- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00518973
Trial of Quetiapine in Anorexia Nervosa
June 24, 2019 updated by: Walter Kaye, University of California, San Diego
Double-blind Placebo-controlled Trial of Quetiapine in Anorexia Nervosa
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Diego, California, United States, 92037
- UCSD Department of Psychiatry Center for Eating Disorder Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
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).
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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.
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Experimental: Quetiapine
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.
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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.
Other Names:
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What is the study measuring?
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)
Time Frame: Day 1 to LOCF (up to 8 weeks)
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The YBC-EDS is an eight-item scale assessing severity of preoccupations and rituals.
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Day 1 to LOCF (up to 8 weeks)
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Difference in Scores on the EDI-2 (Eating Disorders Inventory)
Time Frame: Day 1 to LOCF (up to 8 weeks)
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The EDI consists of 8 subscales measuring drive for thinness, bulimia, body dissatisfaction, ineffectiveness, perfectionism, interpersonal distrust, interoceptive awareness, and maturity fears
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Day 1 to LOCF (up to 8 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in Scores on the STAI (State-Trait Anxiety Inventory)
Time Frame: Day 1 to LOCF (up to 8 weeks)
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The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety.
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Day 1 to LOCF (up to 8 weeks)
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Differences in Scores on the HAM-D (Hamilton Depression Rating Scale)
Time Frame: Day 1 to LOCF (up to 8 weeks)
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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.
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Day 1 to LOCF (up to 8 weeks)
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Differences in Scores on the PANNSS (The Positive and Negative Syndrome Scale)
Time Frame: Day 1 to LOCF (up to 8 weeks)
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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.
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Day 1 to LOCF (up to 8 weeks)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Walter Kaye, MD, University of California, San Diego and University of Pittsburg
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2006
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
August 20, 2007
First Submitted That Met QC Criteria
August 20, 2007
First Posted (Estimate)
August 21, 2007
Study Record Updates
Last Update Posted (Actual)
July 17, 2019
Last Update Submitted That Met QC Criteria
June 24, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 051027
- QUET0376
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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