Key words: Neurotherapeutics; psychotropics; clinical trials; drug development; Phase II, Phase III.

Introduction

In recent years there has been tremendous progress in advancing new treatments for neurologic and psychiatric illnesses. New agents have emerged for the treatment of Alzheimer's disease, Parkinson's disease, multiple sclerosis, epilepsy, migraine, schizophrenia, bipolar illness, depression, and substance abuse disorders. Advances in understanding of basic pathophysiology and molecular biology of brain disorders have led to increasingly sophisticated target identification that guides drug development. Advances in the basic neuroscience and disease mechanisms have been particularly obvious in the neurologic disorders where there is an ever improving understanding of the underlying mechanisms of brain function and brain disease.

Progress in neurotherapeutics has occurred in concert with progress in basic science methodologies, neuroimaging, clinical trial design, and trial analysis. There is an increasing enthusiasm for clinical trials that provide highly credible data with which to guide evidence-based medicine. The United States Food and Drug Administration (US FDA) requires a close link between the clinical trial population tested and the specific indication for which the agent will be approved. This contributes to the proliferation of clinical trials, as industry sponsors of trials seek to expand the populations for which their products are indicated. An increasing number of patients and physicians are involved in clinical trials. Advancing clinical trial methodology has itself become a major endeavor.

Progress in Neurotherapeutics and Neuropsychopharmacology has two objectives:

1. to provide a continuous update of the clinical trials that can be used to inform and improve the care of patients with neurologic and psychiatric illnesses

2. to provide an update on clinical trial methodologies, designs, and outcome assessments.