Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT00755820
Status:
COMPLETED
Last Update Posted:
2012-10-26
First Post:
2008-09-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Food Exposure Therapy in Anorexia Nervosa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000856', 'term': 'Anorexia Nervosa'}], 'ancestors': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007171', 'term': 'Implosive Therapy'}, {'id': 'D003523', 'term': 'Cycloserine'}], 'ancestors': [{'id': 'D003887', 'term': 'Desensitization, Psychologic'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D007555', 'term': 'Isoxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D023303', 'term': 'Oxazolidinones'}, {'id': 'D010080', 'term': 'Oxazoles'}, {'id': 'D012694', 'term': 'Serine'}, {'id': 'D021542', 'term': 'Amino Acids, Neutral'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-25', 'studyFirstSubmitDate': '2008-09-18', 'studyFirstSubmitQcDate': '2008-09-18', 'lastUpdatePostDateStruct': {'date': '2012-10-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anorexia Nervosa']}, 'referencesModule': {'references': [{'pmid': '20570701', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Inpatients receiving treatment for anorexia nervosa', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for Patients:\n\n* DSM-IV-TR™ diagnosis of anorexia nervosa (restricting or binge-purge subtype) on admission\n* Subjects will have achieved 90% of ideal body weight (IBW)\n* Age 18-45\n* Medically stable\n* Participation in inpatient treatment\n* 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.\n\nExclusion Criteria for Patients:\n\n* Any other current major Axis I disorder, except OCD or MDD (mild)\n* 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.)\n* History of a seizure disorder\n* Abnormal liver function\n* Renal insufficiency\n* Known hypersensitivity to D-cycloserine\n* Pregnant or lactating\n* Acute suicidality (suicidality or self injury in the last 3 months)\n\nInclusion Criteria for Healthy Controls:\n\n* BMI ≥ 19.0 kg/m2\n* Age 18-45 years\n* 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.\n\nExclusion Criteria for Healthy Controls:\n\n* Current Major Axis I disorder (including Eating Disorder, Major Depression,Bipolar Disorder, Schizophrenia, Substance Abuse/Dependence) History of an Eating Disorder\n* Current use of psychotropic medication or other medication known to affect mood and/or anxiety (e.g. b-agonist inhalers, oral steroids)\n* Major medical condition'}, 'identificationModule': {'nctId': 'NCT00755820', 'briefTitle': 'Food Exposure Therapy in Anorexia Nervosa', 'organization': {'class': 'OTHER', 'fullName': 'New York State Psychiatric Institute'}, 'officialTitle': 'Food Exposure Therapy in Anorexia Nervosa', 'orgStudyIdInfo': {'id': '5457'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'EXP-DCS/Exposure-D-cycloserine', 'description': 'Exposure Therapy + D-Cycloserine', 'interventionNames': ['Behavioral: Exposure Therapy + D-Cycloserine']}, {'label': 'EXP-PBO', 'description': 'Exposure Therapy + Placebo', 'interventionNames': ['Behavioral: Exposure Therapy + Placebo']}, {'label': 'SP', 'description': 'Supportive psychotherapy', 'interventionNames': ['Behavioral: Supportive Psychotherapy']}], 'interventions': [{'name': 'Exposure Therapy + D-Cycloserine', 'type': 'BEHAVIORAL', 'description': 'Exposure therapy with d-cycloserine medication', 'armGroupLabels': ['EXP-DCS/Exposure-D-cycloserine']}, {'name': 'Exposure Therapy + Placebo', 'type': 'BEHAVIORAL', 'description': 'Exposure therapy with placebo medication', 'armGroupLabels': ['EXP-PBO']}, {'name': 'Supportive Psychotherapy', 'type': 'BEHAVIORAL', 'description': 'Supportive psychotherapy', 'armGroupLabels': ['SP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York State Psychiatric Institute', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Joanna Steinglass, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CUMC/NYSPI'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York State Psychiatric Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Hilda & Preston Davis Foundation', 'class': 'OTHER'}, {'name': 'National Alliance for Research on Schizophrenia and Depression', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}