Anorexia Nervosa Clinical Trial
Official title:
Double-blind Placebo-controlled Trial of Quetiapine in Anorexia Nervosa
NCT number | NCT00518973 |
Other study ID # | 051027 |
Secondary ID | QUET0376 |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2006 |
Est. completion date | May 2010 |
Verified date | June 2019 |
Source | University of California, San Diego |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 21 |
Est. completion date | May 2010 |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
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. |
Country | Name | City | State |
---|---|---|---|
United States | UCSD Department of Psychiatry Center for Eating Disorder Research | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego | University of South Florida |
United States,
Powers PS, Klabunde M, Kaye W. Double-blind placebo-controlled trial of quetiapine in anorexia nervosa. Eur Eat Disord Rev. 2012 Jul;20(4):331-4. doi: 10.1002/erv.2169. Epub 2012 Apr 26. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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 | 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) | |
Secondary | 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) | |
Secondary | 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) |
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