Food Exposure Therapy in Anorexia Nervosa

This study is currently recruiting participants.

Verified by New York State Psychiatric Institute, September 2008

First Received: September 18, 2008 No Changes Posted

Sponsors and Collaborators:	New York State Psychiatric Institute Hilda and Preston Davis Foundation NARSAD Grant
Information provided by:	New York State Psychiatric Institute
ClinicalTrials.gov Identifier:	NCT00755820

Purpose

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.

Condition	Intervention
Anorexia Nervosa	Behavioral: Exposure Therapy + D-Cycloserine Behavioral: Exposure Therapy + Placebo Behavioral: Supportive Psychotherapy

Drug Information available for: Cycloserine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

Further study details as provided by New York State Psychiatric Institute:

Study Start Date:

January 2008

Arms	Assigned Interventions
EXP-DCS: Experimental	Behavioral: Exposure Therapy + D-Cycloserine
EXP-PBO: Placebo Comparator	Behavioral: Exposure Therapy + Placebo
SP: Placebo Comparator	Behavioral: Supportive Psychotherapy

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00755820

Contacts

Contact: Laura Berner

212-543-5316

edru@pi.cpmc.columbia.edu

Locations

United States, New York
New York State Psychiatric Institute	Recruiting
New York, New York, United States, 10032
Contact: Laura 212-543-5316 edru@pi.cpmc.columbia.edu

Sponsors and Collaborators

New York State Psychiatric Institute

Hilda and Preston Davis Foundation

NARSAD Grant

Investigators

Principal Investigator:

Joanna Steinglass, M.D.

CUMC/NYSPI

More Information

No publications provided

Responsible Party:	Columbia University Medical Center/New York State Psychiatric Institute ( Joanna Steinglass, M.D. )
Study ID Numbers:	5457
Study First Received:	September 18, 2008
Last Updated:	September 18, 2008
ClinicalTrials.gov Identifier:	NCT00755820 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Antimetabolites
Cycloserine
Anti-Bacterial Agents
Signs and Symptoms
Signs and Symptoms, Digestive
Mental Disorders

Anorexia
Anti-Infective Agents, Urinary
Antitubercular Agents
Anorexia Nervosa
Eating Disorders

Additional relevant MeSH terms:

Antimetabolites
Cycloserine
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Signs and Symptoms, Digestive
Anti-Infective Agents, Urinary
Renal Agents
Pharmacologic Actions
Antibiotics, Antitubercular

Anti-Bacterial Agents
Signs and Symptoms
Mental Disorders
Therapeutic Uses
Anorexia
Antitubercular Agents
Anorexia Nervosa
Eating Disorders

ClinicalTrials.gov processed this record on May 07, 2009