Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00203450
Status:
COMPLETED
Last Update Posted:
2012-09-03
First Post:
2005-09-12
Brief Title:
Zonegran for the Treatment of Weight Gain Associated With Psychotropic Medication Use A Placebo-Controlled Trial
Sponsor:
Tuscaloosa Research Education Advancement Corporation
Organization:
Tuscaloosa Research Education Advancement Corporation
Study Overview
Official Title:
Zonegran for the Treatment of Weight Gain Associated With Psychotropic Medication Use A Placebo-Controlled Trial
Status:
COMPLETED
Status Verified Date:
2012-08
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:
Zonegran
Brief Summary:
The primary objective of this study is to compare the efficacy of zonisamide Zonegran 100mg - 400mgday and placebo as an adjunctive agent on lowering weight in subjects who have a body mass index BMI of 25 and are on a psychotropic medication with a known side effect of weight gain
Detailed Description:
After the screening period patients fulfilling entrance criteria will be randomized to 100mg of zonisamide or placebo in a 21 ratio respectively Patients will be assessed at baseline and on Weeks 2 4 8 12 and 16-post randomization for weight side effects and symptoms Symptoms will be assessed by the Young Mania Rating Scale YMRS Brief Psychiatric Rating Scale BPRS Hamilton Depression Rating Scale HAMD Hamilton Rating Scale for Anxiety HARS and Self-report measures of general health and mental status at baseline weeks 2 4 8 12and 16 At the conclusion of the study patients will be tapered from the study medication and will return to their primary provider for continued treatment of their psychiatric condition
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 |
|---|---|---|---|
| TREAC Zonegran for Weight Loss | None | None | None |