A Double Blind Clinical Trial of DCS for Food Anxiety
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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|
- Anxiety [ Time Frame: Twice a week for two weeks ] [ Designated as safety issue: No ]Anxiety will be measured at 4 sessions, twice a week for two weeks.
- Body Mass Index [ Time Frame: twice a week for two weeks and at initial assessment ] [ Designated as safety issue: No ]BMI will be measured twice a week for two weeks and once before starting the trial.
- Fear of food [ Time Frame: Twice during 2 weeks ] [ Designated as safety issue: No ]Fear of food will be measured once before and after the trial.
- SUDS [ Time Frame: 2 weeks- twice a week ] [ Designated as safety issue: No ]SUDS will be measured twice a week for two weeks during trial.
|Study Start Date:||February 2013|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
250 mg DCS (setraline) versus placebo
Placebo Comparator: placebo
Please refer to this study by its ClinicalTrials.gov identifier: NCT01996644
|United States, Missouri|
|Saint Louis, Missouri, United States, 63130|
|Contact: Cheri A Levinson, MA 314-935-8627 firstname.lastname@example.org|