What is Generalized Anxiety Disorder (GAD)? Generalized Anxiety Disorder (GAD) is characterized by excessive worry (more days than not) about a number of events or activities. People with GAD frequently describe having difficulty stopping or controlling their worry. Other symptoms of GAD can include: 1) feelings of restlessness; 2) fatigue; 3) sleep disturbances; 4) irritability, 5) muscle tension; and 6) difficulty concentrating or mind going blank. What is the purpose of this clinical trial? The purpose of this study is to evaluate the safety and effectiveness of an investigational medication in adults ages 18-65 with GAD. The study medication is different from anything currently available by prescription for GAD, and not currently approved by the FDA. Therefore, the use of the study medication for anxiety is considered investigational. To participate in the study, you do not need to have been previously diagnosed with GAD. How long will the study last? In the study, 50% of participants will receive the study medication, 25% of participants will receive an medication (Paxil) which is FDA approved for treating anxiety, and 25% will receive a placebo pill (a fake pill). The study lasts approximately 12 weeks and will involve about 9 visits to our clinic. Most visits will be about 2 hours. Where is the study being conducted? This study is taking place at approximately 42 sites around the world, including here at Regions Hospital in St. Paul, Minnesota. You will meet with a physician and other staff at every visit. Our regular hours are Mon-Fri, 8am-4:30pm. How can I find out if I am eligible to participate in the study? You can call us at 651-739-HELP or you can complete and submit the form below. We'll contact you to provide you with more study information and to determine whether you may be eligible to participate. If I dont want to be in the study what other treatment options are available? GAD was traditionally treated with a class of drugs known as benzodiazepines, such as alprazolam (Xanax) or lorazepam (Ativan). Benzodiazepines have been associated with the possibility of tolerance (needing to take more to get the same effect) and can be habit forming. Benzodiazepines are sometimes thought of as calming medications that take effect quickly, but also wear off until the next dose is taken. Many physicians now prescribe newer antidepressants, several of which have been proven effective for anxiety such as paroxetine (Paxil) and venlafaxine extended release (Effexor XR). Antidepressants work gradually over a period of weeks or months. They are not taken just when a person feels anxious, but rather, are taken daily on a preventative or maintenance basis. Other effective treatment can include psychotherapy, particularly cognitive behavioral therapy (CBT). Although Regions Hospital has used reasonable precautions to safeguard the confidentiality of information received and sent over the Internet or via e-mail, Regions Hospital can not guarantee the confidentiality of such information. Individuals corresponding with us in this manner waive claims regarding any third party's access to or use of confidential information. |
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