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Food Exposure Therapy in Anorexia Nervosa

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ClinicalTrials.gov Identifier: NCT00755820
Recruitment Status : Completed
First Posted : September 19, 2008
Last Update Posted : October 26, 2012
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Anorexia Nervosa 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 Design

Study Type : Observational
Actual Enrollment : 32 participants
Time Perspective: Prospective
Official Title: Food Exposure Therapy in Anorexia Nervosa
Study Start Date : January 2008
Primary Completion Date : January 2012
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Cycloserine
U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Inpatients receiving treatment for anorexia nervosa
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00755820


Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
The Hilda & Preston Davis Foundation
National Alliance for Research on Schizophrenia and Depression
Investigators
Principal Investigator: Joanna Steinglass, M.D. CUMC/NYSPI
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00755820     History of Changes
Other Study ID Numbers: 5457
First Posted: September 19, 2008    Key Record Dates
Last Update Posted: October 26, 2012
Last Verified: October 2012

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders
Cycloserine
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action