Trial of Quetiapine in Anorexia Nervosa | RxWiki

Trial of Quetiapine in Anorexia Nervosa

Overview[ - collapse ][ - ]

Purpose	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	Anorexia Nervosa
Intervention	Drug: Quetiapine
Phase	N/A
Sponsor	University of California, San Diego
Responsible Party	University of California, San Diego
ClinicalTrials.gov Identifier	NCT00518973
First Received	August 20, 2007
Last Updated	February 16, 2010
Last verified	December 2009

Tracking Information[ + expand ][ + ]

First Received Date	August 20, 2007
Last Updated Date	February 16, 2010
Start Date	July 2006
Estimated Primary Completion Date	May 2009
Current Primary Outcome Measures	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]
Current Secondary Outcome Measures	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]

Descriptive Information[ + expand ][ + ]

Brief Title	Trial of Quetiapine in Anorexia Nervosa
Official Title	Double-blind Placebo-controlled Trial of Quetiapine in Anorexia Nervosa
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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	N/A
Study Design	Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Condition	Anorexia Nervosa
Intervention	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 Names: Seroquel
Study Arm (s)	Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	10
Estimated Completion Date	May 2009
Estimated Primary Completion Date	May 2009
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.
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Megan Klabunde, MA 858-534-8019 edresearch@ucsd.edu
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00518973
Other Study ID Numbers	051027
Has Data Monitoring Committee	No
Information Provided By	University of California, San Diego
Study Sponsor	University of California, San Diego
Collaborators	University of South Florida
Investigators	Principal Investigator: Walter Kaye, MD University of California, San Diego and University of Pittsburg
Verification Date	December 2009

Locations[ + expand ][ + ]

UCSD Department of Psychiatry Center for Eating Disorder Research	San Diego, California, United States, 92037 Contact: Megan Klabunde, MA \| 858-534-8019 \| edresearch@ucsd.edu Principal Investigator: Walter Kaye, MD Recruiting