|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
|---|---|
| Experimental: 1 |
Drug: duloxetine
30 mg/day - 120 mg/day
|
| Placebo Comparator: 2 |
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: | Erik B. Nelson, MD & Susan McElroy, University of Cincinnati & Lindner Center of HOPE |
| ClinicalTrials.gov Identifier: | NCT00607789 History of Changes |
| Other Study ID Numbers: | Nelson #2 |
| Study First Received: | January 23, 2008 |
| Last Updated: | October 9, 2009 |
| Health Authority: | United States: Institutional Review Board |
|
Bulimia Bulimia Nervosa Binge-Eating Disorder Depression Depressive Disorder Hyperphagia Signs and Symptoms, Digestive Signs and Symptoms Eating Disorders Mental Disorders Behavioral Symptoms Mood Disorders Duloxetine Serotonin Uptake Inhibitors |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Adrenergic Uptake Inhibitors Adrenergic Agents Dopamine Uptake Inhibitors Dopamine Agents Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |