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

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...

Date First Received: December 21, 2007

Last Updated: March 19, 2009

Verified by: University of South Florida, March 2009

Clinical Trial Phase: Phase 2 | Start Date: February 2007

Overall Status: Recruiting

Estimated Enrollment: 30

Brief Summary

Official Title: “A Double Blind, Placebo Controlled Trial of Quetiapine in Anorexia Nervosa, a Dual Site Study”

Condition Keyword(s):

Intervention(s):

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2009

Intervention(s) in this Clinical Trial

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

Outcome Measures for this Clinical Trial

Primary Measures

  • To determine efficacy of seroquel in anorexia nervosa
    • Time Frame: 8 weeks
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

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

Exclusion Criteria:

  • Allergy to quetiapine
  • Diagnosis of schizophrenia

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Sponsor Information

Lead Sponsor: University of South Florida

Overall Clinical Trial Officials and Contacts

Overall Contact: Patti Lowery 813.974.2415 plowery@health.usf.edu

Additional Information

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00584688

Study ID Number: 0825

ClinicalTrials.gov Identifier: NCT00584688

Health Authority: United States: Institutional Review Board

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

Clinical Trials Authorship and Review

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