Cholecystokinin for Reducing Binge Eating in People With Bulimia Nervosa

What Was Tested

In this not phased trial, researchers set out to test Cholecystokinin (CCK).

It had two arms (groups): Cholecystokinin (experimental) and Saline (placebo comparator).

Participants will receive intravenous saline plus cholescystokinin.

Participants will receive intravenous saline only.

The registry classes the interventions as procedure.

More on the Plan

Bulimia Nervosa (BN) is a serious eating disorder that is characterized by frequent uncontrolled eating binges.

These binges are often followed by compensatory behavior, including the following: self-induced vomiting; misuse of laxatives, diuretics, enemas, or other medications to induce purging; fasting; or excessive exercise.

Cholecystokinin (CCK) is a hormone that is released by the small intestine, and functions as a trigger for digestion and hunger suppression.

People with BN often have disturbances in the release of CCK, which may contribute to their binge eating behavior.

Who Took Part

Enrollment: 6 actual participants took part.

It was open to women only aged from 18 years up to 55 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Meets DSM-IV criteria for BN. BN duration of more than 1 year.

The full record lists 4 inclusion and 17 exclusion criteria; among the exclusions: current or lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder, as defined by dsm-iv-tr criteria; 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.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

The Cholecystokinin (CCK) group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Cholecystokinin (CCK) study: the participants and staff both knew the treatment.

It started in 2003-10 with completion listed for 2008-10.

It ran at 1 site in United States.

Its stated primary purpose is diagnostic.

What Was Measured

Researchers chose this as the main measure: Amount of food consumed after administration of CCK (measured upon study completion) (time frame: Measured at Day 4).

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Cholecystokinin (CCK) in 6 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cholecystokinin (CCK) compound page, all human trials.