Food Exposure Therapy in Anorexia Nervosa

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.

Study Overview

• Status: Completed
• Conditions: Anorexia Nervosa
• Intervention / Treatment: Behavioral: Exposure Therapy + D-Cycloserine; Behavioral: Exposure Therapy + Placebo; Behavioral: Supportive Psychotherapy

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.

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • New York State Psychiatric Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Inpatients receiving treatment for anorexia nervosa

Description

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

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
EXP-DCS/Exposure-D-cycloserine; Exposure Therapy + D-Cycloserine	Behavioral: Exposure Therapy + D-Cycloserine; Exposure therapy with d-cycloserine medication
EXP-PBO; Exposure Therapy + Placebo	Behavioral: Exposure Therapy + Placebo; Exposure therapy with placebo medication
SP; Supportive psychotherapy	Behavioral: Supportive Psychotherapy; Supportive psychotherapy

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute
• Collaborators: National Alliance for Research on Schizophrenia and Depression; The Hilda & Preston Davis Foundation
• Investigators: Principal Investigator: Joanna Steinglass, M.D., CUMC/NYSPI

Publications and helpful links

General Publications

• Steinglass JE, Sysko R, Mayer L, Berner LA, Schebendach J, Wang Y, Chen H, Albano AM, Simpson HB, Walsh BT. Pre-meal anxiety and food intake in anorexia nervosa. Appetite. 2010 Oct;55(2):214-8. doi: 10.1016/j.appet.2010.05.090. Epub 2010 Jun 4.

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: September 18, 2008
• First Submitted That Met QC Criteria: September 18, 2008
• First Posted (Estimate): September 19, 2008

Study Record Updates

• Last Update Posted (Estimate): October 26, 2012
• Last Update Submitted That Met QC Criteria: October 25, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antimetabolites; Anti-Bacterial Agents; Antitubercular Agents; Antibiotics, Antitubercular; Anti-Infective Agents, Urinary; Renal Agents; Cycloserine
• Other Study ID Numbers: 5457