Placebo response in depression. Results from a clinical trial in Cuba

Abstract:

Some aspects related with depression and the use of placebo in clinical trials were reviewed considering the Declaration of Helsinki and the criteria exposed by the regulatory agencies from Europe and United States. The possible reasons that could have influenced the high placebo response observed in a clinical trial coordinated by the National Coordinating Centre for Clinical Trials in Cuba (CENCEC) were also analyzed. Among then: spontaneous remission of symptoms, severity of depression, high expectancy from patients and raters, systematic evaluations, etc. We concluded that the high level of placebo response reduces the power of clinical trials and that it is necessary to find new strategies in order to decrease the sources of variability. Considering that in depression it is common to observe a placebo response higher than the rest of diseases, it could be justifiable to use it in the evaluation of new antidepressants if it does not affect the safety and integrity of the patients.

Año de publicación:

2007

Keywords:

• Depression
• antidepressants
• Clinical trial
• Placebo

Fuente:

scopus