The research study on the effects of Quetiapine on Anorexia Nervosa is a double-blind placebo controlled single group trial sponsored by the University of California, San Diego (UCSD) and University of South Florida. It is currently recruiting participants to help in the determination of Quetiapine’s effect on anorexia nervosa. As it is a double-blind placebo clinical trial, both participants and researchers will not be aware of who is receiving the actual medication and who is receiving placebos (inactive substances usually in the form of sugar pills) in order to avoid tainting the study with bias from either parties.
The study was started in July 2006 and is expected to be concluded by May of 2009. The primary purpose of the study is to determine whether the medication Quetiapine, aside from its body mass index increasing effect, can help symptoms of anxiety, depression, and obsessionality found in cases of anorexia nervosa. Desired subjects include both males and females between the ages of 18-65 who are currently suffering from anorexia nervosa.
Participant inclusion criteria are: “meets criteria for DSM-IV anorexia nervosa (restricting or binge-eating/purging types), at least 15% below ideal body weight and judged to be reliable to keep clinic visits and able to take all tests and examinations required by the protocol and be able to understand and decide whether or not to sign the Informed Consent. ” Treatment protocol includes the administration of Quetiapine twice a day in the following dosages: 50mg on day 1, 100mg on day 2, 200mg on day 3, 300mg on day 4, and a maximum of 400mg on day 5.
“To determine the most effective dose, the dose of Quetiapine (or placebo) will be blindly titrated at intervals by staff using structured guidelines, the Pittsburgh Quetiapine Medication Management Assessment and interview. ” After which subjects will be interviewed regarding the above described factors and medication dose adjusted upward or downward depending upon symptom persistence or side effects with a minimum dose at 100mg/day. Treatment will last for eight weeks.