Trial of Quetiapine in Anorexia Nervosa - Full Text View

Sponsor:	University of California, San Diego
Collaborator:	University of South Florida
Information provided by:	University of California, San Diego
ClinicalTrials.gov Identifier:	NCT00518973

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	Intervention
Anorexia Nervosa	Drug: Quetiapine

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Double-blind Placebo-controlled Trial of Quetiapine in Anorexia Nervosa

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Depression Eating Disorders

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Further study details as provided by University of California, San Diego:

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 ]

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 ]

Estimated Enrollment:	10
Study Start Date:	July 2006
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	Walter Kaye, MD, University of California San Diego
ClinicalTrials.gov Identifier:	NCT00518973 History of Changes
Other Study ID Numbers:	051027, QUET0376
Study First Received:	August 20, 2007
Last Updated:	February 16, 2010
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Eating Disorders
Mental Disorders
Quetiapine
Antipsychotic Agents

Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 22, 2012