Studying the Effects of Sibutramine on Eating Behavior

This study has been terminated.
(Terminated due to sibutramine being withdrawn from the market.)
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01170364
First received: April 26, 2010
Last updated: February 27, 2012
Last verified: February 2012
  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

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • weight loss (lbs) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01170364

Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
AstraZeneca
Investigators
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
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms
Sibutramine
Anti-Obesity Agents
Antidepressive Agents
Appetite Depressants
Central Nervous System Agents
Pharmacologic Actions
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014