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Completed

NCT Number: NCT00755820

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

New York State Psychiatric Institute

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exposure Therapy + D-Cycloserine

Behavioral

Exposure therapy with d-cycloserine medication

Exposure Therapy + Placebo

Behavioral

Exposure therapy with placebo medication

supportive psychotherapy

Behavioral

Supportive psychotherapy

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • National Alliance for Research on Schizophrenia and Depression
  • The Hilda & Preston Davis Foundation

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Sep 19, 2008
Registry last updated
Oct 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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