Evidence-Based Reviews

From a trickle to a flood: Pipelines fill with psychotropics for children

Current Psychiatry. 2002 October;1(10):67-71

References

1. Olfson M, Marcus SC, Weissman MM, Jensen PS. National trends in the use of psychotropic medications by children. J Am Acad Child Adolesc Psychiatry 2002;41(5):514-21.

2. Rushton JL, Whitmire JT. Pediatric stimulant and selective serotonin reuptake inhibitor prescription trends 1992 to 1998. Arch Pediatr Adolesc Med 2001;155:560-5.

3. Zito JM, Safer DJ, dosReis S, Gardner JF, Boles M, Lynch F. Trends in the prescribing of psychotropic medications to preschoolers. JAMA 2000;283:1025-30.

4. DeVeaugh-Geiss J. OCD: A model for closing the “gap” between adult and pediatric psychiatry. In: Maj M, Sartorius N, Okasha A, Zohar J (eds). World Psychiatric Association series, Evidence and experience in psychiatry (vol. 4). Obsessive-compulsive disorder. Chichester, UK: John Wiley & Sons, 2000:192-4.

5. DeVeaugh-Geiss J, Moroz G, Biederman J, et al. Clomipramine hydrochloride in childhood and adolescent obsessive compulsive disorder: a multicenter trial. J Am Acad Child Adolesc Psychiatry 1992;31(1):45-9.

6. Clomipramine Collaborative Study Group. Clomipramine in the treatment of obsessive compulsive disorder. Arch Gen Psychiatry 1991;48:730-8.

7. Vitiello B, Jensen P. Medication development and testing in children and adolescents: current problems, future directions. Arch Gen Psychiatry 1997;54:871-6.

8. Walkup J, Labellarte M, Riddle M, et al. Fluvoxamine for the treatment of anxiety disorders in children and adolescents. N Engl J Med 2001;344:1279-85.

9. RUPP Autism Network. A double-blind, placebo-controlled trial of risperidone in children with autism. N Engl J Med 2002;347:314-321.

10. Pharmaceutical Research and Manufacturers of America list of new medicines in development. Available at: http://www.phrma.org/searchcures/newmeds/. Accessed Aug. 26 2002.

11. R&D Directions, e-Knowledge Base online databases 2002 (a subscription database). Available at: www.pharmalive.com.

12. National Institute of Mental Health clinical trials. Available at: http://www.nimh.nih.gov/studies/index.cfm. Accessed July 2002.

13. American Academy of Child and Adolescent Psychiatry clinical trials and surveys. Available at: http://www.aacap.org/research/ctvn.htm. Accessed July 2002.

The pharmaceutical companies’ decisions to conduct clinical trials in children and adolescents for this group of drugs may be attributable, to some extent, to incentives and the potential for financial gain. Whatever the reasons, the regulatory changes that stimulated this work will have accomplished their goal if they produce evidence of efficacy, safety, and tolerability of these marketed drugs in children and adolescents.

Noncommercial reserach. In addition to industry-sponsored drug development, much pediatric psychopharmacology research is also being conducted in academic and government settings. NIMH and the AACAP are sponsoring trials for a range of pediatric disorders, including ADHD, autism and other pervasive development disorders, bipolar disorder, body dysmorphic disorder, depression, OCD, PTSD, schizophrenia, social phobia, and Sydenham chorea.^12,13

Unmet needs

The breadth of indications being investigated in pediatric psychopharmacology clinical trials shows that progress is being made. Missing are NCEs being developed for indications other than ADHD, but the FDA’s Final Pediatric Rule does create the expectation that pediatric studies will be included in all future new drug development programs.

Related resources

Food and Drug Administration pediatric Web site. http://www.fda.gov/cder/pediatric
American Academy of Child and Adolescent Psychiatry. Pediatric Psychopharmacology Initiative. http://www.aacap.org/research/ppi.htm

Drug brand names

Busipirone • BuSpar
Clomipramine • Anafranil
Donepezil • Aricept
Fluoxetine • Prozac
Fluvoxamine • Luvox
Imipramine • Tofranil
Mecamylamine • Inversine
Methylphenidate • MethylPatch, Ritalin QD
Mirtazapine • Remeron
Modafinil • Provigil
Nefazodone • Serzone
R-methylphenidate • Attenade
Risperidone • Risperdal
Secretin • SecreFlo
Sertraline • Zoloft
Topiramate • Topamax
Venlafaxine • Effexor XR

Disclosure

The author reports that he receives grant/research support from Synaptic Pharmaceutical Corp., is a consultant to GlaxoSmithKline, Elan Corp., and Cytospect, and owns stock in GlaxoSmithKline. No GlaxoSmithKline products are mentioned in this article.

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From a trickle to a flood: Pipelines fill with psychotropics for children

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From a trickle to a flood: Pipelines fill with psychotropics for children

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