Study tests antidepressant in treating anxiety disorder
Clinical Innovation Group designs and manages large multi-center clinical trial, will collect and evaluate data
Dr.
Olga Brawman-Mintzer, standing, and Terri Putman, director of project operations,
review protocol for GAD trial.
A large multi-center trial—with MUSC as the lead site—to study the effectiveness of a popular antidepressant to control persistent anxiety, also known as generalized anxiety disorder (GAD), started this week at eight centers across the country.
“GAD is an extremely debilitating condition estimated to affect six to eight million people,” said Olga Brawman-Mintzer, M.D., MUSC psychiatrist and clinical principal investigator for the study. It often interferes with the individual’s everyday functioning, resulting in personal pain and suffering for those affected and their families.
It also carries a substantial economic cost to society. The annual economic burden of all anxiety disorders was estimated at $63 billion in 1998.
Patients feel constantly under stress. They are tense, worried, have difficulty sleeping. “Symptoms are chronic and are often worse during times of transition, but they are always present,” said Brawman-Mintzer.
GAD may result in clinical depression and can affect general health because of its influence on other body systems such as the immune system. Patients with the condition frequently go to their physicians with related symptoms such as upset stomach, headaches and chest pain. These patients utilize medical care and frequently require expensive testing to rule out physical causes of the symptoms. Many patients lose time from work, and some are unemployed, requiring government assistance.
For years, valium-like drugs have been prescribed for the condition. But these drugs have major drawbacks, particularly in the treatment of patients with a chronic disease such as GAD. Because of their sedative effects, patients may have difficulty driving or using heavy equipment while taking these medications. They also may be habit forming in certain individuals.
“We’ve done some preliminary tests at MUSC with this medication, which is not addictive and doesn’t have a sedative effect,” said Brawman-Mintzer.
The company manufacturing the drug has asked that the name not be announced yet.
The trial now being conducted is a large double-blind, placebo controlled study coordinated and sponsored by the Clinical Innovation Group of MUSC’s Foundation for Research Development. It is anticipated that 262 patients will be enrolled at MUSC, the University of Pennsylvania, the Birmingham Research Group, Princeton Biomedical Research, the University of California at San Diego, George Washington University, Eastside Comprehensive Medical Services in New York and Four Rivers Clinical Research Inc. in Peducah, Ky.
MUSC’s Clinical Innovation Group with Brawman-Mintzer, designed the study and selected sites across the country specifically for their expertise in treatment of GAD and the diversity of their patient populations.
“We manage the research at each institution, collect and evaluate data,
and prepare articles based on results for peer review in scientific publications,”
according to Terri Putman, director of project operations, MUSC Clinical
Innovation Group.