N/A
N=15
Trial of Quetiapine in Anorexia Nervosa
Anorexia Nervosa
Bottom Line
View on ClinicalTrials.gov: NCT00518973 ↗Enrolled (actual)
15
Serious AEs
20.0%
Results posted
Jul 2019
Primary outcome: Primary: Hours Occupied by Preoccupations and Rituals Assessed by Yale-Brown-Cornell Eating Disorder Scale (YBC-EDS) — NA; NA; NA; NA Hours — p=.15
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Quetiapine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hours Occupied by Preoccupations and Rituals Assessed by Yale-Brown-Cornell Eating Disorder Scale (YBC-EDS) |
NA; NA; NA; NA | .15 |
| PRIMARY Difference in Scores on the EDI-2 (Eating Disorders Inventory) |
NA; NA | .72 |
| SECONDARY Difference in Scores on the STAI (State-Trait Anxiety Inventory) |
NA; NA; NA; NA | .48 |
| SECONDARY Differences in Scores on the HAM-D (Hamilton Depression Rating Scale) |
NA; NA | .83 |
| SECONDARY Differences in Scores on the PANNSS (The Positive and Negative Syndrome Scale) |
NA; NA; NA; NA; NA; NA | .40 |
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.
Data sourced from ClinicalTrials.gov (NCT00518973). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.