NCT00308776

Brief Summary

This study will determine the effectiveness of administrating a dose of cholecystokinin during a binge eating episode in reducing this eating behavior in people with bulimia nervosa.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2003

Longer than P75 for not_applicable

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

October 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 30, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

May 28, 2012

Status Verified

May 1, 2012

Enrollment Period

5 years

First QC Date

March 28, 2006

Last Update Submit

May 25, 2012

Conditions

Bulimia NervosaEating Disorders

Outcome Measures

Primary Outcomes (1)

  • Amount of food consumed after administration of CCK (measured upon study completion)

    Measured at Day 4

Study Arms (2)

Cholecystokinin

EXPERIMENTAL

Participants will receive intravenous saline plus cholescystokinin.

Procedure: Cholecystokinin (CCK) infusion

Saline

PLACEBO COMPARATOR

Participants will receive intravenous saline only.

Procedure: Saline infusion

Interventions

Cholecystokinin (CCK) infusionPROCEDURE

Participants will begin infusion with a normal saline solution. After 10 minutes of saline infusion, participants will eat a small bowl of tomato soup, followed 20 minutes later by a 15-minute infusion of saline plus CCK.

Cholecystokinin
Saline infusionPROCEDURE

Participants will begin infusion with a normal saline solution. After 10 minutes of saline infusion, participants will eat a small bowl of tomato soup, followed 20 minutes later by a 15-minute infusion of saline only.

Saline

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Meets DSM-IV criteria for BN
  • BN duration of more than 1 year
  • Self-induces vomiting
  • Weighs between 80 and 120% of ideal body weight

You may not qualify if:

  • Significant medical illness
  • Current or lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder, as defined by DSM-IV-TR criteria
  • Current DSM-IV-TR diagnosis of organic mental disorder, factitious disorder, or malingering
  • History of a personality disorder (e.g., schizotypal, borderline, or antisocial) that might interfere with the study procedures
  • At risk for suicide, as defined by the expression of an imminent plan or attempt within the 6 months prior to study entry
  • Currently taking psychotropic medications or medications that affect gastrointestinal function
  • Moderate to severe depression, as defined by a score of greater than 28 on the Hamilton Depression Rating Scale
  • Drug or alcohol abuse within the 3 months prior to study entry
  • Pregnant, planning to become pregnant, or lactating
  • Body mass index (BMI) of less than 18 (underweight)
  • No current or past psychiatric history
  • No history of binge eating or vomiting
  • % of ideal body weight
  • Significant medical illness
  • Current psychotropic medications and current medications that affect GI function
  • +2 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

Bulimia NervosaFeeding and Eating Disorders

Interventions

Cholecystokinin

Condition Hierarchy (Ancestors)

Mental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Gastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • B. Timothy Walsh, MD

    New York State Psychiatric Institute at Columbia University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2006

First Posted

March 30, 2006

Study Start

October 1, 2003

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

May 28, 2012

Record last verified: 2012-05

Locations

US(1)