Clinical trial NCT00402584: A Study to Examine the Efficacy and Safety of Meridia® (Sibutramine Hydrochloride) in Binge-Eating Disorder
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Binge Eating Disorder
Obesity
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2006-11-22
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The frequency of binge eating episodes (binges/week), defined as the mean number of binges per week in 2-week intervals
timeFrame: 6 months
Secondary outcomes:
measure: Change from baseline in frequency of binge days (or mean days per week when the participant had one or more binges)
timeFrame: 6 months
measure: Change from baseline in Body Weight
timeFrame: 6 months
measure: Change from baseline in BMI
timeFrame: 6 months
measure: Change from baseline in global improvement
timeFrame: 6 months
measure: Change from baseline in eating pathology (TFEQ)
timeFrame: 6 months
measure: Change from baseline in quality of life (IWQOL-Lite).
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Abbott
name: Peter Bacher, MD
role: STUDY_DIRECTOR
References:
citation: 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.