NCT01996644

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

Completed NA Results posted Last updated 26 March 2018

What this trial tests

NA trial testing Placebo vs Setraline in Anorexia and Bulimia Nervosa in 47 participants. Completed in 1 February 2014.

Timeline

1 February 2013

Primary endpoint
1 February 2014

1 February 2014

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	47
Start date	1 February 2013
Primary completion	1 February 2014
Estimated completion	1 February 2014
Sites	1 location across United States

Drugs / interventions tested

• Placebo vs Setraline — full drug profile →
• Setraline — full drug profile →

Conditions studied

• Anorexia and Bulimia Nervosa — all drugs for Anorexia and Bulimia Nervosa →

Sponsor

Washington University School of Medicine

Who can join

Adults 14 to 65, any sex, with Anorexia and Bulimia Nervosa. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.
• 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.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. D-Cycloserine facilitation of exposure therapy improves weight regain in patients with anorexia nervosa: a pilot randomized controlled trial.
   Levinson CA, Rodebaugh TL, Fewell L, Kass AE, et al · · 2015 · cited 35× · PMID 26132687 · DOI 10.4088/jcp.14m09299
2. Approved and Pipeline Pharmacological Interventions for Eating Disorders (2010-2025): 15 Years of Progress (or Lack Thereof).
   Hirsch D, Reed J, Naqvi A, Ngor A, et al · · 2026 · PMID 41313392 · DOI 10.1007/s40263-025-01248-7