Donald S. Robinson, M.D.
REFERENCES
1. Altman DG, Dore CJ. Randomization and baseline comparisons in clinical trials. Lancet 1990;335:149-153.
2. American College of Physicians. Cognitively impaired subjects. Ann Int Med 1989;3:843-848.
3. Anton SF, Robinson DS, Roberts DL et al. Long-term treatment with nefazodone. Psychopharmacol Bull 1994;30:165-169.
4. Andreassen NC, Flaum M, Arndt S. The Comprehensive Assessment of Symptoms and History (CASH): an instrument for assessing diagnosis and psychopathology. Arch Gen Psychiatry 1992;49:615-623.
5. Andreassen NC, Arndt S, Alliger R, Miller D, Flaum M. Symptoms of schizophrenia: methods, meanings and mechanisms. Arch Gen Psychiatry 1995;52:341-351.
6. Banta HD. Quality of life. Perspectives. Pharm World Sci 1993;15:45-49.
7. Bielski RJ, Lydiard RB. Cost factors in subject recruitment. Psychopharmacol Bull 1996;32:414.
8. Brown CH. Principles for designing preventive trials in mental health. Personal communication 1996.
9. Castle WM. Problems in assessing drug safety: A plea for improved methodology and a possible route. Drug Info J 1986;20:323-326.
10. Chalmers I. Underreporting research is scientific misconduct. JAMA 1990;263:1405-1408.
11. Chalmers I, Adams M, Dickersin K et al. A cohort study of summary reports of controlled trials. JAMA 1990;263:1401-1405.
12. Code of Federal Regulations-Public Health(1989). Confidentiality of alcohol and drug abuse patient records, vol.42 CFR2,2a. Octobeer1,1989.
13. Curran WJ. Ethical and legal considerations in high risk studies of schizophrenia. Schizophrenia Bull 1974;10:74-92.
14. D'Amico F, Roberts DL, Robinson DS et al. Placebo-controlled dose-ranging trial designs in phase II development of nefazodone. Psychopharmacol Bull 1990;26:147-150.
15. Drummond M, Stoddart G, Labelle R, Cushman R. Health economics: An introduction for clinicians. Ann Int Med 1987;107:89-92.
16. Drummond MF, Stoddart GL, Torrance GW. Methods for the Economic Evaluation of Health Care Programmes. Oxford: Oxford University Press, 1987.
17. Ekstrom D, Quade D, Golden RN. Statistical analysis of repeated measures in psychiatric research. Arch Gen Psychiatry 1990;47:770-772.
18. Eddy DM. Cost-effectiveness analysis. JAMA 1992;267:1669-1675.
19. Fisher S, Bryant SG, Kent J. Post-marketing surveillance by patient self-monitoring: Trazodone versus fluoxetine. J Clin Psychopharmacology 1993;13;235-242.
20. Fisher S, Greenberg RP. How sound is the double-blind design for evaluating psychotropic drugs? J Nerv Ment Dis.1993;186:345-350.
21. Fletcher J, Wichman A. A new consent policy for research with impaired human subjects. Psychopharmacol Bull 1987;23:382-385.
22. Food and Drug Administration. General Considerations for the Clinical Evaluation of Drugs HEW Publ No. 77-3040. Washington, DC: Government Printing Office; 1977.
23. Food and Drug Administration. Guidelines for the clinical evaluation of psychotropic drugs—antidepressant and antianxiety drugs. Psychopharmacol Bull 1978;14:45-63.
24. Kelsey FO. Good clinical practices in the US: impact of European guidelines. Drug Info J1992; 26:125-132.
25. Gardner MJ, Bond J. An exploratory study of statistical assessment of papers published in the British Medical Journal. JAMA 1990;263:1355-1357.
26. Glynn JR. A question of attribution. Lancet 1993;342:530-532.
27. Goldberg SC, Schooler NR, Davidson EM, Kayce M. Sex and race differences in response to drug treatment among schizophrenics. Psychopharmacologia 1966;31:31-47.
28. Greenhouse JP, Stangl D, Kupfer DJ, Prien RF. Methodologic issues in maintenance therapy in clinical trials. Arch Gen Psychiatry 1991;48:313-318.
29. Guy W, Cleary P, Bonato RR. Methodological implications of a large central data system. Proceedings IXth Congress CINP. Amsterdam: Excerpta Medica, 1975.
30. Guyatt GH, Heyting A, Jaeschke R et al. N of 1 randomized trials for investigating new drugs. Controlled Clin Trials 1990;11;88-100.
31. Hamilton M. Development of a rating scale for primary depressive illness. Br J Soc Clin Psych 1967;6:278-296.
32. Hamilton M. Diagnosis and rating of anxiety. Br J Psychiatry 1969;3:76-79.
33. Harvey PD, Davidson M, White L, et al. Empirical evaluation of the factorial structure of clinical symptoms in schizophrenia: effects of typical neuroleptics on the Brief Psychiatric Rating Scale. Biological Psychiatry 1996;40:755-760.
34. Hellman S, Hellman DS. Of mice but not men. New Eng J Med 1991;324:1585-1589.
35. Hollister LE, Jones JK, Fisher S. Post-Marketing Surveillance of Drugs. In: Prien RF, Robinson DS, eds. Clinical Evaluation of Psychotropic Drugs: Principles and Guidelines. New York: Raven Press, 1994;217-236.
36. Hulley SB, Cummings SR. Planning the measurements: precision and accuracy. In: Hulley SB, Cummings SR, eds. Designing Clinical Research: An Epidemiologic Approach. Baltimore: Williams & Wilkins, 1988;31-41.
37. Huston P, Moher P. Redundancy, disaggregation, and the integrity of medical research. The Lancet 1996;347:1024-1026.
38. Kane J, Honingfeld G, Singer J, et al. Clozapine for the treatment-resistant schizophrenic. Arch Gen Psychiatry 1988;45:789-796.
39. Kane JM, Schooler NR, Marder SR, Simpson GM, Casey DE. Methods for the clinical evaluation of pharmacologic treatments of schizophrenia. In: Prien RF, Robinson DS, eds. Clinical Evaluation of Psychotropic Drugs: Principles and Guidelines, New York: Raven Press, 1994.
40. Kane JM, Borenstein R. The use of placebo controls in psychiatric research. Presented at: "Conference on Ethics in Neurobiologic Research with Human Subjects" Baltimore MD, January 7-9, 1995.
41. Kartzinel R, Lisook AB, Rulls B et al. Clinical trial implementation. In: Prien RF, Robinson DS, eds. Clinical Evaluation of Psychotropic Drugs: Principles and Guidelines. New York: Raven Press, 1994;161-184.
42. Kay SR. Positive and Negative Symptoms of Schizophrenia New York: Brunner/Malleal, 1991.
43. Kelsey FO. Good clinical practices in the US: Impact of European guidelines. Drug Info J 1992;26:125-132.
44. Kraemer HC. To increase power in randomized clinical trials without increasing sample size. Psychopharmacol Bull 1991;27:217-224.
45. Kraemer HC, Telch CF. Selection and utilization of outcome measures in psychiatric clinical trials. Neuropsychopharmacology 1992;7:85-94.
46. Kupfer DJ, Kraemer HC, Bartko JJ. Documenting and reporting study results of a randomized clinical trial. In: Prien RF, Robinson DS, eds. Clinical Evaluation of Psychotropic Drugs: Principles and Guidelines. New York: Raven Press, 1994;237-260.
47. Kupfer DJ, Rush AJ. Recommendations for depression publications. Arch Gen Psychiatry 1983;40.
48. Larson EB, Ellsworth AJ, Oas J. Randomized clinical trials in single patients during a 2-year period. JAMA 1993;270:2708-2712.
49. Laska EM. Epilogue, prologue, and a bayesian approach. In: Levine J, ed. Coordinating Clinical Trials in Psychopharmacology: Planning, Documentation, and Analysis. Washington, DC: U.S. Government Printing Office, 1979.
50. Laska EM, Klein DF, Lavori PW et al. Design issues for the clinical evaluation of psychotropic drugs. In: Prien RF, Robinson DS, eds. Clinical Evaluation of Psychotropic Drugs: Principles and Guidelines. New York: Raven Press, 1994;29-67.
51. Laughren TP, Levine J, Levine J, Thompson WL. Premarketing safety evaluation of psychotropic drugs. In: Prien RF, Robinson DS, eds. Clinical Evaluation of Psychotropic Agents: Principles and Guidelines. New York: Raven Press, 1994;185-216
52. Lavori P. Statistical issues: Sample size and dropout. In: Benkert O, Maier W, Rickels K, eds. Methodology of the Evaluation of Psychotropic Drugs. Berlin: Springer-Verlag, 1990;91-104.
53. Lavori P. ANOVA, MANOVA, my black hen. Comments on repeated measures. Arch Gen Psychiatry 1990;47:775-778.
54. Lavori P. Clinical trials in psychiatry: Should protocol deviation censor patient data? Neuropsychopharmacology 1992;6:39-48.
55. Leber P. Is there an alternative to the randomized controlled trial? Psychopharmacol Bull 1991;27:3-8.
56. Leff JP, Wing JK. Trial of maintenance therapy in schizophrenia. Br J Psychiatry 1971;3:559-604.
57. Lerfald SC. Advertisement as a recruitment approach in psychopharmacological research: A comparison with office-based patients. Psychopharmacol Bull 1996;332:475.
58. Levine J, Schooler N. Strategies for analysing side effects data from SAFTEE. Psychopharmacol Bull 1986;22:343-381.
59. Levy G. Concentration-controlled versus concentration-defined clinical trials. Clin Pharm Ther 1993;53:385-388.
60. Liddle PF. The symptoms of chronic schizophrenia: a re-examination of the positive-negative dichotomy. Br J Psychiatry 1987; 151:145-151.
61. Lindenmayer JP, Bernstein-Hyman RB, Groshofsky F. Five factor model of schizophrenia: a replication. J Nerv Ment Disease 1994;182:631-638.
62. Marder SR, Meibach RC. Risperidone in the treatment of schizophrenia. Am J Psychiatry 1994;151:825-835.
63. McCormack RA. Experimental subjects. JAMA 1976;235:2197.
64. Miller C, Hooper CL, Bakish D. A comparison of patients with major depressive disorder recruited through newspaper advertising versus consultation referrals for clinical trials. Psychopharmacol Bull 1996;32:488.
65. Mosteller F, Gilbert JP, McPeek B. Reporting standards and research strategies for controlled trials. Controlled Clin Trials 1980;1:37-58.
66. Mueser KT, Curran PJ, McHugo GJ. The factor structure of the Brief Psychiatric Rating Scale in schizophrenia. Psychological Assessment 1997, in press.
67. Overall JE, Gorham DR. The Brief Psychiatric Rating Scale. Psychol Rep 1962;10:799-812.
68. Overall JE. The Brief Psychiatric Rating Scale in psychopharmacologic research. Mod Probl Pharmacopsychiatry 1974;7:67-78.
69. Overall JE, Ashby B. Baseline corrections in experimental and quasi-experimental clinical trials. Neuropsychopharmacology 1981;4:273-281.
70. Passamani E. Clinical trials—Are they ethical? New Eng J Med 1991;22:1589-1591.
71. Peck CC. The randomized concentration-controlled clinical trial: An information rich alternative to the randomized placebo-controlled trial. Clin Pharm Ther 1990;47:126.
72. Physicians' Desk Reference Montvale NJ: Medical Economics Co. 1996.
73. Preskorn SH, Mac DS. The implication of concentration/response studies of tricyclic antidepressants for psychiatric research and practice. Psychiatr Dev 1984;11:210-222.
74. Prien RF. Methods and models for placebo use in pharmacotherapeutic trials. Psychopharmacol Bull 1988;24:4-8.
75. Prien RF, Robinson DS, eds. Clinical Evaluation of Psychotropic Drugs: Principles and Guidelines. New York, Raven Press, 1994.
76. Quitkin FM, Kane J, Rifkin A, et al. Prophylactic lithium with and without imipramine for bipolar I patients. Arch Gen Psychiatry 1981;38:902-907.
77. Rabkin JG, Markowitz JS, Ocepek-Welikson K, Wager SS. General versus systematic inquiry about emergent clinical events with SAFTEE: Implications for clinical research.J Clin Psychiatry 1992;12:3-10.
78. Ray CC, Griffin MR, Avorn J. Evaluating drugs after their approval for clinical use. New Eng J Med 1993;329:2029-2032.
79. Robinson D, Woerner MG, Pollack S, Lerner G. Subject selection biases in clinical trials: Data from a multicenter schizophrenia treatment study. J Clin Psychopharmacology 1996;16:170-176.
80. Rodwin MA. Legally required disclosure of conflicts of interests. New Eng J Med 1990;323:1711.
81. Roth LH, Appelbaum PS, Lidz C et al. Informed consent in psychiatric research. Rutgers Law Research 1987;39:425-441.
82. Rothman KJ. Significance questing. Ann Int Med 1986;105:445-447.
83. Rush AJ, Raskin A, Kellner R, Bartko JJ. Assessment and measurement of clinical change. In: Prien RF, Robinson DS, eds. Clinical Evaluation of Psychotropic Drugs: Principles and Guidelines. New York: Raven Press, 1994;85-122.
84. Sanathanan LP, Peck CC. The randomized concentration-controlled trial: An evaluation of its sample size efficiency. Controlled Clin Trials 1991;12:780-794.
85. Schooler NR. Maintenance medication for schizophrenia: Strategies for dose reduction. Schizophrenia Bull 1991;17:311-323.
86. Schooler NR, Keith SJ, Severe JB, et al. Relapse and rehospitalization during maintenance treatment of schizophrenia: the effects of dose reduction and family treatment. Arch Gen Psychiatry 1997, in press.
87. Simon R. Confidence intervals for reporting results of clinical trials. Ann Int Med 1986;105:420-435.
88. Spilker B, ed. Quality of Life Assessments in Clinical Trials. New York: Raven Press, 1990.
89. Spitzer RL, First MB, Gibbon M, Williams JBW. Structured Clinical Interview for DSM-IV Axis I Disorders—Patient Edition (SCID-I/P, Version 2.0) Biometrics Research Department, New York State Psychiatric Institute, 1995.
90. Tam YK. Individual variation in first-pass metabolism.Clin Pharmacokinetics 1993;4:300-328.
91. US Department of Health, Education and Welfare. Protection of identity—research subjects. Federal Register. 1979 Apr 4;44(66).
92. Wells KB, Steward A, Hayes RD. The functioning and well-being of depressed patients: results from the Medical Outcomes Study. JAMA 1989;262:914-919.
93. Wilson JF, Tsanaclis LM, Williams J et al. External quality assurance of tricyclic antidepressant measurements in serum: Eight years of progress? Therapeutic Drug Monitoring 1989;11:196-199.
published 2000