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Studying the Effects of Sibutramine on Eating Behavior

This study has been terminated.
(Terminated due to sibutramine being withdrawn from the market.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01170364
First Posted: July 27, 2010
Last Update Posted: August 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
New York State Psychiatric Institute
  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 Phase
Obesity Drug: Sibutramine Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Studying the Effects of Sibutramine on Eating Behavior

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

Primary Outcome Measures:
  • 24 Hour Measured Caloric Intake [ Time Frame: 1 week ]
    The primary outcome measure is 24-hour food intake assessed by 24 hour weighed intake after one week of sibutramine administration compared to one week of placebo administration.


Enrollment: 14
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
Participants in this arm receive sibutramine 15mg for one week followed by two weeks of placebo.
Drug: Sibutramine
1 week of active sibutramine (15mg)
Other Name: Meridia
Drug: Placebo
2 weeks of placebo
Other Name: sugar pill
Experimental: Placebo
Participants are prescribed two weeks of placebo, followed by one week of 15mg sibutramine.
Drug: Sibutramine
1 week of active sibutramine (15mg)
Other Name: Meridia
Drug: Placebo
2 weeks of placebo
Other Name: sugar pill

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 Biological Studies Unit of the New York State Psychiatric Institute 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01170364     History of Changes
Other Study ID Numbers: 5821
First Submitted: April 26, 2010
First Posted: July 27, 2010
Results First Submitted: December 13, 2012
Results First Posted: July 31, 2017
Last Update Posted: August 30, 2017
Last Verified: June 2017

Keywords provided by New York State Psychiatric Institute:
Obesity
sibutramine
eating behavior

Additional relevant MeSH terms:
Sibutramine
Antidepressive Agents
Psychotropic Drugs
Appetite Depressants
Anti-Obesity Agents