A Double Blind, Placebo Controlled Trial of Quetiapine in Anorexia Nervosa, a Dual Site Study

This study is currently recruiting participants.

Verified by University of South Florida, January 2008

Sponsors and Collaborators:	University of South Florida University of California, San Diego
Information provided by:	University of South Florida
ClinicalTrials.gov Identifier:	NCT00584688

Purpose

Research studies raise the possibility that medications such as quetiapine may improve mood or reduce obsessions in people with anorexia nervosa and may even help to normalize appetite. The medication quetiapine also known as seroquel works by activating certain systems in the brain, such as ones known as dopamine and serotonin chemical systems in the brain.

Condition	Intervention	Phase
Anorexia Nervosa	Drug: quetiapine	Phase II

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Double Blind, Placebo Controlled Trial of Quetiapine in Anorexia Nervosa, a Dual Site Study

Further study details as provided by University of South Florida:

Primary Outcome Measures:

To determine efficacy of seroquel in anorexia nervosa [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	February 2007
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Intervention Details:

quetiapine dosage will be titrated to subject tolerance beginning at 50 mg every 24 hours upwards to 400 mg every 24 hours.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Must be aged 18-65
Must be at least 15% below ideal body weight

Exclusion Criteria:

Allergy to quetiapine
Diagnosis of schizophrenia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00584688

Contacts

Contact: Patti L Lowery	813.974.3633	plowery@health.usf.edu
Contact: Anita Schoolnik, MEd	813.974.2926	aschoolnik@health.usf.edu

Locations

United States, Florida
University of South Floirda	Recruiting
tampa, Florida, United States, 33613
Principal Investigator: Pauline S Powers, MD

Sponsors and Collaborators

University of South Florida

University of California, San Diego

More Information

USF Health Clinical Studies/Principal Investigator: Pauline Powers,MD This link exits the ClinicalTrials.gov site

Responsible Party:	University of South Florida ( Pauline Powers M.D. Principal Investigator )
Study ID Numbers:	0825
Study First Received:	December 21, 2007
Last Updated:	June 18, 2008
ClinicalTrials.gov Identifier:	NCT00584688
Health Authority:	United States: Institutional Review Board

Keywords provided by University of South Florida:

anorexia
nervosa
eating
disorder
study

research
clinical
trial
psychiatry
psychiatric

Study placed in the following topic categories:

Signs and Symptoms
Quetiapine
Signs and Symptoms, Digestive
Mental Disorders

Anorexia
Anorexia Nervosa
Eating Disorders

Additional relevant MeSH terms:

Tranquilizing Agents
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs

Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009