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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00402584

Enrollment

304

Registered

2006-11-22

Start date

2000-08-31

Completion date

Unknown

Last updated

2007-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Binge Eating Disorder, Obesity

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.

Interventions

DRUGsibutramine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The frequency of binge eating episodes (binges/week), defined as the mean number of binges per week in 2-week intervals	6 months

Secondary

Measure	Time frame
Change from baseline in Body Weight	6 months
Change from baseline in BMI	6 months
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 eating pathology (TFEQ)	6 months
Change from baseline in quality of life (IWQOL-Lite).	6 months
Change from baseline in global improvement	6 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026