Status:
COMPLETED
A Study to Examine the Efficacy and Safety of Meridia® (Sibutramine Hydrochloride) in Binge-Eating Disorder
Lead Sponsor:
Abbott
Conditions:
Binge Eating Disorder
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT00402584
Start Date
August 1 2000
Last Update
August 31 2007
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