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

This study has been terminated.
(Lack of Enrollment)
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT00584688
First received: December 21, 2007
Last updated: June 14, 2012
Last verified: March 2009
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Double Blind, Placebo Controlled Trial of Quetiapine in Anorexia Nervosa, a Dual Site Study

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 24
Study Start Date: February 2007
Study Completion Date: August 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: quetiapine
    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

Locations
United States, Florida
University of South Floirda
Tampa, Florida, United States, 33613
Sponsors and Collaborators
University of South Florida
University of California, San Diego
  More Information

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

No publications provided

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT00584688     History of Changes
Other Study ID Numbers: 0825
Study First Received: December 21, 2007
Last Updated: June 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Florida:
anorexia
nervosa
eating
disorder
study
 research
clinical
trial
psychiatry
psychiatric

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 June 17, 2013