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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:
ClinicalTrials.gov Identifier:
NCT00584688
First Posted: January 2, 2008
Last Update Posted: June 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
University of South Florida
  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
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, 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:


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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT00584688     History of Changes
Other Study ID Numbers: 0825
First Submitted: December 21, 2007
First Posted: January 2, 2008
Last Update Posted: June 18, 2012
Last Verified: March 2009

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
Feeding and Eating Disorders
Mental Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs