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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Binge Eating Disorder Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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sibutramine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Peter Bacher, MD

Role: STUDY_DIRECTOR

Abbott

References

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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.

Reference Type DERIVED

PMID: 18056225 (View on PubMed)

Other Identifiers

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SB237

Identifier Type: -

Identifier Source: org_study_id