Skip to main content
OpenTrials
Completed

NCT Number: NCT01996644

A Double Blind Clinical Trial of DCS for Food Anxiety

This is a pilot study investigating if cycloserine (DCS; a learning enhancement medication) augments exposure therapy for food anxiety in patients with anorexia and bulimia nervosa. The investigators expect that (a) exposure therapy will reduce anxiety (b) anxiety will be reduced more in the DCS relative to placebo condition (c) participants in the DCS condition will have a greater increase in Body Mass Index.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anorexia and Bulimia Nervosa Anorexia Anxiety Disorders Bulimia Bulimia Nervosa Feeding and Eating Disorders Hyperphagia Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

14 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University

St Louis, Missouri, 63130, United States

About this study

This study investigated if DCS vs placebo augmented food exposure in individuals with eating disorders.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with Anorexia Nervosa, Bulimia Nervosa, Eating Disorder Not Otherwise Specified

Exclusion criteria

  • Pregnant or planning on becoming pregnant
  • Psychotic or Manic

Treatment and study plan

Placebo vs Setraline

Drug

Placebo

Other names: Placebo

Setraline

Drug

250mg DCS

Primary outcomes

  1. Anxiety as Measured by the Subjective Units of Distress (Ranging From 1 to 100).

    Time frame: Twice a week for two weeks

    Anxiety will be measured at 4 sessions, twice a week for two weeks. Anxiety is combined in a repeated measures ANOVA to give total anxiety decreased across condition.

    Anxiety was measured using the Subjective Units of Distress (ranging from 1 to 100), where 1 is no anxiety and 100 is the most anxiety ever experienced.

  2. Body Mass Index

    Time frame: twice a week for two weeks and at initial assessment

    BMI will be measured twice a week for two weeks and once before starting the trial. BMI is combined in a repeated measures ANOVA to give total BMI difference across condition.Difference in BMI from Time 1 to Time 4 was outcome.

Other outcomes

  1. Fear of Food Measure

    Time frame: Twice during 2 weeks

    The Fear of Food Measure (FOFM) was designed to assess three cognitive behavioral components related to mealtime anxiety. All items are rated on a 1 to 7 Likert-type scale ranging from "not at all" to "very much so." Higher values indicate worse outcomes. The first subscale is the anxiety about eating subscale, which was designed to assess trait levels of fear and anxiety surrounding eating and food. This subscale will be measured once before and after the trial (twice in 2 weeks). Each item (8 items totaled, each scored 1-7; max possible score is 56; min possible score is 8) was added for each time point and time points were averaged together for all participants for both time points.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

A Double Blind Clinical Trial of DCS for Food Anxiety for Patients With Anorexia and Bulimia Nervosa

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 27, 2013
Registry last updated
Mar 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.