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Sponsored by: |
University of Cincinnati |
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Information provided by: | University of Cincinnati |
ClinicalTrials.gov Identifier: | NCT00607789 |
The purpose of this research study is to test the safety of duloxetine and see what effects (good and bad) it has on you and your binge eating disorder and comorbid depressive disorder (depression occurring with binge eating disorder) compared to placebo (inactive pill).
Condition | Intervention | Phase |
---|---|---|
Binge Eating Depression |
Drug: duloxetine Drug: placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment |
Estimated Enrollment: | 40 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: duloxetine
30 mg/day - 120 mg/day
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2: Placebo Comparator |
Drug: placebo
identical to study drug
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Subjects will meet the DSM-IV criteria for a diagnosis of binge eating disorder (BED) for at least the last 6 months. The DSM-IV criteria are as follows:
Exclusion Criteria:
Contact: Anna Guerdjikova, PhD | 513-558-9336 | anna.guerdjikova@uc.edu |
United States, Ohio | |
University of CIncinnati | Recruiting |
Cincinnati, Ohio, United States, 45267-0559 |
Principal Investigator: | Erik B Nelson, MD | University of Cincinnati |
Responsible Party: | University of Cincinnati ( Erik B. Nelson, MD ) |
Study ID Numbers: | Nelson #2 |
Study First Received: | January 23, 2008 |
Last Updated: | July 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00607789 |
Health Authority: | United States: Institutional Review Board |
Signs and Symptoms Bulimia Nervosa Dopamine Depression Signs and Symptoms, Digestive Bulimia |
Depressive Disorder Serotonin Duloxetine Eating Disorders Behavioral Symptoms Hyperphagia |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Physiological Effects of Drugs Psychotropic Drugs |
Serotonin Uptake Inhibitors Pharmacologic Actions Serotonin Agents Therapeutic Uses Dopamine Agents Central Nervous System Agents Antidepressive Agents |