Sodium Oxybate in the Treatment of Binge Eating Disorder

This study has been completed.
Sponsor:
Collaborators:
Jazz Pharmaceuticals
University of Cincinnati
Information provided by:
Lindner Center of HOPE
ClinicalTrials.gov Identifier:
NCT00514995
First received: August 8, 2007
Last updated: June 21, 2011
Last verified: June 2011
  Purpose

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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Lindner Center of HOPE:

Primary Outcome Measures:
  • The primary outcome measure will be the weekly frequency of binge-eating episodes (binge frequency). [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcome measures will include weekly frequency of binge days; body mass index; CGI-severity scores; YBOCS-BE modified for Binge Eating scores; Eating Inventory scores; and MADRS total scores. [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: August 2007
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Sodium Oxybate
4.5 g/night - 9 g/night, liquid taken twice per night

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

      • eating, in discrete period of time (eg, within any two hour period), an amount of food that is definitely larger than most people would eat in a similar period of time under similar circumstances
      • a sense of lack of control over eating during the episode (eg, a feeling that one cannot stop eating or control what or how much one is eating)
    • The binge eating episodes are associated with at least three of the following:

      • eating much more rapidly than normal
      • eating until uncomfortably full
      • eating large amounts of food when not feeling physically hungry
      • eating alone because of being embarrassed by how much one is eating
      • feeling disgusted with oneself, depressed, or feeling very guilty after overeating
    • Marked distress regarding binge eating.
    • The binge eating occurs, on average, at least two days a week for six months.
    • Does not occur exclusively during the course of bulimia nervosa and anorexia nervosa.
  • Men or women, from the ages of 21 through 65 years.
  • Female subjects must either:

    • be incapable of pregnancy because of hysterectomy or tubal ligation.
    • if heterosexually active and capable of pregnancy, have been using an acceptable method of contraception (hormonal contraceptives, intrauterine device, spermicide and barrier or double barrier methods) for at least 1 month before study entry and agree to continue the use of one of these contraception methods for the duration of the study.
    • if sexually abstinent and capable of pregnancy, agree to continue abstinence or to use an acceptable method of birth control (either hormonal contraceptives, intrauterine device, spermicide and barrier or double barrier method) should sexual activity commence.

Exclusion Criteria:

  • Have a current body mass index < 18kg/m2 or > 40kg/m2.
  • Women who are pregnant or lactating and women of childbearing potential who are not taking adequate contraceptive measures. (All women of childbearing potential will have a negative pregnancy test before entering the study.)
  • Subjects who are displaying current clinically significant depressive symptoms, defined as a Montgomery Asberg Depression Rating Scale (MADRS) (74) > 1324, or a major depressive episode by DSM-IV-TR criteria (1).
  • Subjects who have a current or past history of clinically significant suicidality (as determined by psychiatric history, SCID interview, and MADRS suicide item #10) Subjects who have made > 1 lifetime suicide attempt and those with a MADRS suicide item score > 2 will be excluded from participation.
  • Subjects who have a lifetime history of a DSM-IV-TR diagnosis of a substance abuse or dependence disorder, except for nicotine abuse or dependence (as determined by psychiatric history, SCID interview, and urine toxicology; see below).
  • Subjects who have a lifetime history of a DSM-IV-TR psychotic disorder, bipolar disorder, or dementia.
  • Subjects who have a history of a personality disorder (eg, schizotypal, borderline, or antisocial) which might interfere with assessment or compliance with study procedures.
  • Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease which could interfere with diagnosis, assessment, or treatment of binge eating disorder with sodium oxybate. Patients should be biochemically euthyroid prior to entering the study.
  • History of obstructive sleep apnea (OBS) or receiving a high risk score for OBS on the Berlin Questionnaire (75).
  • Subjects requiring treatment with any drug which might interact adversely with or obscure the action of the study medication (e.g. stimulants, sympathomimetics, antidepressants, carbonic anhydrase inhibitors, anti-obesity drugs, drugs with CNS depressant effects).
  • Subjects who have received any psychoactive medication within one week prior to randomization.
  • Subjects who have begun and/or are receiving formal psychotherapy (cognitive behavioral therapy, interpersonal therapy, or dietary behavioral therapy) for BED or weight loss within the past 3 months.
  • Subjects previously enrolled in this study or have previously been treated with sodium oxybate.
  • Subjects who have received an experimental drug or used an experimental device within 30 days.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00514995

Locations
United States, Ohio
Lindner Center of HOPE
Mason, Ohio, United States, 45040
Sponsors and Collaborators
Lindner Center of HOPE
Jazz Pharmaceuticals
University of Cincinnati
Investigators
Principal Investigator: Susan L. McElroy, MD University of Cincinnati
  More Information

Publications:
Responsible Party: Susan L. McElroy, MD / Professor, Lindner Center of HOPE and University of Cincinnati
ClinicalTrials.gov Identifier: NCT00514995     History of Changes
Other Study ID Numbers: McElroy
Study First Received: August 8, 2007
Last Updated: June 21, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Binge-Eating Disorder
Bulimia
Disease
Eating Disorders
Hyperphagia
Mental Disorders
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive
Sodium Oxybate
Adjuvants, Anesthesia
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014