Studying the Effects of Sibutramine on Eating Behavior
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Obesity |
Drug: Sibutramine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Basic Science |
| Official Title: | Studying the Effects of Sibutramine on Eating Behavior |
- weight loss (lbs) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- caloric intake [ Time Frame: 2 days ] [ Designated as safety issue: No ]
| Enrollment: | 17 |
| Study Start Date: | February 2009 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Sibutramine |
Drug: Sibutramine
1 week of active sibutramine (15mg)
Other Name: Meridia
|
| Placebo Comparator: Placebo |
Drug: Sibutramine
1 week of active sibutramine (15mg)
Other Name: Meridia
|
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 of weeks 1 and 3, subjects will be asked to participate in a two-day/three-night stay in the Residential Laboratory or BSU of NYSPI for comprehensive assessments. The major outcome variable will be the difference in total daily caloric intake between sibutramine and placebo.
Assessments will concentrate on three main components of eating behavior: eating patterns, psychological processing, and neurocognitive function. Eating behavior studies will examine objective variables such as meal size, meal frequency, and subjective aspects of eating such as hunger and fullness. Psychological studies will measure hedonics, including craving, behavioral restraint, and impulsivity. Neurocognitive function assessment will gather information about decision-making, such as the effects of distractors (food and non-food) on task performance. Additionally, drawing from the field of behavioral neuroeconomics, tasks that assess decision-making and the influence of irrational factors on decisions will be assessed. Neuroimaging (fMRI) procedures will also be conducted, and will augment the psychological and neurocognitive assessments by providing a window into the underlying neural circuitry involved.
Following the double-blind phase, participants will be offered open treatment with sibutramine for weight loss.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 ADHD
- 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
Contacts and Locations| United States, New York | |
| New York State Psychiatric Institute | |
| New York, New York, United States, 10032 | |
| Principal Investigator: | Laurel Mayer, M.D. | New York State Psychiatric Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | New York State Psychiatric Institute |
| ClinicalTrials.gov Identifier: | NCT01170364 History of Changes |
| Other Study ID Numbers: | 5821 |
| Study First Received: | April 26, 2010 |
| Last Updated: | February 27, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by New York State Psychiatric Institute:
|
Obesity sibutramine eating behavior |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Sibutramine |
Appetite Depressants Anti-Obesity Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Antidepressive Agents Psychotropic Drugs |
ClinicalTrials.gov processed this record on October 17, 2012
