Official Title: “Double-Blind Placebo-Controlled Trial of Quetiapine in Anorexia Nervosa”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment

Study Primary Completion Date: May 2009

Intervention(s) in this Clinical Trial

• Drug: Quetiapine
  • 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.

Primary Measures

• 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
    Safety Issue?: Yes

Secondary 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
    Safety Issue?: Yes

Inclusion Criteria:

• 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.

Exclusion Criteria:

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of California, San Diego

Overall Clinical Trial Officials and Contacts

Walter Kaye, MD Principal Investigator University of California, San Diego and University of Pittsburg  

Overall Contact: Megan Klabunde, MA 858-534-8019 edresearch@ucsd.edu

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00518973

Study ID Number: 051027

ClinicalTrials.gov Identifier: NCT00518973

Health Authority: United States: Institutional Review Board