Status:
TERMINATED
Studying the Effects of Sibutramine on Eating Behavior
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
AstraZeneca
Conditions:
Obesity
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
Obesity is a major public health concern, and the search for useful pharmacologic interventions is ongoing. This study aims to develop a comprehensive series of assessments to directly assess eating b...
Detailed Description
We will recruit 48 moderately obese men and women seeking weight-loss treatment to participate in a 3-week, randomized, double-blind, cross-over trial of sibutramine 15mg or placebo daily. At the end ...
Eligibility Criteria
Inclusion
- moderately obese
- stable weight for a minimum of 3 months
- systolic blood pressure less than or equal to 140 mm Hg
- diastolic blood pressure less than or equal to 90 mm Hg
- pulse less than or equal to 95 beats per minute
- English language proficiency
Exclusion
- on medications known to affect appetite, weight, or metabolism
- current or past history of: binge eating disorder, anorexia nervosa or bulimia nervosa, major depression
- current or past evidence of psychosis, bipolar illness
- current or past history of alcohol or drug abuse or dependence
- known history of learning disorder or developmental disability
- current or past attention deficit hyperactivity disorders
- low platelet count
- current diabetes mellitus
- uncontrolled asthma, or controlled only with oral steroids
- hypothyroidism not adequately treated
- pregnancy, planning to become pregnant, or lactation within the previous 6 months
- history of neurological disorder or injury
- history of moderate or severe head injury
- waist circumference greater than 188 cm
- indwelling metallic object, non-removable metal jewelery, medicinal patch or recent metallic ink tattoo
- pacemaker
- metallic implants
- medication patches
- significant claustrophobia
- color blindness
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01170364
Start Date
February 1 2009
End Date
October 1 2010
Last Update
August 30 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
New York State Psychiatric Institute
New York, New York, United States, 10032