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A Pilot Study of RDC-0313 (ALKS 33) in Adults With Binge Eating Disorder

2014-08-27 03:14:46 | BioPortfolio

Summary

The purpose of this study is to evaluate the safety and efficacy of daily doses of RDC-0313 (ALKS 33) compared with placebo in adults with binge eating disorder.

Description

Following screening, eligible subjects will be randomized in a 1:1 ratio to RDC-0313 (ALKS 33) or matching placebo. Once-daily dosing will begin at randomization and will continue for 6 weeks. There will be 8 study visits in a 12-week period.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Binge Eating Disorder

Intervention

RDC-0313 (ALKS 33), Placebo

Location

Lindner Center of HOPE
Mason
Ohio
United States
45040

Status

Recruiting

Source

Alkermes

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:46-0400

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Medical and Biotech [MESH] Definitions

A disorder associated with three or more of the following: eating until feeling uncomfortably full; eating large amounts of food when not physically hungry; eating much more rapidly than normal; eating alone due to embarrassment; feeling of disgust, DEPRESSION, or guilt after overeating. Criteria includes occurrence on average, at least 2 days a week for 6 months. The binge eating is not associated with the regular use of inappropriate compensatory behavior (i.e. purging, excessive exercise, etc.) and does not co-occur exclusively with BULIMIA NERVOSA or ANOREXIA NERVOSA. (From DSM-IV, 1994)

An eating disorder that is characterized by a cycle of binge eating (BULIMIA or bingeing) followed by inappropriate acts (purging) to avert weight gain. Purging methods often include self-induced VOMITING, use of LAXATIVES or DIURETICS, excessive exercise, and FASTING.

Little or no appetite for breakfast due to eating more food after dinner than during the meal and eating more than half of daily food intake after dinner hour.

An eating disorder that is characterized by the lack or loss of APPETITE, known as ANOREXIA. Other features include excess fear of becoming OVERWEIGHT; BODY IMAGE disturbance; significant WEIGHT LOSS; refusal to maintain minimal normal weight; and AMENORRHEA. This disorder occurs most frequently in adolescent females. (APA, Thesaurus of Psychological Index Terms, 1994)

Tools used in COOKING or EATING such as cutlery, pots, pans, and dishes.

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