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CompletedNCT00755820Updated Oct 26, 2012

Food Exposure Therapy in Anorexia Nervosa

An observational study in Anorexia Nervosa, sponsored by New York State Psychiatric Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-10-26.

Sponsored by New York State Psychiatric Institute · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
32
Ages
18 Years to 45 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Anorexia Nervosa
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In context

Anorexia

411 studies on the registry are indexed under Anorexia; 67 are open to participants now.

This study's enrollment of 32 is below the median of 65 across 104 observational studies indexed under Anorexia.

Browse Anorexia studies →

Lead sponsor

New York State Psychiatric Institute is the lead sponsor of 425 studies on the registry; 26 are open to participants now.

Of its 50 completed or terminated interventional studies of FDA-regulated products, 45 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Inpatients receiving treatment for anorexia nervosa

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
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Study design

Time perspective
Prospective
Enrollment
32 participants (actual)

Groups and cohorts

  • EXP-DCS/Exposure-D-cycloserine

    Exposure Therapy + D-Cycloserine

    Behavioral: Exposure Therapy + D-Cycloserine

  • EXP-PBO

    Exposure Therapy + Placebo

    Behavioral: Exposure Therapy + Placebo

  • SP

    Supportive psychotherapy

    Behavioral: Supportive Psychotherapy

Interventions

  • BehavioralExposure Therapy + D-Cycloserine

    Exposure therapy with d-cycloserine medication

  • BehavioralExposure Therapy + Placebo

    Exposure therapy with placebo medication

  • BehavioralSupportive Psychotherapy

    Supportive psychotherapy

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Study locations

1 site
  • New York State Psychiatric Institute
    New York, New York 10032, United States
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References and documents

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. PubMed 20570701 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00755820
Lead sponsor
New York State Psychiatric Institute
Collaborators
The Hilda & Preston Davis Foundation, National Alliance for Research on Schizophrenia and Depression
Responsible party
Sponsor
First posted
Sep 19, 2008
Start date
Jan 2008
Primary completion
Jan 2012
Completion
Jan 2012
Last update
Oct 26, 2012

Study contacts

Joanna Steinglass, M.D.
principal investigator · CUMC/NYSPI

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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