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ClinicalTrials.gov Identifier: NCT00518973
Recruitment Status : Unknown
Verified December 2009 by University of California, San Diego. Recruitment status was: Recruiting
This research study is being held at UCSD to determine whether the medication Quetiapine helps people suffering from anorexia nervosa by reducing core eating disorders symptoms. This study will see if the medication Quetiapine helps symptoms of anxiety, depression, and obsessionality, in addition to increasing BMI. Men and women between the ages of 18-65 and are currently suffering from anorexia nervosa are needed.
Subjects will start with 25mg hs on day 1, 25mg bid on day 2, 25mg am and 50mg hs on day 3, 50mg bid on day 4, 50mg am and 75mg hs on day five, and 75mg bid on day six. Dosage will be increased further on an individual basis as determined by the study physician and as tolerated by the subject with a maximum dosage of 400 mg. Dose can be reduced as determined by clinical judgment. In order to determine the most effective dose, the dose of Quetiapine (or placebo) will be titrated at intervals by staff according to the previously stated guidelines, the Pittsburgh Quetiapine Medication Management Assessment and Interview. Subjects will be interviewed about the factors described above and medication dose will be adjusted upward or downward depending upon symptom persistence or side effects.
Primarily we will seek to show that Quetiapine is superior to placebo in terms of reducing core eating disorder symptoms on the Yale-Brown-Cornell Eating Disorder Scale (YBC-EDS) and the Eating Disorders Inventory-2. [ Time Frame: Eight weeks ]
Secondary Outcome Measures :
We seek to show that Quetiapine is superior to placebo in reducing anxiety, depression, obsessionality, or weight gain in patients with AN. We also will seek to show that Quetiapine is superior to placebo at reducing positive and negative symptoms. [ Time Frame: Eight weeks ]
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Ages Eligible for Study:
18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Meet criteria for DSM-IV anorexia nervosa (restricting or binge-eating/purging types)
At least 15% below ideal body weight
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.
Subjects will not be included in the study who present with any of the following:
Schizophrenia or schizoaffective disorder (DSM-IV)
Any ECG abnormality considered clinically significant by the investigator
Subjects with liver enzymes elevated two times or more above normal
Other laboratory abnormalities considered clinically significant by the investigator including laboratory deviations requiring acute medical intervention
Pregnant women, women of childbearing potential not using medically accepted means of contraception (abstinence, IUD, birth control pills, barrier devices or implanted progesterone rods stabilized for at least three months), and lactating women
Serious suicide risk
Any medical condition that would preclude the outpatient treatment of anorexia nervosa or the use of quetiapine
Organic brain disease
History of severe allergies
Multiple adverse drug reactions or known allergy to quetiapine
Use of neuroleptic medications (except benzodiazepines) within 7 days preceding randomization
History of alcohol or substance abuse disorder as defined in the DSM-IV within the past 3 months.