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A Double Blind Clinical Trial of DCS for Food Anxiety

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01996644
First Posted: November 27, 2013
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Washington University School of Medicine
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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 ]
    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 ]
    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 ]
    Fear of food will be measured once before and after the trial.

  • SUDS [ Time Frame: 2 weeks- twice a week ]
    SUDS will be measured twice a week for two weeks during trial.


Enrollment: 47
Study Start Date: February 2013
Study Completion Date: February 2014
Primary Completion Date: February 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01996644


Locations
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63130
Sponsors and Collaborators
Washington University School of Medicine
National Institute of Mental Health (NIMH)
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01996644     History of Changes
Other Study ID Numbers: 201212062
F31MH096433-01 ( U.S. NIH Grant/Contract )
First Submitted: November 18, 2013
First Posted: November 27, 2013
Last Update Posted: October 12, 2017
Last Verified: December 2014

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

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