Food Exposure Therapy in Anorexia Nervosa

NCT ID: NCT00755820

Last Updated: 2012-10-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 32 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2012-01-31

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.

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.

Conditions

Anorexia Nervosa

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

EXP-DCS/Exposure-D-cycloserine

Exposure Therapy + D-Cycloserine

Exposure Therapy + D-Cycloserine

Intervention Type: BEHAVIORAL

Exposure therapy with d-cycloserine medication

EXP-PBO

Exposure Therapy + Placebo

Exposure Therapy + Placebo

Intervention Type: BEHAVIORAL

Exposure therapy with placebo medication

SP

Supportive psychotherapy

Supportive Psychotherapy

Intervention Type: BEHAVIORAL

Supportive psychotherapy

Interventions

Exposure Therapy + D-Cycloserine

Exposure therapy with d-cycloserine medication

Intervention Type: BEHAVIORAL

Exposure Therapy + Placebo

Exposure therapy with placebo medication

Intervention Type: BEHAVIORAL

Supportive Psychotherapy

Supportive psychotherapy

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

• 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

• 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)

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Hilda & Preston Davis Foundation

OTHER

Sponsor Role: collaborator

National Alliance for Research on Schizophrenia and Depression

OTHER

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joanna Steinglass, M.D.

Role: PRINCIPAL_INVESTIGATOR

CUMC/NYSPI

Locations

New York State Psychiatric Institute

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 20570701 (View on PubMed)

Other Identifiers

5457

Identifier Type: -

Identifier Source: org_study_id