Food Exposure Therapy in Anorexia Nervosa
1 other identifier
observational
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2008
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 18, 2008
CompletedFirst Posted
Study publicly available on registry
September 19, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedOctober 26, 2012
October 1, 2012
4 years
September 18, 2008
October 25, 2012
Conditions
Study Arms (3)
EXP-DCS/Exposure-D-cycloserine
Exposure Therapy + D-Cycloserine
EXP-PBO
Exposure Therapy + Placebo
SP
Supportive psychotherapy
Interventions
Exposure therapy with d-cycloserine medication
Eligibility Criteria
Inpatients receiving treatment for anorexia nervosa
You may qualify if:
- 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.
You may not qualify if:
- 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)
- 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.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York State Psychiatric Institute
New York, New York, 10032, United States
Related Publications (1)
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.
PMID: 20570701DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joanna Steinglass, M.D.
CUMC/NYSPI
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2008
First Posted
September 19, 2008
Study Start
January 1, 2008
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
October 26, 2012
Record last verified: 2012-10