2004N-0330 - Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Pediatric Advisory Committee
FDA Comment Number : EC11
Submitter : Dr. Carol Tamminga Date & Time: 08/30/2004 02:08:00
Organization : American College of Neuropsychopharmacology
Health Care Association
Category :
Issue Areas/Comments
Depression in youth is a serious disorder. It affects school, family and peer relationships, can lead to drug/alcohol abuse and suicide, and is recurrent, often leading to adult depression. Furthermore, depression itself impacts the developing brain. Allowing depression to go untreated significantly delays improvement, thereby increasing the likelihood of long-term negative outcomes.

What do we know about depression?
Over the past 30 plus years, a substantial amount of research has contributed to our understanding of depression in children and adolescents.

In the 1970s clinicians first recognized depression in children. Previously, most believed that children could not become depressed because it was thought that they did not have a sufficiently mature mind.

By the 1980s, depression in children was recognized, but the focus was on trying to determine how to diagnose it reliably. Children were shown to accurately report depressive symptoms, and developmentally appropriate measures were created. At the same time, some similarities in the biological characteristics of depression were noted between children and adults. Long-term naturalistic follow?up studies and family-based studies also confirmed the presence of relationships between depression in adults and juveniles.

In the 1990s, the focus turned to both psychopharmacological and psychological treatment. Generally, the early small sample studies evaluating tricyclic antidepressants were negative and even larger tricyclic studies failed to demonstrate efficacy in depressed children.

In 1997, Emslie et al. carried out an NIMH-sponsored, randomized controlled trial (RCT). This study demonstrated the effectiveness of fluoxetine in the treatment of depression in a relatively small group (N=96) of children and adolescents. Even though that single site study took 5 years to complete, it was clear that more well controlled studies were needed.

Following discussion with academia, NIMH, FDA, and pharmaceutical companies, the FDMA (FDA Modernization Act) was passed in 1997 to encourage research in pediatric pharmacology, not limited to psychiatry. The FDMA met many serious challenges; and, now data are available for the use of a variety of medications in childhood psychiatric disorders, with over 4,000 children and adolescents having been involved in RCT?s.

What do we now know about efficacy?
Experts generally believe that there are strong similarities between depression manifest in juveniles and adults, with accommodation for developmental differences. Nonetheless, it has been treated by the FDA as a distinct indication for registration. Fortunately, recent trials have provided an explosion of data in this area.