Trial of Quetiapine in Anorexia Nervosa

Not Applicable

Completed

Brief 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	The primary outcome was to determine the effect of quetiapine compared with placebo in terms of reducing core eating disorder symptoms on the Yale-Brown-Cornell Eating Disorder Scale (YBC-EDS) and the Eating Disorder Inventory-2 (EDI-2).
Quetiapine	Quetiapine	Secondary outcomes were to determine if quetiapine is superior to placebo in reducing anxiety, depression and obsessionality assessed with the State Trait Anxiety Inventory (STAI), Hamilton Depression Rating Scale (HAM D) and Yale-Brown Obsessive Compulsive Scale, respectively. In addition, another secondary goal was to determine if quetiapine is superior to placebo in terms of weight gain. Adverse events were also determined.

Primary Outcome Measures

Name	Time	Method
Hours Occupied by Preoccupations and Rituals Assessed by Yale-Brown-Cornell Eating Disorder Scale (YBC-EDS)	Day 1 to LOCF (up to 8 weeks)	The YBC-EDS is an eight-item scale assessing severity of preoccupations and rituals.
Difference in Scores on the EDI-2 (Eating Disorders Inventory)	Day 1 to LOCF (up to 8 weeks)	The EDI consists of 8 subscales measuring drive for thinness, bulimia, body dissatisfaction, ineffectiveness, perfectionism, interpersonal distrust, interoceptive awareness, and maturity fears

Secondary Outcome Measures

Name	Time	Method
Differences in Scores on the PANNSS (The Positive and Negative Syndrome Scale)	Day 1 to LOCF (up to 8 weeks)	The Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of patients with schizophrenia. A clinical interview is conducted and patient is rated from 1 to 7 on 30 different symptoms based on the interview.
Difference in Scores on the STAI (State-Trait Anxiety Inventory)	Day 1 to LOCF (up to 8 weeks)	The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety.
Differences in Scores on the HAM-D (Hamilton Depression Rating Scale)	Day 1 to LOCF (up to 8 weeks)	Hamilton Depression Rating Scale (HAM-D) form lists 21 items, the scoring is based on the first 17. It generally takes 15-20 minutes to complete the interview and score the results. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2.