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Trial of Quetiapine in Anorexia Nervosa

Information source: University of California, San Diego
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anorexia Nervosa

Intervention: Quetiapine (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: University of California, San Diego

Official(s) and/or principal investigator(s):
Walter Kaye, MD, Principal Investigator, Affiliation: University of California, San Diego and University of Pittsburg

Overall contact:
Megan Klabunde, MA, Phone: 858-534-8019, Email: edresearch@ucsd.edu

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.

Clinical Details

Official title: Double-blind Placebo-controlled Trial of Quetiapine in Anorexia Nervosa

Study design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

Megan Klabunde, MA, Phone: 858-534-8019, Email: edresearch@ucsd.edu

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

Starting date: July 2006
Last updated: February 16, 2010

Page last updated: August 23, 2015

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