Anorexia and Bulimia Nervosa Clinical Trial
Official title:
A Double Blind Clinical Trial of DCS for Food Anxiety for Patients With Anorexia and Bulimia Nervosa
| Verified date | March 2018 |
| Source | Washington University School of Medicine |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 47 |
| Est. completion date | February 2014 |
| Est. primary completion date | February 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 14 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Diagnosed with Anorexia Nervosa, Bulimia Nervosa, Eating Disorder Not Otherwise Specified Exclusion Criteria: - Pregnant or planning on becoming pregnant - Psychotic or Manic |
| Country | Name | City | State |
|---|---|---|---|
| United States | Washington University | Saint Louis | Missouri |
| Lead Sponsor | Collaborator |
|---|---|
| Washington University School of Medicine | National Institute of Mental Health (NIMH) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Fear of Food Measure | 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. | Twice during 2 weeks | |
| Primary | 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. |
Twice a week for two weeks | |
| Primary | 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. | twice a week for two weeks and at initial assessment |