A Double Blind Clinical Trial of DCS for Food Anxiety

Not Applicable

Completed

• Conditions: Anorexia and Bulimia Nervosa
• Interventions: Drug: Setraline; Drug: Placebo vs Setraline

• Registration Number: NCT01996644
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-11-18
• Study First Submitted QC: 2013-11-21
• Study First Posted: 2013-11-27
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Results First Submitted: 2015-06-01
• Status Verified: 2018-03
• Results First Submitted QC: 2018-03-26
• Last Update Submitted: 2018-03-26
• Results First Posted: 2018-03-27
• Last Update Posted: 2018-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

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

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Exclusion Criteria

• Pregnant or planning on becoming pregnant
• Psychotic or Manic

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Setraline	Setraline	250 mg DCS (setraline) versus placebo plus exposure
placebo	Placebo vs Setraline	Placebo group plus exposure

Primary Outcome Measures

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

Trial Locations

Locations (1)

Washington University; 🇺🇸 Saint Louis, Missouri, United States