenia baseline prevalence and course analysed from the European First-Episode Schizophrenia Trial. Int J Neuropsychopharmacol 2013 16(5) 987-95. 

On the other hand, 5-HT2C agonists are being investigated in obesity, depression, and schizophrenia, and SCA-136, has entered phase II trials in schizophrenia. 

Evins AE, Mays VK, Rigotti NA, et al A pilot trial of bupropion added to cognitive behavioral therapy for smoking cessation in schizophrenia. Nicotine Tob Res 3 397-M03, 2001... 

The validity of pharmacoeconomic data is invariably diminished by two important factors a failure to account for all direct and indirect cost outcomes, and the difficulty of assigning costs to human experiences. In schizophrenia, validity is further reduced by the near-impossibility of conducting trials over several years, or even decades, so as to approach the reality of what is usually a lifelong illness. Given these observations, it would be imprudent to act on the minutiae of data generated in even the best-conducted trials, but it may well be appropriate to draw broad conclusions. 

Trial validity is also grossly affected by the type of trial carried out. In schizophrenia there are several health-care decision models, retrospective mirror-image analyses (with or... 

Edgell ET, Hamilton SH, Revicki DA, et al (1998). Costs of olanzapine treatment compared with haloperidol for schizophrenia results from a randomized clinical trial. Poster presented at the 21st CINP Congress, Glasgow, July 1998. 

Tollefson GD, Beasley CM, Tran PV (1997). Olanzapine versus haloperidol in the treatment of schizophrenia and schizoaffective and schizophreniform disorders results of an international collaborative trial. Am J Psychiatry 154, 457-65. 

Although atypical antipsychotic agents may cost several times as much as traditional antipsychotics, drug costs in schizophrenia account for only 1-4% of the total treatment cost (Knapp, 1997). The argument then is that a small increase in drug costs— say to 10% of total cost—may result in disproportionate savings in the highly expensive direct hospital costs, if clinical trial... 

Jeste DV, Klausner M, Brecher M, et al (1996). A clinical evaluation of risperidone in the treatment of schizophrenia a ten week open label multicentre trial. Psychopharmacology... 

Wahlbeck K, Cheine M, Essali A, Adams C (1999). Evidence of clozapine s effectiveness in schizophrenia a systematic review and metaanalysis of randomised trials. Am J Psychiatry 156, 990-9. 

Investigation of the differences in crystal packing between (431) and (426) from comparison of their respective X-ray structures, revealed that (431) was more tightly packed than (442), reflected in their respective melting points of 235 and 170 °C. It was postulated that the absence of in vivo activity for (431) may be explained by the resultant reduction in water solubility and dissolution rate compared with (426). The comparatively high calculated polar surface area of (431) (122.5A ) compared with (426) (89.3 A ) was also proposed as a factor influencing the marked difference in bioavailability between the two related compounds. Compound (426) (SLV-319) is currently being developed with Bristol-Myers Squibb for the potential treatment of obesity and other metabolic disorders. Phase I trials for obesity were started in April 2004. Earlier Phase I clinical trials for the treatment of schizophrenia and psychosis, which commenced in April 2002, appear to have been abandoned. 

Rimonabant (382) was also included in a clinical study to assess the safety and efficacy of four novel compounds for the treatment of schizophrenia and psychoaffective disorder [378]. The other compounds included in the trial were a neurokinin NK3 antagonist, a serotonin 2A/2C antagonist and a neurotensin NTSl antagonist. Halopeiidol and placebo groups were used as controls in the study. Sixty-nine patients received (382) (20 mg once per day), which failed to demonstrate efficacy in this trial. The reasons for the lack of efficacy may be due to inadequate dosing or an indication that CBi antagonism is not appropriate in the treatment of this condition. 

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