NCT00537810

Brief Summary

This study will test the effectiveness of two empirically-supported but distinct treatments for recurrent binge eating in obese patients: 1) Cognitive Behavior Therapy, using a pure self-help approach and 2) sibutramine, an anti-obesity medication also found to have efficacy for binge eating. Self-help Cognitive Behavior Therapy and sibutramine will be administered alone and in combination in a primary care setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for phase_4 obesity

Timeline
Completed

Started Sep 2007

Longer than P75 for phase_4 obesity

Geographic Reach
1 country

3 active sites

Status
completed

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

September 1, 2007

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 1, 2007

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

December 12, 2014

Completed
Last Updated

August 18, 2021

Status Verified

August 1, 2021

Enrollment Period

5.1 years

First QC Date

September 27, 2007

Results QC Date

June 19, 2014

Last Update Submit

August 16, 2021

Conditions

ObesityBinge Eating

Keywords

ObesityBinge eatingSibutramineSelf-helpPrimary care

Outcome Measures

Primary Outcomes (2)

  • Binge Eating (Remission)

    Remission from binge eating (zero binge episodes during previous 28 days)

    4 months treatment; 6 and 12 month follow up post treatment

  • BMI

    BMI (kg/m\^2) was measured 4 months after treatment.

    4 months

Study Arms (4)

Sibutramine

EXPERIMENTAL

Sibutramine 15 mg daily

Drug: Sibutramine

Placebo

PLACEBO COMPARATOR

Placebo Daily

Drug: Placebo

Placebo/CBTsh

EXPERIMENTAL

Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating

Behavioral: Self-help CBT + Sibutramine

Sibutramine/CBTsh

EXPERIMENTAL

Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating

Behavioral: Self-help CBT + Placebo

Interventions

SibutramineDRUG

15 mg daily

Also known as: Meridia
Sibutramine
PlaceboDRUG

Daily

Placebo
Self-help CBT + SibutramineBEHAVIORAL

Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily

Placebo/CBTsh
Self-help CBT + PlaceboBEHAVIORAL

Cognitive behavioral treatment manual for binge eating Placebo daily

Sibutramine/CBTsh

Eligibility Criteria

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

You may qualify if:

  • Obese (BMI \>= 30)

You may not qualify if:

  • Medication regimen that represents medical contraindication to sibutramine
  • Serious unstable or uncontrolled medical conditions that represent contraindication to sibutramine
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Yale Internal Medicine Associates (YIMA)

New Haven, Connecticut, 06510, United States

Location

Yale-New Haven Hospital (YNHH) Primary Care Center (PCC)

New Haven, Connecticut, 06510, United States

Location

Yale Psychiatric Research at Congress Place

New Haven, Connecticut, 06519, United States

Location

Related Publications (3)

  • Grilo CM, Masheb RM, White MA, Gueorguieva R, Barnes RD, Walsh BT, McKenzie KC, Genao I, Garcia R. Treatment of binge eating disorder in racially and ethnically diverse obese patients in primary care: randomized placebo-controlled clinical trial of self-help and medication. Behav Res Ther. 2014 Jul;58:1-9. doi: 10.1016/j.brat.2014.04.002. Epub 2014 May 2.

    PMID: 24857821RESULT

  • Correction to Grilo et al. (2015). J Consult Clin Psychol. 2015 Aug;83(4):747. doi: 10.1037/ccp0000043.

    PMID: 26214545DERIVED

  • Grilo CM, White MA, Masheb RM, Gueorguieva R. Predicting meaningful outcomes to medication and self-help treatments for binge-eating disorder in primary care: The significance of early rapid response. J Consult Clin Psychol. 2015 Apr;83(2):387-94. doi: 10.1037/a0038635. Epub 2015 Jan 26.

    PMID: 25622201DERIVED

MeSH Terms

Conditions

ObesityBulimia

Interventions

sibutramine

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperphagiaSigns and Symptoms, Digestive

Results Point of Contact

Title
Dr. Carlos Grilo
Organization
Yale University School of Medicine
carlos.grilo@yale.edu
2037852792

Study Officials

  • Carlos M. Grilo, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

September 27, 2007

First Posted

October 1, 2007

Study Start

September 1, 2007

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

August 18, 2021

Results First Posted

December 12, 2014

Record last verified: 2021-08

Locations

US(3)