A Double Blind Clinical Trial of DCS for Food Anxiety

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Washington University School of Medicine
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01996644
First received: November 18, 2013
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

This is a pilot study investigating if cycloserine (DCS; a learning enhancement medication) augments exposure therapy for food anxiety in patients with anorexia and bulimia nervosa. The investigators expect that (a) exposure therapy will reduce anxiety (b) anxiety will be reduced more in the DCS relative to placebo condition (c) participants in the DCS condition will have a greater increase in Body Mass Index.


Condition Intervention
Anorexia and Bulimia Nervosa
Drug: Sertaline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind Clinical Trial of DCS for Food Anxiety for Patients With Anorexia and Bulimia Nervosa

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Anxiety [ Time Frame: Twice a week for two weeks ] [ Designated as safety issue: No ]
    Anxiety will be measured at 4 sessions, twice a week for two weeks.


Secondary Outcome Measures:
  • Body Mass Index [ Time Frame: twice a week for two weeks and at initial assessment ] [ Designated as safety issue: No ]
    BMI will be measured twice a week for two weeks and once before starting the trial.


Other Outcome Measures:
  • Fear of food [ Time Frame: Twice during 2 weeks ] [ Designated as safety issue: No ]
    Fear of food will be measured once before and after the trial.

  • SUDS [ Time Frame: 2 weeks- twice a week ] [ Designated as safety issue: No ]
    SUDS will be measured twice a week for two weeks during trial.


Estimated Enrollment: 70
Study Start Date: February 2013
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Setraline
250 mg DCS (setraline) versus placebo
Drug: Sertaline
Other Names:
  • D-Cycloserine
  • Cycloserine
Placebo Comparator: placebo
Placebo group
Drug: Sertaline
Other Names:
  • D-Cycloserine
  • Cycloserine

  Eligibility

Ages Eligible for Study:   14 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with Anorexia Nervosa, Bulimia Nervosa, Eating Disorder Not Otherwise Specified

Exclusion Criteria:

  • Pregnant or planning on becoming pregnant
  • Psychotic or Manic
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01996644

Locations
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63130
Contact: Cheri A Levinson, MA    314-935-8627    cherialevinson@wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01996644     History of Changes
Other Study ID Numbers: 201212062, F31MH096433-01
Study First Received: November 18, 2013
Last Updated: November 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Washington University School of Medicine:
Anorexia, Bulimia, Eating disorder, Anxiety, Exposure Therapy

Additional relevant MeSH terms:
Bulimia
Bulimia Nervosa
Anorexia
Anxiety Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Mental Disorders
Hyperphagia
Eating Disorders
Cycloserine
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Renal Agents
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014