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A Double Blind Clinical Trial of DCS for Food Anxiety

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ClinicalTrials.gov Identifier: NCT01996644
Recruitment Status : Completed
First Posted : November 27, 2013
Results First Posted : March 27, 2018
Last Update Posted : March 27, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Anorexia and Bulimia Nervosa Drug: Placebo vs Setraline Drug: Setraline Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind Clinical Trial of DCS for Food Anxiety for Patients With Anorexia and Bulimia Nervosa
Study Start Date : February 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Setraline
250 mg DCS (setraline) versus placebo plus exposure
Drug: Setraline
250mg DCS
Placebo Comparator: placebo
Placebo group plus exposure
Drug: Placebo vs Setraline
Placebo
Other Name: Placebo



Primary Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01996644


Locations
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63130
Sponsors and Collaborators
Washington University School of Medicine
National Institute of Mental Health (NIMH)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01996644     History of Changes
Other Study ID Numbers: 201212062
F31MH096433-01 ( U.S. NIH Grant/Contract )
First Posted: November 27, 2013    Key Record Dates
Results First Posted: March 27, 2018
Last Update Posted: March 27, 2018
Last Verified: March 2018

Keywords provided by Washington University School of Medicine:
Anorexia, Bulimia, Anxiety, Exposure

Additional relevant MeSH terms:
Anorexia
Bulimia
Bulimia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Hyperphagia
Feeding and Eating Disorders
Mental Disorders