Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00330655
Status:
COMPLETED
Last Update Posted:
2007-08-14
First Post:
2006-05-25
Brief Title:
An Open-Label Trial of Memantine in the Treatment of Binge Eating Disorder
Sponsor:
Mclean Hospital
Organization:
Mclean Hospital
Study Overview
Official Title:
An Open-Label Prospective Trial of Memantine in the Treatment of Moderate to Severe Binge Eating Disorder Associated With Obesity
Status:
COMPLETED
Status Verified Date:
2007-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We hypothesize that memantine may be a safe and effective treatment for moderate to severe binge eating disorder associated with obesity
During this 12-week open-label outpatient study male and female subjects between the ages of 18 and 65 years who have moderate to severe binge eating disorder and are obese will be treated with open-label memantine Following this 12-week treatment phase subjects may be eligible to continue into an extension phase which will last an additional 12 weeks During the extension phase subjects will continue open-label memantine treatment
During this 12-week open-label outpatient study male and female subjects between the ages of 18 and 65 years who have moderate to severe binge eating disorder and are obese will be treated with open-label memantine Following this 12-week treatment phase subjects may be eligible to continue into an extension phase which will last an additional 12 weeks During the extension phase subjects will continue open-label memantine treatment
Detailed Description:
Binge eating disorder is a newly recognized disorder characterized by recurrent episodes of binge eating without extreme behaviors to lose weight characteristic of bulimia nervosa or anorexia nervosa and it is associated with overweight and obesity in both clinical and community populations Preliminary clinical data from a recent small 5-week open-label therapeutic trial in obese patients with binge eating disorder in Germany found memantine to be effective in weight reduction and reduction of binge episodes
We plan to study 15 male and female subjects between the ages of 18 and 65 years who have binge eating disorder with 3 or more binge days per week in the 2 weeks prior to baseline and have a body mass index BMI between 30 and 50 kgm2 During the 12-week treatment phase subjects will receive open-label memantine titrated up to 20mgday or the subjects maximum tolerated dose Upon completion of the treatment phase subjects will either taper their study medication and return for a final post-taper visit or continue on their current dose of study medication in the 12-week extension phase
We plan to study 15 male and female subjects between the ages of 18 and 65 years who have binge eating disorder with 3 or more binge days per week in the 2 weeks prior to baseline and have a body mass index BMI between 30 and 50 kgm2 During the 12-week treatment phase subjects will receive open-label memantine titrated up to 20mgday or the subjects maximum tolerated dose Upon completion of the treatment phase subjects will either taper their study medication and return for a final post-taper visit or continue on their current dose of study medication in the 12-week extension phase
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None