NCT01170364

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 behavior, cognitive functioning, and psychological functioning under sibutramine and placebo conditions.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_4 obesity

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 27, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
6.8 years until next milestone

Results Posted

Study results publicly available

July 31, 2017

Completed
Last Updated

August 30, 2017

Status Verified

June 1, 2017

Enrollment Period

1.7 years

First QC Date

April 26, 2010

Results QC Date

December 13, 2012

Last Update Submit

August 1, 2017

Conditions

Obesity

Keywords

Obesitysibutramineeating behavior

Outcome Measures

Primary Outcomes (1)

  • 24 Hour Measured Caloric Intake

    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.

    1 week

Study Arms (2)

Sibutramine

EXPERIMENTAL

Participants in this arm receive sibutramine 15mg for one week followed by two weeks of placebo.

Drug: SibutramineDrug: Placebo

Placebo

EXPERIMENTAL

Participants are prescribed two weeks of placebo, followed by one week of 15mg sibutramine.

Drug: SibutramineDrug: Placebo

Interventions

SibutramineDRUG

1 week of active sibutramine (15mg)

Also known as: Meridia
PlaceboSibutramine
PlaceboDRUG

2 weeks of placebo

Also known as: sugar pill
PlaceboSibutramine

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

ObesityFeeding Behavior

Interventions

sibutramineSugars

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

Carbohydrates

Limitations and Caveats

Early termination of the study given the withdrawal of sibutramine from the US market.

Results Point of Contact

Title
Dr. Laurel Mayer
Organization
NYPInstitute
lsm16@columbia.edu
646-774-8067

Study Officials

  • Laurel Mayer, M.D.

    New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2010

First Posted

July 27, 2010

Study Start

February 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

August 30, 2017

Results First Posted

July 31, 2017

Record last verified: 2017-06

Locations

US(1)