Back to resultsA Double Blind Clinical Trial of DCS for Food Anxiety
Primary Purpose
Anorexia and Bulimia Nervosa
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placebo vs Setraline
Setraline
Sponsored by
About this trial
This is an interventional treatment trial for Anorexia and Bulimia Nervosa focused on measuring Anorexia, Bulimia, Anxiety, Exposure
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with Anorexia Nervosa, Bulimia Nervosa, Eating Disorder Not Otherwise Specified
Exclusion Criteria:
- Pregnant or planning on becoming pregnant
- Psychotic or Manic
Sites / Locations
- Washington University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Setraline
placebo
Arm Description
250 mg DCS (setraline) versus placebo plus exposure
Placebo group plus exposure
Outcomes
Primary Outcome Measures
Anxiety as Measured by the Subjective Units of Distress (Ranging From 1 to 100).
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01996644
First Posted
November 18, 2013
Last Updated
March 26, 2018
Sponsor
Washington University School of Medicine
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT01996644
Brief Title
A Double Blind Clinical Trial of DCS for Food Anxiety
Official Title
A Double Blind Clinical Trial of DCS for Food Anxiety for Patients With Anorexia and Bulimia Nervosa
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia and Bulimia Nervosa
Keywords
Anorexia, Bulimia, Anxiety, Exposure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Setraline
Arm Type
Experimental
Arm Description
250 mg DCS (setraline) versus placebo plus exposure
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo group plus exposure
Intervention Type
Drug
Intervention Name(s)
Placebo vs Setraline
Other Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Setraline
Intervention Description
250mg DCS
Primary Outcome Measure Information:
Title
Anxiety as Measured by the Subjective Units of Distress (Ranging From 1 to 100).
Description
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.
Time Frame
Twice a week for two weeks
Title
Body Mass Index
Description
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.
Time Frame
twice a week for two weeks and at initial assessment
Other Pre-specified Outcome Measures:
Title
Fear of Food Measure
Description
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.
Time Frame
Twice during 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with Anorexia Nervosa, Bulimia Nervosa, Eating Disorder Not Otherwise Specified
Exclusion Criteria:
Pregnant or planning on becoming pregnant
Psychotic or Manic
Facility Information:
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63130
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26132687
Citation
Levinson CA, Rodebaugh TL, Fewell L, Kass AE, Riley EN, Stark L, McCallum K, Lenze EJ. D-Cycloserine facilitation of exposure therapy improves weight regain in patients with anorexia nervosa: a pilot randomized controlled trial. J Clin Psychiatry. 2015 Jun;76(6):e787-93. doi: 10.4088/JCP.14m09299.
Results Reference
derived
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A Double Blind Clinical Trial of DCS for Food Anxiety
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