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

Anorexia Nervosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00584688
• Other study ID #: 0825
• Status: Terminated
• Phase: Phase 2
• First received: December 21, 2007
• Last updated: June 14, 2012
• Start date: February 2007
• Est. completion date: August 2009

Study information

• Verified date: March 2009
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: August 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Must be aged 18-65

• Must be at least 15% below ideal body weight

Exclusion Criteria:

• Allergy to quetiapine

• Diagnosis of schizophrenia

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

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

Locations

Country	Name	City	State
United States	University of South Floirda	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine efficacy of seroquel in anorexia nervosa		8 weeks	No

External Links

•   USF Health Clinical Studies/Principal Investigator: Pauline Powers,MD