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Sponsors and Collaborators: |
New York State Psychiatric Institute Hilda and Preston Davis Foundation NARSAD Grant |
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Information provided by: | New York State Psychiatric Institute |
ClinicalTrials.gov Identifier: | NCT00755820 |
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.
Condition | Intervention |
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Anorexia Nervosa |
Behavioral: Exposure Therapy + D-Cycloserine Behavioral: Exposure Therapy + Placebo Behavioral: Supportive Psychotherapy |
Study Type: | Interventional |
Study Design: | Treatment |
Study Start Date: | January 2008 |
Arms | Assigned Interventions |
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EXP-DCS: Experimental | Behavioral: Exposure Therapy + D-Cycloserine |
EXP-PBO: Placebo Comparator | Behavioral: Exposure Therapy + Placebo |
SP: Placebo Comparator | Behavioral: Supportive Psychotherapy |
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria for Patients:
Exclusion Criteria for Patients:
Inclusion Criteria for Healthy Controls:
Exclusion Criteria for Healthy Controls:
Contact: Laura Berner | 212-543-5316 | edru@pi.cpmc.columbia.edu |
United States, New York | |
New York State Psychiatric Institute | Recruiting |
New York, New York, United States, 10032 | |
Contact: Laura 212-543-5316 edru@pi.cpmc.columbia.edu |
Principal Investigator: | Joanna Steinglass, M.D. | CUMC/NYSPI |
Responsible Party: | Columbia University Medical Center/New York State Psychiatric Institute ( Joanna Steinglass, M.D. ) |
Study ID Numbers: | 5457 |
Study First Received: | September 18, 2008 |
Last Updated: | September 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00755820 History of Changes |
Health Authority: | United States: Institutional Review Board |
Antimetabolites Cycloserine Anti-Bacterial Agents Signs and Symptoms Signs and Symptoms, Digestive Mental Disorders |
Anorexia Anti-Infective Agents, Urinary Antitubercular Agents Anorexia Nervosa Eating Disorders |
Antimetabolites Cycloserine Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Signs and Symptoms, Digestive Anti-Infective Agents, Urinary Renal Agents Pharmacologic Actions Antibiotics, Antitubercular |
Anti-Bacterial Agents Signs and Symptoms Mental Disorders Therapeutic Uses Anorexia Antitubercular Agents Anorexia Nervosa Eating Disorders |