Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00176436
Status:
COMPLETED
Last Update Posted:
2022-03-14
First Post:
2005-09-12
Brief Title:
Atomoxetine for Treatment of Weight Gain in Olanzapine or Clozapine Patients
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Double-Blind Study of Atomoxetine for Weight Management in Patients Taking Olanzapine or Clozapine
Status:
COMPLETED
Status Verified Date:
2022-03
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 study investigates the use of Atomoxetine in combination with exercise and a diet support group Weight Watchersto treat weight gain associated with Olanzapine or clozapine All patients must be adults who have been diagnosed with Schizophrenia or Schizoaffective Disorder
Detailed Description:
The study is a 6 month double-blind trial of atomoxetine in combination with a Weight Watchers group to help patients lose the weight they have gained taking olanzapine or clozapine All participants should have been on Olanzapine or clozapine for at least 6 months and gained 7 of baseline weight or have a BMI of 27 or greater In addition to the group support participants are provided supervised exercise sessions and medical supervision Previous studies of the group process alone were successful in helping patients lose weight It is hoped that the addition of atomoxetine which is known to cause appetite suppression will be more effective in helping subjects lose weight All subjects will receive either atomoxetine or placebo during the 6 month study
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 |
|---|---|---|---|
| F1D-US-X254 | None | None | None |