A Study to Examine the Efficacy and Safety of Meridia® (Sibutramine Hydrochloride) in Binge-Eating Disorder

NCT00402584 | Completed Phase 3

• 1 other identifier: SB237
• Study Type: interventional
• Target: 304
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to examine the safety and efficacy of sibutramine in preventing binge eating episodes. Additionally the study aim is to evaluate the safety and efficacy of sibutramine in reducing body weight in subjects with binge-eating disorder.

Conditions

Binge Eating Disorder; Obesity

Outcome Measures

Primary Outcomes (1)

• The frequency of binge eating episodes (binges/week), defined as the mean number of binges per week in 2-week intervals

  6 months

Secondary Outcomes (6)

• Change from baseline in frequency of binge days (or mean days per week when the participant had one or more binges)

  6 months

• Change from baseline in Body Weight

  6 months

• Change from baseline in BMI

  6 months

• Change from baseline in global improvement

  6 months

• Change from baseline in eating pathology (TFEQ)

  6 months

Interventions

sibutramine DRUG

Eligibility Criteria

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

You may qualify if:

• Participants were men and women
• between the ages of 18 and 65
• with Body Mass Index (BMI) \<45 kg/m2
• who met DSM-IV criteria for BED

You may not qualify if:

• Participants were excluded
• for blood pressure \>140/90 mm Hg
• with pulse \>95 beats/min
• history of stroke, narrow angle glaucoma, cardiac disease, seizures, renal or hepatic dysfunction
• use of insulin, medications known to affect body weight, or certain psychoactive medications (monoamine oxidase inhibitors, lithium, SSRIs, opioids)
• current participation in a weight loss program
• surgical treatment for obesity
• bulimia nervosa or purging in the past 6 months
• alcohol or drug abuse in the past 12 months
• current psychiatric condition being treated with a psychoactive agent
• current major depressive disorder
• history of anorexia nervosa, psychosis, bipolar disorder, or suicide attempts
• psychotherapy within the previous 2 months
• Women were excluded if they were pregnant, lactating, or if fertile, not practicing adequate contraceptive precautions

Sponsors & Collaborators

• Abbott: lead

Related Publications (1)

• Wilfley DE, Crow SJ, Hudson JI, Mitchell JE, Berkowitz RI, Blakesley V, Walsh BT; Sibutramine Binge Eating Disorder Research Group. Efficacy of sibutramine for the treatment of binge eating disorder: a randomized multicenter placebo-controlled double-blind study. Am J Psychiatry. 2008 Jan;165(1):51-8. doi: 10.1176/appi.ajp.2007.06121970. Epub 2007 Dec 3.

  PMID: 18056225 DERIVED

MeSH Terms

Conditions

Binge-Eating Disorder; Obesity

Interventions

sibutramine

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter Bacher, MD

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 20, 2006
• First Posted: November 22, 2006
• Study Start: August 1, 2000
• Last Updated: August 31, 2007

Record last verified: 2007-08