Sodium Oxybate in the Treatment of Binge Eating Disorder

NCT00514995 | Completed Phase 2

• 1 other identifier: McElroy
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to study the effectiveness, tolerability and safety of sodium oxybate in outpatients with binge eating disorder.

Conditions

Binge Eating Disorder

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure will be the weekly frequency of binge-eating episodes (binge frequency).

  16 weeks

Secondary Outcomes (1)

• 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.

  18 weeks

Study Arms (1)

1

EXPERIMENTAL

Drug: Sodium Oxybate

Interventions

Sodium Oxybate DRUG

4.5 g/night - 9 g/night, liquid taken twice per night

1

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lindner Center of HOPE: lead
• Jazz Pharmaceuticals: collaborator
• University of Cincinnati: collaborator

Study Sites (1)

Lindner Center of HOPE

Mason, Ohio, 45040, United States

Location

Related Publications (1)

• McElroy SL, Guerdjikova AI, Winstanley EL, O'Melia AM, Mori N, Keck PE Jr, Hudson JI. Sodium oxybate in the treatment of binge eating disorder: an open-label, prospective study. Int J Eat Disord. 2011 Apr;44(3):262-8. doi: 10.1002/eat.20798.

  PMID: 20209489 RESULT

MeSH Terms

Conditions

Binge-Eating Disorder

Interventions

Sodium Oxybate

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Hydroxybutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids

Study Officials

• Susan L. McElroy, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 8, 2007
• First Posted: August 10, 2007
• Study Start: August 1, 2007
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: June 22, 2011

Record last verified: 2011-06

Locations

US (1)