Food Exposure Therapy in Anorexia Nervosa

Study Overview
=================
Brief Summary
-----------------
This is a research study to determine whether a medication called D-cycloserine (DCS) in combination with a type of psychotherapy called Exposure Therapy is helpful to patients with anorexia nervosa.

Detailed Description
-----------------
This is a research study to determine whether a medication called D-cycloserine (DCS) in combination with a type of psychotherapy called Exposure Therapy is helpful to patients with anorexia nervosa. DCS is approved by the FDA as an antibiotic medication, but has not been approved by the FDA for the treatment of anorexia nervosa. Past studies have found that DCS together with Exposure Therapy can help people with height phobia, social phobia, and obsessive compulsive disorder. Anorexia nervosa often includes phobia-like fears, obsessive thoughts, and compulsive rituals, so the current study aims to determine whether DCS paired with Exposure Therapy can also help people with anorexia nervosa. Anorexia nervosa is a disorder characterized by self-starvation, extreme weight loss, and difficulty maintaining a normal weight. You have been asked to participate in this study because you have been given a diagnosis of anorexia nervosa. In this study you will receive one of three therapies: Exposure Therapy with DCS, Exposure Therapy with placebo (inactive medication), or Treatment as Usual. You will participate in a total of four test meals in a laboratory setting. A total of 70 individuals with anorexia nervosa will participate in this study. Twenty individuals who have never had an eating disorder will participate in one portion of this study.

Official Title
-----------------
Food Exposure Therapy in Anorexia Nervosa

Conditions
-----------------
Anorexia Nervosa

Intervention / Treatment
-----------------
* Behavioral: Exposure Therapy + D-Cycloserine
* Behavioral: Exposure Therapy + Placebo
* Behavioral: Supportive Psychotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for Patients: DSM-IV-TR™ diagnosis of anorexia nervosa (restricting or binge-purge subtype) on admission Subjects will have achieved 90% of ideal body weight (IBW) Age 18-45 Medically stable Participation in inpatient treatment Subjects must have signed informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. Exclusion Criteria for Patients: Any other current major Axis I disorder, except OCD or MDD (mild) On psychotropic medication, including benzodiazepines (At the start of the study, subjects will be free of fluoxetine for 4 weeks, and free of all other medications for a minimum of 2 weeks.) History of a seizure disorder Abnormal liver function Renal insufficiency Known hypersensitivity to D-cycloserine Pregnant or lactating Acute suicidality (suicidality or self injury in the last 3 months) Inclusion Criteria for Healthy Controls: BMI ≥ 19.0 kg/m2 Age 18-45 years Subjects must have signed informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. Exclusion Criteria for Healthy Controls: Current Major Axis I disorder (including Eating Disorder, Major Depression,Bipolar Disorder, Schizophrenia, Substance Abuse/Dependence) History of an Eating Disorder Current use of psychotropic medication or other medication known to affect mood and/or anxiety (e.g. b-agonist inhalers, oral steroids) Major medical condition

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EXP-DCS/Exposure-D-cycloserine<br>Exposure Therapy + D-Cycloserine | Behavioral: Exposure Therapy + D-Cycloserine<br>* Exposure therapy with d-cycloserine medication<br>|
| EXP-PBO<br>Exposure Therapy + Placebo | Behavioral: Exposure Therapy + Placebo<br>* Exposure therapy with placebo medication<br>|
| SP<br>Supportive psychotherapy | Behavioral: Supportive Psychotherapy<br>* Supportive psychotherapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |