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Trial of Quetiapine in Anorexia Nervosa

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ClinicalTrials.gov Identifier: NCT00518973
Recruitment Status : Unknown
Verified December 2009 by University of California, San Diego.
Recruitment status was:  Recruiting
First Posted : August 21, 2007
Last Update Posted : February 17, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Anorexia Nervosa Drug: Quetiapine

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Double-blind Placebo-controlled Trial of Quetiapine in Anorexia Nervosa
Study Start Date : July 2006
Estimated Primary Completion Date : May 2009
Estimated Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    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

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00518973


Contacts
Contact: Megan Klabunde, MA 858-534-8019 edresearch@ucsd.edu

Locations
United States, California
UCSD Department of Psychiatry Center for Eating Disorder Research Recruiting
San Diego, California, United States, 92037
Contact: Megan Klabunde, MA    858-534-8019    edresearch@ucsd.edu   
Principal Investigator: Walter Kaye, MD         
Sponsors and Collaborators
University of California, San Diego
University of South Florida
Investigators
Principal Investigator: Walter Kaye, MD University of California, San Diego and University of Pittsburg
More Information

Responsible Party: Walter Kaye, MD, University of California San Diego
ClinicalTrials.gov Identifier: NCT00518973     History of Changes
Other Study ID Numbers: 051027
QUET0376
First Posted: August 21, 2007    Key Record Dates
Last Update Posted: February 17, 2010
Last Verified: December 2009

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs