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Completed

NCT Number: NCT00402584

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

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.

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Key information

Conditions

Binge Eating Disorder Binge-Eating Disorder Body Weight Feeding and Eating Disorders Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

sibutramine

Drug

Primary outcomes

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

    Time frame: 6 months

Secondary outcomes

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

    Time frame: 6 months

  2. Change from baseline in Body Weight

    Time frame: 6 months

  3. Change from baseline in BMI

    Time frame: 6 months

  4. Change from baseline in global improvement

    Time frame: 6 months

  5. Change from baseline in eating pathology (TFEQ)

    Time frame: 6 months

  6. Change from baseline in quality of life (IWQOL-Lite).

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study to Examine the Efficacy and Safety of Meridia (Sibutramine Hydrochloride) in Binge-Eating Disorder

Important dates

Study start
2000
First posted
Nov 22, 2006
Registry last updated
Aug 31, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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