Trial of Quetiapine in Anorexia Nervosa

Study Overview
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Brief Summary
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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.

Official Title
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Double-blind Placebo-controlled Trial of Quetiapine in Anorexia Nervosa

Conditions
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Anorexia Nervosa

Intervention / Treatment
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* Drug: Quetiapine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>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). | Drug: Placebo<br>* 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 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.<br>|
| Experimental: Quetiapine<br>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. | Drug: Quetiapine<br>* 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.<br>* Other names: Seroquel;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Scores on the STAI (State-Trait Anxiety Inventory) | The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. | Day 1 to LOCF (up to 8 weeks) | 
| Differences in Scores on the HAM-D (Hamilton Depression Rating Scale) | 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. | Day 1 to LOCF (up to 8 weeks) | 
| Differences in Scores on the PANNSS (The Positive and Negative Syndrome Scale) | 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. | Day 1 to LOCF (up to 8 weeks) |