Trial of Quetiapine in Anorexia Nervosa
Information source: University of California, San Diego
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anorexia Nervosa
Intervention: Quetiapine (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of California, San Diego Official(s) and/or principal investigator(s):
Walter Kaye, MD, Principal Investigator, Affiliation: University of California, San Diego and University of Pittsburg
Overall contact:
Megan Klabunde, MA, Phone: 858-534-8019, Email: edresearch@ucsd.edu
Summary
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.
Clinical Details
Official title: Double-Blind Placebo-Controlled Trial of Quetiapine in Anorexia Nervosa
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment
Primary outcome: 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.
Secondary outcome: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Megan Klabunde, MA, Phone: 858-534-8019, Email: edresearch@ucsd.edu
UCSD Department of Psychiatry Center for Eating Disorder Research, San Diego, California 92037, United States; Recruiting
Megan Klabunde, MA, Phone: 858-534-8019, Email: edresearch@ucsd.edu
Walter Kaye, MD, Principal Investigator
Additional Information
Starting date: July 2006
Ending date: May 2009
Last updated: February 12, 2009
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