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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 |
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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 |
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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:
Recurrent episodes of binge eating. An episode of binge eating is characterized by both of the following:
eating, in a discrete period of time (eg, within any two hour period), an amount of food that is definitely larger than most people would eat in a similar period of time under similar conditions; and a sense of lack of control over eating during the episode (eg, a feeling that one cannot stop eating or control what or how much one is eating).
Exclusion Criteria:
Contact: Anna Guerdjikova, PhD | 513-536-7021 | anna.guerdjikova@lindnercenter.org |
Contact: Tracey Adleta | 513-558-3249 | adletaty@ucmail.uc.edu |
United States, Ohio | |
University of Cincinnati and Lindner Center of HOPE | Recruiting |
Cincinnati, Ohio, United States, 45219 | |
Contact: Tracey Adleta 513-558-3249 adletaty@ucmail.uc.edu | |
Contact: Anna Guerdjikova, PhD 513-536-7021 anna.guerdjikova@lindnercenter.org |
Principal Investigator: | Erik B Nelson, MD | University of Cincinnati |
Responsible Party: | University of Cincinnati & Lindner Center of HOPE ( Erik B. Nelson, MD & Susan McElroy ) |
Study ID Numbers: | Nelson #2 |
Study First Received: | January 23, 2008 |
Last Updated: | February 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00607789 History of Changes |
Health Authority: | United States: Institutional Review Board |
Dopamine Uptake Inhibitors Neurotransmitter Agents Depression Adrenergic Agents Signs and Symptoms, Digestive Psychotropic Drugs Depressive Disorder Serotonin Uptake Inhibitors Duloxetine Serotonin |
Hyperphagia Behavioral Symptoms Bulimia Nervosa Signs and Symptoms Dopamine Bulimia Dopamine Agents Antidepressive Agents Eating Disorders |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Depression Adrenergic Agents Signs and Symptoms, Digestive Molecular Mechanisms of Pharmacological Action Adrenergic Uptake Inhibitors Physiological Effects of Drugs Psychotropic Drugs Serotonin Uptake Inhibitors |
Duloxetine Pharmacologic Actions Hyperphagia Behavioral Symptoms Signs and Symptoms Serotonin Agents Therapeutic Uses Bulimia Dopamine Agents Central Nervous System Agents Antidepressive Agents |