Overview

Studying the Effects of Sibutramine on Eating Behavior

Status:
Terminated
Trial end date:
2010-10-01
Target enrollment:
0
Participant gender:
All
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 behavior, cognitive functioning, and psychological functioning under sibutramine and placebo conditions.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
New York State Psychiatric Institute
Collaborator:
AstraZeneca
Treatments:
Sibutramine
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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