Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
University of Cincinnati Jazz Pharmaceuticals |
---|---|
Information provided by: | University of Cincinnati |
ClinicalTrials.gov Identifier: | NCT00514995 |
The purpose of this research study is to study the effectiveness, tolerability and safety of sodium oxybate in outpatients with binge eating disorder.
Condition | Intervention | Phase |
---|---|---|
Binge Eating Disorder |
Drug: Sodium Oxybate |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
Estimated Enrollment: | 15 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Sodium Oxybate
4.5 g/night - 9 g/night, liquid taken twice per night
|
Ages Eligible for Study: | 21 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients will meet DSM-IV-TR criteria for BED for at least the last 6 months, determined by the Structured Clinical Interview for DSM-IV-TR (SCID) (72) and supported by the Eating Disorder Examination (EDE) (73). These criteria are as follows:
Recurrent episodes of binge eating. An episode of binge eating is characterized by both of the following:
The binge eating episodes are associated with at least three of the following:
Female subjects must either:
Exclusion Criteria:
Contact: Anna Guerdjikova, PhD | 513-558-9336 | anna.guerdjikova@uc.edu |
United States, Ohio | |
University of Cincinnati | Recruiting |
Cincinnati, Ohio, United States, 45267-0559 |
Principal Investigator: | Susan L. McElroy, MD | University of Cincinnati |
Responsible Party: | University of Cincinnati ( Susan L. McElroy, MD / Professor ) |
Study ID Numbers: | McElroy |
Study First Received: | August 8, 2007 |
Last Updated: | July 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00514995 |
Health Authority: | United States: Institutional Review Board |
Signs and Symptoms Bulimia Nervosa Signs and Symptoms, Digestive Mental Disorders |
Bulimia Sodium Oxybate Eating Disorders Hyperphagia |
Anesthetics, Intravenous Adjuvants, Anesthesia Pathologic Processes Disease Anesthetics, General Therapeutic Uses |
Physiological Effects of Drugs Central Nervous System Depressants Anesthetics Central Nervous System Agents Pharmacologic Actions |