Phase 1 clinical trials in psychopharmacology

Phase 1 trials are an important step in drug development and are usually the first that involve human participants. Their main objective is most often to determine a safe and effective dose range for further clinical development of the drug. Specific guidelines and regulations apply to these type of trials and have been laid down by health authorities. These guidelines are aimed at minimizing the risks and maximizing the benefits and concern the trial's objective, design, methodology, and organization. To obtain approval for a clinical trial, a Clinical Trial Application, outlining how these guidelines are implemented, has to be reviewed and approved by competent authorities and an ethical committee. In this chapter, an overview is given of the unique features of phase 1 trials, and the specific guidelines that apply to setting up, submitting, and conducting phase 1 trials in the European Union.