Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00140426
Status:
COMPLETED
Last Update Posted:
2016-02-02
First Post:
2005-08-31
Brief Title:
A Double-blind Placebo Controlled Trial of Risperidone for the Treatment of Anorexia Nervosa
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
A Double-blind Placebo Controlled Trial of Risperidone for the Treatment of Anorexia Nervosa
Status:
COMPLETED
Status Verified Date:
2015-12
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:
The aim of this pilot study is to determine the safety and efficacy of risperidone for the treatment of anorexia nervosa
Hypothesis 1 Subjects on risperidone will show a more significant decrease in body image distortion and Eating Disorder Inventory -2 scores than subjects on placebo
Hypothesis 2 Subjects on risperidone will reach and maintain at or above 90 Ideal body weight sooner than controls
Hypothesis 1 Subjects on risperidone will show a more significant decrease in body image distortion and Eating Disorder Inventory -2 scores than subjects on placebo
Hypothesis 2 Subjects on risperidone will reach and maintain at or above 90 Ideal body weight sooner than controls
Detailed Description:
The lack of effective medications for the symptoms of anorexia nervosa AN combined with early promising findings in case reports Risperidone and Olanzapine and one open study of olanzapine have led to increased use of these medications for individuals with AN This double-blind placebo controlled study of risperidone will attempt to determine if risperidone is effective in decreasing core symptoms of anorexia nervosa and decreasing the length of time required to reach and maintain at or about 90 Ideal body weight The safety of risperidone in this population will also be examined through monitoring of Extrapyramidal Symptoms Tardive Dyskinesia Electrocardiogramss Resting Energy Expenditure liver enzymes and other blood chemistry Other possible variables which may mediate the recovery process or be impacted by risperidonesuch as leptin and anxiety symptoms are also being measured
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5M01RR000069-45 | NIH | None | httpsreporternihgovquickSearch5M01RR000069-45 |