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| Sponsor: | University of Cincinnati |
|---|---|
| Information provided by: | University of Cincinnati |
| ClinicalTrials.gov Identifier: | NCT00607789 |
Purpose
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 |
| Study Completion Date: | October 2009 |
| 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
|
| 2: Placebo Comparator |
Drug: placebo
identical to study drug
|
Eligibility| 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:
Contacts and Locations| United States, Ohio | |
| University of Cincinnati and Lindner Center of HOPE | |
| Cincinnati, Ohio, United States, 45219 | |
| Principal Investigator: | Erik B Nelson, MD | University of Cincinnati |
More Information
| 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: | October 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00607789 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Signs and Symptoms, Digestive Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Physiological Effects of Drugs Psychotropic Drugs Duloxetine Hyperphagia Signs and Symptoms Bulimia Nervosa Mental Disorders |
Therapeutic Uses Eating Disorders Antidepressive Agents Depression Depressive Disorder Serotonin Uptake Inhibitors Pharmacologic Actions Behavioral Symptoms Serotonin Agents Bulimia Mood Disorders Dopamine Agents Central Nervous System Agents |