- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01996644
A Double Blind Clinical Trial of DCS for Food Anxiety
March 26, 2018 updated by: Washington University School of Medicine
A Double Blind Clinical Trial of DCS for Food Anxiety for Patients With Anorexia and Bulimia Nervosa
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study investigated if DCS vs placebo augmented food exposure in individuals with eating disorders.
Study Type
Interventional
Enrollment (Actual)
47
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Missouri
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Saint Louis, Missouri, United States, 63130
- Washington University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 63 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosed with Anorexia Nervosa, Bulimia Nervosa, Eating Disorder Not Otherwise Specified
Exclusion Criteria:
- Pregnant or planning on becoming pregnant
- Psychotic or Manic
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Setraline
250 mg DCS (setraline) versus placebo plus exposure
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250mg DCS
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Placebo Comparator: placebo
Placebo group plus exposure
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Placebo
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Twice a week for two weeks
|
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.
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twice a week for two weeks and at initial assessment
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Twice during 2 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
February 1, 2014
Study Registration Dates
First Submitted
November 18, 2013
First Submitted That Met QC Criteria
November 21, 2013
First Posted (Estimate)
November 27, 2013
Study Record Updates
Last Update Posted (Actual)
March 27, 2018
Last Update Submitted That Met QC Criteria
March 26, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201212062
- F31MH096433-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anorexia and Bulimia Nervosa
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University of California, San DiegoRecruitingAnorexia Nervosa | Bulimia Nervosa | Atypical Anorexia Nervosa | Atypical Bulimia NervosaUnited States
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Yeshiva UniversityYale UniversityRecruitingAnorexia Nervosa | Bulimia Nervosa | Anorexia Nervosa, Atypical | Bulimia; AtypicalUnited States
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Linnaeus UniversityGöteborg University; Linkoeping UniversityRecruitingBulimia Nervosa | Major Depression | Anorexia Nervosa/BulimiaSweden
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Rosemary Claire RodenChildren's Miracle NetworkEnrolling by invitationBulimia Nervosa | Impulsive Behavior | Purging (Eating Disorders) | Eating Disorders | Eating Disorders in Adolescence | Anorexia Nervosa/Bulimia | Anorexia in Adolescence | Anorexia Nervosa, Atypical | Anorexia Nervosa, Binge Eating/Purging TypeUnited States
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University Hospital, ToulouseUnknownAnorexia Nervosa/BulimiaFrance
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Maastricht UniversityZonMw: The Netherlands Organisation for Health Research and Development; Utrecht... and other collaboratorsRecruitingAnorexia Nervosa | Bulimia Nervosa | Atypical Anorexia Nervosa (Other Specified Eating Disorder) | Atypical Bulimia Nervosa (Other Specified Eating Disorder)Netherlands
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The Miriam HospitalUnknownEating Disorders in Adolescence | Anorexia Nervosa/Bulimia | Anorexia Nervosa Restricting TypeUnited States
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University Health Network, TorontoKlarman Family FoundationCompletedAnorexia Nervosa | Bulimia Nervosa
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Drexel UniversityNational Institute of Mental Health (NIMH)Active, not recruitingBinge-Eating Disorder | Bulimia Nervosa | Binge Eating | Bulimia; Atypical | Binge-Eating and Purging Type Anorexia NervosaUnited States
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Children's Mercy Hospital Kansas CityUniversity of Kansas Medical CenterRecruitingBulimia Nervosa | Binge Eating | Purging (Eating Disorders) | Eating Disorders | Anorexia Nervosa, AtypicalUnited States