Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2026-01-02 @ 2:47 AM
Study NCT ID:
NCT00760695
Status:
COMPLETED
Last Update Posted:
2013-05-10
First Post:
2008-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cannabinoid Receptor (CB1) Agonist Treatment in Severe Chronic Anorexia Nervosa
Sponsor:
Odense University Hospital
Organization:
Study Overview
Official Title:
Cannabinoid CB1 Receptor Agonist Treatment in Severe Chronic Anorexia Nervosa
Status:
COMPLETED
Status Verified Date:
2013-05
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:
A pilot study designed to reveal the effects of Marinol / dronabinol, a CB 1 agonist.
Primary end point: To estimate weight gain and EDI scores in patients receiving Marinol compared to placebo
Secondary end points: Motor and inner restlessness and hormonal changes during the treatment.
Primary end point: To estimate weight gain and EDI scores in patients receiving Marinol compared to placebo
Secondary end points: Motor and inner restlessness and hormonal changes during the treatment.
Detailed Description:
The goals of this study are to reveal through a pilot trial if treatment of patients with severe chronic AN with Marinol® (dronabinol, a CB1 agonist) has significant effect on:
* Weight
* Eating Disorder Inventory (EDI) scale
* Motor and inner restlessness (estimated by accelerometry)
* Endocrine parameters (see below, paragraph 4.4) This study is a randomized, double blinded, placebo controlled cross over study. 24 patients with chronic AN meeting the inclusion criteria will be randomized either to receive Marinol® or placebo. After four weeks the two groups will undergo a wash-out period and after that will receive the opposite therapeutic regime for another four weeks.
* Weight
* Eating Disorder Inventory (EDI) scale
* Motor and inner restlessness (estimated by accelerometry)
* Endocrine parameters (see below, paragraph 4.4) This study is a randomized, double blinded, placebo controlled cross over study. 24 patients with chronic AN meeting the inclusion criteria will be randomized either to receive Marinol® or placebo. After four weeks the two groups will undergo a wash-out period and after that will receive the opposite therapeutic regime for another four weeks.
Study Oversight
Has Oversight DMC:
True
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?: