Expired Study
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New York, New York 10032


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.


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. 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.


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


Study is Available At:


Original ID:

5457


NCT ID:

NCT00755820


Secondary ID:


Study Acronym:


Brief Title:

Food Exposure Therapy in Anorexia Nervosa


Official Title:

Food Exposure Therapy in Anorexia Nervosa


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

45 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

New York State Psychiatric Institute


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Time Perspective: Prospective


Number of Arms:

0


Number of Groups:

3


Total Enrollment:

32


Enrollment Type:

Actual


Overall Contact Information

Official Name:Joanna Steinglass, M.D.
Principal Investigator
CUMC/NYSPI

Study Dates

Start Date:January 2008
Completion Date:January 2012
Completion Type:Actual
Primary Completion Date:January 2012
Primary Completion Type:Actual
Verification Date:October 2012
Last Changed Date:October 25, 2012
First Received Date:September 18, 2008

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Behavioral
Name:Exposure Therapy + D-Cycloserine
Description:Exposure therapy with d-cycloserine medication
Arm Name:EXP-DCS/Exposure-D-cycloserine
Intervention Type:Behavioral
Name:Exposure Therapy + Placebo
Description:Exposure therapy with placebo medication
Arm Name:EXP-PBO
Intervention Type:Behavioral
Name:Supportive Psychotherapy
Description:Supportive psychotherapy
Arm Name:SP

Study Arms

Study Arm Type:Other
Arm Name:EXP-DCS/Exposure-D-cycloserine
Description:Exposure Therapy + D-Cycloserine
Study Arm Type:Other
Arm Name:EXP-PBO
Description:Exposure Therapy + Placebo
Study Arm Type:Other
Arm Name:SP
Description:Supportive psychotherapy

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:New York State Psychiatric Institute
Agency Class:Other
Agency Type:Collaborator
Agency Name:The Hilda & Preston Davis Foundation

Samples and Retentions

Study Population: Inpatients receiving treatment for anorexia nervosa
Sample Method:Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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