Challenges in the development of clinical trials for major depressive disorder: lessons learned from trials in minor depression.
This paper reviews some of the challenges faced by individuals who design and implement clinical trials of potential antidepressant medications. Particular emphasis is placed on questioning the validity of some of the theoretical assumptions that form the underpinnings of most conventional trials. Work from our group developing clinical trial methodology for minor depression is used as an example of how alternate constructs may be helpful to differentiate drug-placebo differences.
Department of Psychiatry, Cedars-Sinai Medical Center, Los Angeles, Calif, USA; Department of Psychiatry, University of California, Los Angeles, Los Angeles, Calif, USA.
Mark H
MH
Rapaport
Rachel E
RE
Maddux