Clinical trial NCT00518973: Trial of Quetiapine in Anorexia Nervosa
Official title: Double-blind Placebo-controlled Trial of Quetiapine in Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anorexia Nervosa
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: University of South Florida
First posted: 2007-08-21
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Hours Occupied by Preoccupations and Rituals Assessed by Yale-Brown-Cornell Eating Disorder Scale (YBC-EDS)
timeFrame: Day 1 to LOCF (up to 8 weeks)
measure: Difference in Scores on the EDI-2 (Eating Disorders Inventory)
timeFrame: Day 1 to LOCF (up to 8 weeks)
Secondary outcomes:
measure: Difference in Scores on the STAI (State-Trait Anxiety Inventory)
timeFrame: Day 1 to LOCF (up to 8 weeks)
measure: Differences in Scores on the HAM-D (Hamilton Depression Rating Scale)
timeFrame: Day 1 to LOCF (up to 8 weeks)
measure: Differences in Scores on the PANNSS (The Positive and Negative Syndrome Scale)
timeFrame: Day 1 to LOCF (up to 8 weeks)
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Department of Psychiatry Center for Eating Disorder Research
state: California
Study officials:
affiliation: University of California, San Diego and University of Pittsburg
name: Walter Kaye, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.