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Trial of Quetiapine in Anorexia Nervosa

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by University of California, San Diego.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of South Florida
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00518973
First received: August 20, 2007
Last updated: February 16, 2010
Last verified: December 2009
History of Changes

August 20, 2007
February 16, 2010
July 2006
May 2009   (final data collection date for primary outcome measure)
Primarily we will seek to show that Quetiapine is superior to placebo in terms of reducing core eating disorder symptoms on the Yale-Brown-Cornell Eating Disorder Scale (YBC-EDS) and the Eating Disorders Inventory-2. [ Time Frame: Eight weeks ] [ Designated as safety issue: Yes ]
Primarily we will seek to show that Quetiapine is superior to placebo in terms of reducing core eating disorder symptoms on the Yale-Brown-Cornell Eating Disorder Scale (YBC-EDS) and the Eating Disorders Inventory-2. [ Time Frame: Eight weeks ]
Complete list of historical versions of study NCT00518973 on ClinicalTrials.gov Archive Site
We seek to show that Quetiapine is superior to placebo in reducing anxiety, depression, obsessionality, or weight gain in patients with AN. We also will seek to show that Quetiapine is superior to placebo at reducing positive and negative symptoms. [ Time Frame: Eight weeks ] [ Designated as safety issue: Yes ]
We seek to show that Quetiapine is superior to placebo in reducing anxiety, depression, obsessionality, or weight gain in patients with AN. We also will seek to show that Quetiapine is superior to placebo at reducing positive and negative symptoms. [ Time Frame: Eight weeks ]
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Trial of Quetiapine in Anorexia Nervosa
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.
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Interventional
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Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Anorexia Nervosa
Drug: Quetiapine
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 Name: Seroquel
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
May 2009
May 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact: Megan Klabunde, MA 858-534-8019 edresearch@ucsd.edu
United States
 
NCT00518973
051027, QUET0376
No
Walter Kaye, MD, University of California San Diego
University of California, San Diego
University of South Florida
Principal Investigator: Walter Kaye, MD University of California, San Diego and University of Pittsburg
University of California, San Diego
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP