Trial of Quetiapine in Anorexia Nervosa

University of California San Diego

Status: Completed

Conditions: Anorexia Nervosa

Treatments: Drug: Quetiapine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00518973

051027

QUET0376

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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21 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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).

Treatment:

Drug: Placebo

Quetiapine

Experimental group

Description:

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.

Treatment:

Drug: Quetiapine