Back to resultsA Double Blind, Placebo Controlled Trial of Quetiapine in Anorexia Nervosa, a Dual Site Study
Primary Purpose
Anorexia Nervosa
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
quetiapine
Sponsored by
About this trial
This is an interventional treatment trial for Anorexia Nervosa focused on measuring anorexia, nervosa, eating, disorder, study, research, clinical, trial, psychiatry, psychiatric
Eligibility 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
Sites / Locations
- University of South Floirda
Outcomes
Primary Outcome Measures
To determine efficacy of seroquel in anorexia nervosa
Secondary Outcome Measures
Full Information
NCT ID
NCT00584688
First Posted
December 21, 2007
Last Updated
June 14, 2012
Sponsor
University of South Florida
Collaborators
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT00584688
Brief Title
A Double Blind, Placebo Controlled Trial of Quetiapine in Anorexia Nervosa, a Dual Site Study
Official Title
A Double Blind, Placebo Controlled Trial of Quetiapine in Anorexia Nervosa, a Dual Site Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Terminated
Why Stopped
Lack of Enrollment
Study Start Date
February 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida
Collaborators
University of California, San Diego
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
anorexia, nervosa, eating, disorder, study, research, clinical, trial, psychiatry, psychiatric
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
quetiapine
Intervention Description
quetiapine dosage will be titrated to subject tolerance beginning at 50 mg every 24 hours upwards to 400 mg every 24 hours.
Primary Outcome Measure Information:
Title
To determine efficacy of seroquel in anorexia nervosa
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of South Floirda
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
12. IPD Sharing Statement
Links:
URL
https://hsccf.hsc.usf.edu/clinicalstudies/home.cfm
Description
USF Health Clinical Studies/Principal Investigator: Pauline Powers,MD
Learn more about this trial
A Double Blind, Placebo Controlled Trial of Quetiapine in Anorexia Nervosa, a Dual Site Study
We'll reach out to this number within 24 hrs