Food Exposure Therapy in Anorexia Nervosa

This study has been completed.
Sponsor:
Collaborators:
The Hilda & Preston Davis Foundation
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00755820
First received: September 18, 2008
Last updated: October 25, 2012
Last verified: October 2012

September 18, 2008
October 25, 2012
January 2008
January 2012   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00755820 on ClinicalTrials.gov Archive Site
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Not Provided
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Food Exposure Therapy in Anorexia Nervosa
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.

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.

Observational
Time Perspective: Prospective
Not Provided
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Probability Sample

Inpatients receiving treatment for anorexia nervosa

Anorexia Nervosa
  • Behavioral: Exposure Therapy + D-Cycloserine
    Exposure therapy with d-cycloserine medication
  • Behavioral: Exposure Therapy + Placebo
    Exposure therapy with placebo medication
  • Behavioral: Supportive Psychotherapy
    Supportive psychotherapy
  • EXP-DCS/Exposure-D-cycloserine
    Exposure Therapy + D-Cycloserine
    Intervention: Behavioral: Exposure Therapy + D-Cycloserine
  • EXP-PBO
    Exposure Therapy + Placebo
    Intervention: Behavioral: Exposure Therapy + Placebo
  • SP
    Supportive psychotherapy
    Intervention: Behavioral: Supportive Psychotherapy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
January 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00755820
5457
No
New York State Psychiatric Institute
New York State Psychiatric Institute
  • The Hilda & Preston Davis Foundation
  • National Alliance for Research on Schizophrenia and Depression
Principal Investigator: Joanna Steinglass, M.D. CUMC/NYSPI
New York State Psychiatric Institute
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP