The effects of Psychotropic drugs On Developing brain (ePOD) study: methods and design

BMC Psychiatry. 2014 Feb 19:14:48. doi: 10.1186/1471-244X-14-48.

Abstract

Background: Animal studies have shown that methylphenidate (MPH) and fluoxetine (FLX) have different effects on dopaminergic and serotonergic system in the developing brain compared to the developed brain. The effects of Psychotropic drugs On the Developing brain (ePOD) study is a combination of different approaches to determine whether there are related findings in humans.

Methods/design: Animal studies were carried out to investigate age-related effects of psychotropic drugs and to validate new neuroimaging techniques. In addition, we set up two double-blind placebo controlled clinical trials with MPH in 50 boys (10-12 years) and 50 young men (23-40 years) suffering from ADHD (ePOD-MPH) and with FLX in 40 girls (12-14 years) and 40 young women (23-40 years) suffering from depression and anxiety disorders (ePOD-SSRI). Trial registration numbers are: Nederlands Trial Register NTR3103 and NTR2111. A cross-sectional cohort study on age-related effects of these psychotropic medications in patients who have been treated previously with MPH or FLX (ePOD-Pharmo) is also ongoing. The effects of psychotropic drugs on the developing brain are studied using neuroimaging techniques together with neuropsychological and psychiatric assessments of cognition, behavior and emotion. All assessments take place before, during (only in case of MPH) and after chronic treatment.

Discussion: The combined results of these approaches will provide new insight into the modulating effect of MPH and FLX on brain development.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Animals
  • Antidepressive Agents / pharmacology
  • Antidepressive Agents / therapeutic use*
  • Anxiety Disorders / drug therapy*
  • Anxiety Disorders / psychology
  • Attention Deficit Disorder with Hyperactivity / drug therapy*
  • Attention Deficit Disorder with Hyperactivity / psychology
  • Brain / drug effects*
  • Central Nervous System Stimulants / pharmacology
  • Central Nervous System Stimulants / therapeutic use*
  • Child
  • Cross-Sectional Studies
  • Depressive Disorder / drug therapy*
  • Depressive Disorder / psychology
  • Double-Blind Method
  • Female
  • Fluoxetine / pharmacology
  • Fluoxetine / therapeutic use*
  • Humans
  • Male
  • Methylphenidate / pharmacology
  • Methylphenidate / therapeutic use*
  • Problem Solving
  • Research Design
  • Young Adult

Substances

  • Antidepressive Agents
  • Central Nervous System Stimulants
  • Fluoxetine
  • Methylphenidate