The history and current state of antidepressant clinical trial design: A call to action for proof-of-concept studies Conference Paper uri icon

Overview

MeSH Major

  • Antidepressive Agents
  • Clinical Trials as Topic
  • Depressive Disorder, Major
  • Research Design

abstract

  • The participants concluded that the federal government, academic centers, and the pharmaceutical industry need to collaborate on establishing a network of sites at which small, POC studies can be conducted and resulting data can be shared. New technologies to analyze and measure the major affective, cognitive, and behavioral components of depression in relationship to potential biomarkers of response should be incorporated. Standard assessment instruments should be employed across studies to allow for future meta-analyses, but new instruments should be developed to differentiate subtypes and symptom clusters within the disorder that might respond differently to treatment. Better early-stage POC studies are needed and should be able to amplify the signal strength of drug efficacy and enhance the quality of information in clinical trials of new medications with novel pharmacologic profiles.

publication date

  • October 2008

Research

keywords

  • Conference Paper

Identity

Language

  • eng

PubMed ID

  • 19192434

Additional Document Info

start page

  • 1513

end page

  • 28

volume

  • 69

number

  • 10