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  • Print publication year: 2012
  • Online publication date: July 2012

Chapter 10 - Medical writing for CNS indications


This chapter discusses how new psychotropic drugs are approved for clinical use. While the FDA regulates other therapeutics such as biologics, over-the-counter drugs, and medical devices, the chapter provides an overview of the FDA's regulation of prescription drug products. The FDA's authorities are largely devoted to pre-marketing and post-marketing risk-benefit evaluation. An investigational new drug (IND) is used in a clinical investigation. The IND is unique to the regulatory process for drug approval. Center for Drug Evaluation and Research (CDER) classifies New Drug Applications (NDAs) with a code that reflects both the type of drug being submitted as well as the intended use. To monitor the safety of marketed drugs, the FDA maintains a complex system of postmarketing surveillance and risk-assessment systems to investigate the occurrence of serious and unexpected adverse drug experiences. The FDA's Adverse Event Reporting System (AERS) is an important drug safety tool.


American Psychiatric Association. (2000). Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision. Washington DC, APA.
American Psychiatric Association website: (Accessed 03 January 2010).
Barnes, T. R. (1989). A rating scale for drug-induced akathisia. Brit J Pharmacol, 154, 672–6.
Chouinard, G., Ross-Chouinard, A., Annable, L., et al. (1980). Extrapyramidal Symptom Rating Scale. Can J Neurol Sci, 7, 233.
Clayton, A. H., McGarvey, E. L., and Clavet, G. J. (1997). The Changes in Sexual Functioning Questionnaire (CSFQ): development, reliability, and validity. Psychopharmacol Bull, 33 (4), 731–45.
Conners, C. K. (1997). Manual for the Conners' Rating Scales – Revised. North Tonawanda, NY: Multi-Health Systems.
Conners, C. K., Sitarenios, G., Parker, J. D., et al. (1998a). The revised Conners' Parent Rating Scale (CPRS-R): factor structure, reliability and criterion validity. J Abnorm Child Psych, 26 (4), 257–68.
Conners, C. K., Sitarenios, G., Parker, J. D., et al. (1998b). Revision and restandardization of the Conners Teacher Rating Scale (CTRS-R): factor structure, reliability, and criterion validity. J Abnorm Child Psych, 26 (4), 279–91.
Cornier, M.-A., Dabelea, D., Hernandez, T. L., et al. (2008). The metabolic syndrome. Endocr Rev, 29 (7), 777–822.
Corona, G., Ricca, V., Bandini, E., et al. (2009). Selective serotonin reuptake inhibitor-induced sexual dysfunction. J Sex Med, 6, 1259–69.
Delay, J., Pichot, P., Lemperiere, T., et al. (1960). A non-phenothiazine and non-reserpine major neuroleptic, haloperidol, in the treatment of psychoses. Ann Med Psychol (Paris), 118 (1), 145–52.
DuPaul, G. J., Power, T. J., Anastopoulos, A. D., et al. (1998). ADHD Rating Scale-IV: Checklists, normals, and clinical interpretation. New York: Guilford Press.
Endicott, J., Nee, J., Harrison, W., and Blumenthal, R. (1993). Quality of Life Enjoyment and Satisfaction Questionnaire: a new measure. Psychopharmacol Bull, 29, 321–6.
Ewing, J. A. (1984). Detecting alcoholism: the CAGE Questionnaire. J Am Med Assoc, 252 (14), 1905–7.
First, M. B., Spitzer, R. L., Gibbon, M., et al. (1995). Structured Clinical Interview for DSM-IV Axis I Disorders. New York, NY: State Psychiatric Institute, Biometrics Research.
Goldenberg, I., Moss, A. J., and Zareba, W. (2006). QT interval: how to measure it and what is “normal”. J Cardiovasc Electrophysiol, 17, 333–6.
Goodman, W. K., Price, L. H., Rasmussen, S. A., et al. (1989a). The Yale-Brown Obsessive Compulsive Scale I: development, use, and reliability. Arch Gen Psychiat, 46 (11), 1006–11.
Goodman, W. K., Price, L. H., Rasmussen, S. A., et al. (1989b). The Yale-Brown Obsessive Compulsive Scale II: validity. Arch Gen Psychiat, 46 (11), 1012–16.
Guy, W. (1976). ECDEU Assessment Manual for Psychopharmacology, Revised 1976. Rockville (MD): (NIMH) National Institute of Mental Health, Psychopharmacology Research Branch.
Hamilton, M. (1959). The assessment of anxiety states by rating. Br J Med Psychol, 32, 50–5.
Hamilton, M. (1960). A rating scale for depression. J Neurol Neurosurg Psy, 23, 56–62.
Heinrichs, D. W., Hanlon, T. E., and Carpenter, W. T. (1984). Quality of Life scale: an instrument for rating the schizophrenic deficit scale. Schizophrenia Bull, 10, 388–98.
ICH E3 Guideline for Industry: Structure and Content of Clinical Study Reports, July 1996.
Kaufman, J., Birmaher, B., Brent, D. A., et al. (2000). K-SADS-PL. J Am Acad Child Adolesc Psychiatr, 39 (1), 49–58.
Kay, S. R., Fiszbein, A., and Opler, L. A. (1987). The Positive and Negative Syndrome Scale (PANSS) for schizophrenia. Schizophrenia Bull, 13, 261–76.
Kay, S. R., Opler, L. A., and Lindenmayer, J. P. (1988). Reliability and validity of the Positive and Negative Syndrome Scale for schizophrenics. Psychiat Res, 23, 99–110.
Kennedy, S. H. and Rizvi, S. (2009). Sexual dysfunction, depression, and the impact of antidepressants. J Clinic Psychopharmacol, 29 (2), 157–64.
Lieb, J. and Balter, A. (1984). Antidepressant tachyphylaxis. Med Hypotheses, 15 (3), 279–91.
Liebowitz, M. R. (1987). Social phobia. Mod Probl Pharmacopsychiat, 22, 141–73.
Lindenmayer, J. P., Czobor, P., Alphs, L., et al. (2003). The InterSePT scale for suicidal thinking reliability and validity. Schizophrenia Res, 63, 161–70.
Lingjaerde, O., Ahlfors, U. G., Bech, P., et al. (1987). The UKU Side Effect Rating Scale. A new comprehensive rating scale for psychotropic drugs and a cross-sectional study of side effects in neuroleptic-treated patients. Acta Psychiatr Scand Suppl, 334, 1–100.
McEvoy, J., Meyer, J., Goff, D., et al. (2005). 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. Schizophrenia Res, 66 (1), 19–32.
McGahuey, C. A., Gelenberg, A. J., Laukes, C. A., et al. (2000). The Arizona Sexual Experiences Scale (ASEX): reliability and validity. J Sex Marital Ther, 26 (1), 25–40.
Monteleone, P., Martiadis, V., and Maj, M. (2009). Management of schizophrenia with obesity, metabolic, and endocrinological disorders. Psychiat Clin N Am, 32 (4), 775–94.
Montgomery, S. A. and Asberg, M. (1979). A new depression scale designed to be sensitive to change. Brit J Psychiat, 134, 382–9.
Overall, J. E. and Gorham, D. R. (1962). The Brief Psychiatric Rating Scale. Psychol Rep, 10, 799–812.
Overall, J. E. and Gorham, D. R. (1988). The Brief Psychiatric Rating Scale: recent developments in ascertainment and scaling. Psychopharmacol Bull, 24, 97–9.
Posner, K., Melvin, G. A., Stanley, B., et al. (2007). Factors in the assessment of suicidality in youth. CNS Spectr, 12, 156–62.
Rush, A. J., Giles, D. E., Schlesser, M. A., et al. (1986). The Inventory of Depressive Symptomatology (IDS): preliminary findings. Psychiat Res, 18, 65–87.
Rush, A. J., Gullion, C. M., Basco, M. R., et al. (1996). The Inventory of Depressive Symptomatology (IDS): psychometric properties. Psychol Med, 26, 477–86.
Rush, A. J., Trivedi, M. H., Ibrahim, H. M., et al. (2003). The 16-Item Quick Inventory of Depressive Symptomatology (QIDS), clinician rating (QIDS-C), and self report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiat, 54 (5), 573–83.
Sachs, G. S. (2004). Strategies for improving treatment of bipolar disorder: integration of measurement and management. Acta Psychiatr Scand Suppl, 422, 7–17.
Sajatovic, M. and Ramirez, L. F. (2001). Rating Scales in Mental Health. Hudson, OH: Lexi-Comp Inc.
Schechter, D., Endicott, J., and Nee, J. (2007). Quality of life of ‘normal’ controls: association with lifetime history of mental illness. Psychiat Res, 152, 45–54.
Schweitzer, I., Maguire, K., and Ng, C. (2009). Sexual side-effects of contemporary antidepressants: review. Aust NZ J Psychiat, 43, 795–808.
Sheenhan, D. V. (1983). The Anxiety Disease. New York: Scribner's.
Sheehan, D. V., Lecrubier, Y., Harnett, Sheehan K., et al. (1998). The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. Journal of Clinical Psychiatry, 59 (Suppl 20), 22–57.
Sheehan, D. V., Harnett-Sheehan, K., and Raj, B. A. (1996). The measurement of disability. Int Clin Psychopharmacol, 11 (suppl 3), 89–95.
Simpson, G. N. and Angus, J. W. S. (1970). A rating scale for extrapyramidal side effects. Acta Psychiatr Scand Suppl, 212, 11–19.
Straker, D., Correll, C. U., Kramer-Ginsberg, E., et al. (2005). Cost effective screening for the metabolic syndrome in patients treated with second-generation antipsychotic medications. Am J Psychiat, 162, 1217–21.
Strawn, J. R., Keck, P. E. Jr, and Caroff, S. N. (2007). Neuroleptic malignant syndrome. Am J Psychiat, 164 (6), 870–6.
Trollor, J. N., Chen, X., and Sachdev, P. S. (2009). Neuroleptic malignant syndrome associated with atypical antipsychotic drugs. CNS Drugs, 23 (6), 477–92.
Tschoner, A., Engl, J., Laimer, M., et al. (2007). Metabolic side effects of antipsychotic medication. Int J Clin Pract, 61 (8), 1356–70.
Tschoner, A., Fleischhacker, W. W., and Ebenbichler, C. F. (2009). Experimental antipsychotics and metabolic adverse effects – findings from clinical trials. Curr Opin Investigational Drugs, 10 (10), 1041–8.
Vieweg, W. V., Wood, M. A., Fernandez, A., et al. (2009). Proarrythmic risk with antipsychotic and antidepressant drugs: implications in the elderly. Drugs Aging, 26 (12), 997–1012.
Voruganti, L. N. P. and Awad, A. G. (2002). Personal Evaluation of Transitions in Treatment (PETiT): a scale to measure subjective aspects of antipsychotic drug therapy in schizophrenia. Schizophrenia Res, 56, 37–46.
Walsh, B. T., Seidman, S. N., Sysko, R., and Gould, M. (2002). Placebo response in studies of major depression: variable, substantial, and growing. J Am Med Assoc, 287 (14), 1840–7.
Weiden, P. J., Mackell, J. A., and McDonnell, D. D. (2004). Obesity as a risk factor for antipsychotic noncompliance. Schizophrenia Res, 66, 51–7.
Young, R. C., Biggs, J. T., Siegler, V. E., et al. (1978). A rating scale for mania: reliability, validity, and sensitivity. Brit J Psychiat, 133, 429–35.